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Adverse events and safety | hyperkalemia | The changes in the mean arterial pressure from baseline to week 24 were 1.67 ± 17.13 mmHg in the roxadustat group and 3.82 ± 11.68 mmHg in the ESA group (difference, − 2.14 mmHg; 95% CI, − 8.45 to 4.16). Although no difference was found in the proportion of patients who did not achieve the control goal (roxadustat, 64.29%; ESA, 69.44%), a higher proportion of patients in the ESA group increased or adjusted blood pressure medication (roxadustat, 25.47%; ESA, 47.17%).Roxadustat did not increase the incidence of hyperkalemia (High-sensitivity C-reactive protein levels in the roxadustat ( | PMC10629011 | |
Discussion | CKD, cancer, acidosis, anemia, PD, Inflammation, hyperkalemia, peritonitis, metabolic acidosis | CANCER, ACIDOSIS, ANEMIA, IRON DEFICIENCY, INFLAMMATION, PERITONITIS, METABOLIC ACIDOSIS, CHRONIC INFLAMMATION | In this 24-week clinical study of PD patients, roxadustat significantly reduced the rise of sTFR and reduced the occurrence of functional iron deficiency by lowering hepcidin levels, although there was no significant difference in the incidence of absolute iron deficiency between the two groups. In addition, roxadustat improved anemia and lipid metabolism without increasing the incidence of hyperkalemia, metabolic acidosis, and peritonitis.Since there were 22% of patients who had insufficient iron reserve state the number. The roxadustat group still had significantly improved iron metabolism levels in PD patients, with a smaller proportion of oral iron patients. We suggest that the decreased hepcidin levels and increased iron availability associated with roxadustat may have contributed to these findings [Clinically, TSAT (an index of iron utilization state) < 20% and sFt (an index of iron storage state) < 100 ng/mL is diagnosed as absolute iron deficiency in PD patients. Functional iron deficiency is characterized by TSAT < 20% and normal or elevated sFt levels [Because roxadustat mediates the transition from aerobic to anaerobic metabolism, the immediate consequence of increased glycolysis is tissue acidification and lactic acid overproduction. The acidosis reaction leads to the release of potassium ions from cells, resulting in hyperkalemia [CKD patients often suffer from chronic inflammation due to excessive production and retention of urinary toxins, abnormal intestinal flora, and changes in the integrity of intestinal barrier. Inflammation blocks the output and absorption of iron that bacteria need to survive by stimulating the expression of hepcidin [It should be noted that this study has the following limitations: first of all, this trial is a single-center study, and these participants may not be generalizable to other populations. Secondly, we believe that the use of diuretics and bicarbonate supplements reduced the incidence of hyperkalemia and metabolic acidosis in roxadustat group, but we regret that the use of drug was not counted during the study. Finally, this study only studied the changes in patients’ condition after 24 weeks of treatment, which may not be long enough to observe the safety of roxadustat. The risks of angiogenesis and cancer associated with HIF have been demonstrated, and further studies are needed before firm conclusions can be drawn. | PMC10629011 |
Conclusion | metabolic acidosis, PD, hyperkalemia, peritonitis | METABOLIC ACIDOSIS, PERITONITIS | In conclusion, this 24-week prospective cohort study comparing the efficacy of roxadustat and ESAs in PD patients showed the benefit of roxadustat in improving iron metabolism. In addition to its inhibitory effect on hepcidin, roxadustat also induces the expression of molecules required for iron circulation. Thus, the increased iron consumption observed in the roxadustat group may be attributable not only to enhanced hematopoietic production, but also to improved iron utilization efficiency. Information on the differences in the effects of roxadustat and ESAs on iron metabolism could help in selecting appropriate treatment options for PD patients. Roxadustat displayed a manageable safety with no increased risk of the incidence of hyperkalemia, metabolic acidosis and peritonitis. | PMC10629011 |
Acknowledgements | We would like to extend our sincere gratitude to The Affiliated Hospital of Xuzhou Medical University for providing us with a conducive and comfortable platform during our study. We also deeply appreciate our dear colleagues for their reliable, tireless support and assistance. | PMC10629011 | ||
Author contributions | Conception and design were by XZ, RJ, ZZ and LJ; all authors provided critical intellectual content, contributing to the analysis and interpretation of data and drafting of the manuscript, AR participated in grammar modification, and DS did the overall design, provided the funds and critically revised the important intellectual content in the article. | PMC10629011 | ||
Funding | This study was supported by the National Natural Science Foundation of China (82270731, 82000703); the Jiangsu Provincial Natural Science Foundation (BK20211054); a project of Qing Lan of Jiangsu Province; a project of Jiangsu Provincial Post Graduate Innovation Plan (KYCX21_2701, KYCX22_2903); Science and technology development fund of Affiliated Hospital of Xuzhou Medical University (XYFC2020001; XYFY2020038); Xuzhou key R & D Program (Social Development) (KC20160); Xuzhou Medical leading Talent training Project (XWRCHT20210038); Beanstalk talent of Affiliated Hospital of Xuzhou Medical University; and a project of Practice and Innovation Plan of Jiangsu Province (SJCX21_1147). | PMC10629011 | ||
Availability of data and materials | The data that support the findings of this study are available on request from the corresponding author. | PMC10629011 | ||
Declarations | PMC10629011 | |||
Ethics approval and consent to participate | This study was approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (XYFY-KL39-01). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee. All the enrolled patients signed an informed consent form. | PMC10629011 | ||
Consent for publication | Not applicable. | PMC10629011 | ||
Competing interests | None declared. | PMC10629011 | ||
References | PMC10629011 | |||
Abstract | SIT, overweight/ obesity, 75‐gram glucose, ± | There is evidence supporting that acute sprint interval training (SIT) might improve metabolic responses to postprandial glucose, but results are inconclusive. The aim of the present study was to explore the effects of acute SIT on metabolic response and substrate utilization in individuals with overweight/obesity after an oral 75‐gram glucose challenge. Thirty‐three participants with overweight/ obesity (32.7 ± 8.3 years, 24 male, 9 female) participated in the study and a crossover design was followed. After the 75‐gram glucose load, participants were randomly allocated to two groups: no exercise (resting) or SIT protocol. Metabolic data including respiratory quotient (RQ) and substrate utilization rates (fats and carbohydrates) were collected using the COSMED Q‐NRG + ® calorimeter. The RQ was significantly lower in the acute SIT group (0.76 [0.01]; There is evidence supporting that acute sprint interval training (SIT) might improve metabolic responses to postprandial glucose, but results are inconclusive. The present investigation indicates that acute SIT might have a positive effect on metabolic response to postprandial glucose and, therefore, it could be recommended for improving metabolism response in adults with overweight/obesity. The mechanism(s) involved in substrate utilization with SIT are not fully elucidated and the topic warrants further investigation.
| PMC9875746 | |
INTRODUCTION | obesity, Metabolic disorders, impaired fasting glucose, CVD, abdominal obesity, T2DM | OBESITY, METABOLIC DISORDERS, CARDIOVASCULAR DISEASE, HIGH BLOOD PRESSURE, CVD, CHRONIC DISEASES, INSULIN RESISTANCE, TYPE 2 DIABETES MELLITUS | Metabolic disorders are typically characterized by a constellation of clinical features including abdominal obesity, insulin resistance and/or impaired fasting glucose, and high blood pressure, which are known to increase the risk of developing type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) (Ford, According to the carbohydrate–insulin model of obesity, the intake of high‐glycemic carbohydrates results in elevated postprandial insulin responses, which are believed to promote body fat accumulation, in turn increasing hunger and energy intake (Blundell & Macdiarmid, Efforts to manage chronic diseases have led to attempts to change lifestyle behaviors, and physical exercise has been found to be one of the most important health‐promoting behaviors (Ramírez‐Vélez et al., Performing repeated bouts of high‐intensity “sprint”‐type exercise over several weeks or months induces profound changes in skeletal muscle (Blue et al., Few studies have investigated the acute effect of exercise on people with overweight/obesity, a group that includes the majority of the Colombian adult population, owing to their sedentary behavior and poor health and diet (Ferrari et al., | PMC9875746 |
MATERIALS AND METHODS | PMC9875746 | |||
Participants | ±, overweight or obesity | Thirty‐three participants with overweight or obesity (mean and standard deviation age 32.7 ± 8.3 years; 24 males, 9 females; body mass index 28.6 ± 4.4 kg/mParticipant s' characteristics and fasting measurements (
| PMC9875746 | |
Study design and setting | HEART | The participants performed two different trials in random order and separated by at least 5 days for the following purposes: (1) anthropometric and body composition measurements and completed in random order, no exercise (control, resting group) or (2) SIT performed on a cycle ergometer (Monark 894 E, Monark, Varberg, Sweden). Each trial began at 07:00 a.m. after an overnight fast (10–12 h). They were instructed to avoid caffeine, alcohol, strenuous, and exhaustive physical activity for 2 days before the exercise tests. For the no exercise (control, resting group) and the SIT trial, participants rested in a supine position for 30 min and then either ingested an oral carbohydrate liquid meal (Meal; partial hydrolysate of starch; 75 g glucose in a volume of 250 ml, this is the standard solution used for the oral glucose tolerance test; Dextrosol uva HYCEL; Grupo JAFS). The participants then returned to a supine position just after completing the oral glucose load (75 g) for 1 h. After experimental condition (control or SIT trial), participants remained in rest position 60,120, and 180 min after the ingestion of a 75‐g oral glucose challenge, (Figure Overview of experimental protocol (a), heart rate, and lactate response from eight‐repeated 30‐s “all‐out” intervals (b). Study design (a). Face mask icons represents indirect calorimetry (metabolic cart) assessments. The soda cup icon represents the 75‐g oral glucose dose. The drop icons represent the capillary blood sample assessments. Other assessments were performed only on day 1 (not shown). The study protocol timeline is expressed as hours. BIA, Bioelectrical impedance analysis assessment. Muscle strength (grip strength), anthropometry, and BIA assessments were performed only on day 1. Heart rate (HR ●) and blood lactate (□) concentration relationships to eight‐repeated 30‐s “all‐out” response (b). Data represent mean (standard error). RMR, resting metabolic rate. | PMC9875746 | |
Measurements | Body mass (kg) and height (m) measurements were determined using a balance scale (Seca 284™, SECA). Body mass index was calculated as weight/height | PMC9875746 | ||
Sprint interval training protocol | muscle mass, nausea, 75‐gram glucose | HEART | Participants completed in random order, 5 days apart, no exercise (control, resting group) or SIT performed on a cycle ergometer (Monark 894 E, Monark, Varberg, Sweden). After a baseline measure, 12 min (4 min for SIT and 8 min for recovery interval) of exercise was performed 90‐min after an oral 75‐gram glucose load. Sessions consisted of eight‐repeated 30‐s “all‐out” efforts on a manual braked cycle ergometer against a resistance equivalent to 0.075 kg/kg muscle mass (i.e., a Wingate test). Participants were instructed to begin pedaling as fast as possible against the ergometer's inertial resistance, ∼2 s before the appropriate load was applied, and were verbally encouraged to continue pedaling as fast as possible throughout the 30‐s test. During the 1‐min recovery period between tests, they remained seated on the ergometer and either rested or were permitted to cycle at a low cadence (50 to 60 revolutions/rotations per minute) against a light resistance (~50 W) to reduce venous pooling in the lower extremities and minimize feelings of light‐headedness or nausea.Prior to test, the maximal heart rate was calculated as 220 minus age. The target exercise intensity for each individual was 90%–95% of the estimated maximal heart rate. Heart rate was monitored continuously during cycling using a wireless chest‐strap monitor (Polar A300, Polar, Denmark). Each interval and resistance was varied as needed to maintain the heart rate within a range of ±5 beats/min of the target heart rate. As shown in Figure | PMC9875746 |
Statistical analyses | Continuous variables are expressed as mean, least squares mean, standard deviation, standard error, or (25th–75th percentile value) where applicable, categorical variables as frequency and percentage. For each set of data, normal distribution was verified by a Shapiro–Wilk test. Differences in parameters between the resting versus SIT trial were analyzed for each time point using a two‐factor repeated‐measures ANOVA, and two‐sided Student's | PMC9875746 | ||
RESULTS | x‐axis | After an oral 75‐gram glucose challenge (60 min), the RQ increased from baseline and trial sequences (time effect Effect of resting or SIT protocol on metabolic outcomes during the fasting, postprandial, and exercise periods. Respiratory quotient (RQ, a), RQ total response [area under the curve (AUC)] for each group (b), Fat utilization (c), Fat total response [AUC)] for each group (d), Carbohydrate (CHO) utilization (e), CHO total response [AUC)] for each group (f), capillary blood glucose concentrations (g), capillary blood glucose concentrations total response [AUC)] for each group (h), capillary lactate concentrations (i), capillary lactate concentrations total response [AUC)] for each group (j). Fasting values correspond to the resting metabolic rate period, that is, before the 75‐g glucose load, while 60, 120, and 180 represent the time in minutes for gas exchange data after the 75‐g glucose intake. The soda cup icon (x‐axis) represents the moment in which the glucose (75‐g dose, postprandial glycemia PPG) was provided. The bike icon (x‐axis) represents the moment in which the exercise was started. All AUCs are presented mean (SD) except on the figures where data are plotted as least squares mean (SEM) for better clarity. a Differences with fasting; b differences with 75‐g dose PPG; and c differences with 60 min. ***The effect of SIT versus resting on substrate contributions was significant (The glucose time‐course responses are shown in Figure A significant decrease in both systolic and diastolic BP was observed (time effect Effect of resting or SIT trial on brachial blood pressure during the fasting, postprandial, and exercise period. Systolic blood pressure (BP, a), Systolic BP total response [area under the curve (AUC)] for each group (b), Diastolic BP (c), Diastolic BP total response [AUC)] for each group (d). Fasting values correspond to the resting metabolic rate period, that is, before the 75‐g glucose load, while 60, 120, and 180 represent the time in minutes for gas exchange data after the 75‐g glucose load. The soda cup icon (x‐axis) represents the moment in which the glucose (75‐g dose, postprandial glycemia PPG) was provided. The bike icon (x‐axis) represents the moment in which the exercise was provided. All AUCs are presented mean (SD) except on the figures where data are plotted as least squares mean (SEM) for better clarity. | PMC9875746 | |
DISCUSSION | obese, fatty liver diseases, SIT, high‐intensity, diabetes | OBESE, CVD, DYSLIPIDEMIA, HYPERTENSION, DIABETES | In the present study, we aimed to explore the effects of acute SIT on metabolic response and substrate utilization after an oral 75‐gram glucose load in individuals with overweight/obesity. We found that the fat contribution to energy expenditure and lactate levels significantly increased during the postprandial period after SIT, whereas the carbohydrate contribution was reduced. Moreover, the fat contribution and lactate concentration AUC were significantly higher in the SIT group than in the resting group, whereas the carbohydrate contribution AUC was lower. Furthermore, the RQ was lower in the SIT group than in the resting group at 120 min of the postprandial period and the RQ AUC was also lower in the SIT group. These results indicate that acute SIT may have positive effects on the metabolic response to postprandial glucose in adults with overweight/obesity.Exercise is well‐documented to increase fat oxidation, which is principally due to the decrease of re‐esterification (Ho et al., In addition to fats, it is known that carbohydrates are simultaneously oxidized during energy production (Spriet, Regarding RQ, which reflects substrate utilization when energy is expended, we found that while this metric increased at 60 min after a glucose load, it was significantly lower in the SIT group than in the control group at 120 min postprandial. Our findings confirm prior observations of differential RQ responses to exercise training, with high‐intensity exercise shown induce a greater reduction in RQ (Burgomaster et al., In the last decades the consumption of sugars in food and beverages has risen alarmingly and this is known to be associated with increased risk factors for CVD including dyslipidemia, hypertension, diabetes, or non‐alcoholic fatty liver diseases (Stanhope, The present study has some limitations that should be acknowledged. First, the study population comprised healthy overweight and obese adults that did not routinely participate in moderate‐ to high‐intensity aerobic exercise, and none had participated in resistance training in the last 3 month. As training status, sex and nutritional status of the individuals are determinants of metabolic response, our results may not be generalizable to other populations with different characteristics. Accordingly, these determining factors must be considered when interpreting results between studies. Second, the small sample size might be considered as a potential limitation, and future studies in larger cohorts including individuals with different characteristics (i.e., normal weight or physically active) are needed to further elucidate how acute SIT and metabolic responses are related. Third limitation is that we did not control the pre‐test nutritional habits of the participants, which could have affected metabolic responses. Future studies should examine whether diets high or low in carbohydrates or fats have a relevant effect on total oxidation rates of the substrates (Peric et al., The main strength of our study is that, to our knowledge, this is the first to investigate the effect of acute SIT on metabolic responses and substrate utilization after glucose consumption in inactive adults with overweight/obesity from the Latin‐American population. In addition, we provide measurements of these postprandial responses at multiple time points to better describe their temporal course.In conclusion, the present investigation indicates that acute SIT might have a positive effect on metabolic response to postprandial glucose and, therefore, it could be recommended for improving metabolism response in adults with overweight/obesity. The mechanism(s) involved in substrate utilization with SIT are not fully elucidated and the topic warrants further investigation. | PMC9875746 |
AUTHOR CONTRIBUTIONS | Robinson Ramírez‐Vélez | Hugo Alejandro Carrillo‐Arango, Mikel Izquierdo, and Robinson Ramírez‐Vélez conceived and designed study; Robinson Ramírez‐Vélez and Miguel Alejandro Atencio‐Osorio performed statistical analysis; Hugo Alejandro Carrillo‐Arango, Miguel Alejandro Atencio‐Osorio, and Robinson Ramírez‐Vélez experimental phase; all authors interpreted results of analysis; Carlos Alejandro López‐Álban and Edna J. Nava‐González prepared figures; Edna J. Nava‐González, María Correa‐Rodríguez, and Robinson Ramírez‐Vélez drafted manuscript; all authors edited and revised manuscript; all authors approved final version of manuscript. | PMC9875746 | |
FUNDING INFORMATION | DEL | The EXERMET study was supported by Universidad del Valle. They do not have influence or authority about collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. | PMC9875746 | |
CONFLICT OF INTEREST | No conflicts of interest, financial or otherwise, are declared by the authors. | PMC9875746 | ||
ETHICS STATEMENT | DEL | Participants were fully informed of the risks of the study and signed informed consent forms before any procedure. This study was approved by The Universdad del Valle Ethics Committee (ID number: 174–020 and 018–020, Cali, Colombia) and complied with the Declaration of Helsinki. | PMC9875746 | |
REFERENCES | PMC9875746 | |||
1. Introduction | collagen-induced, obese, overweight, platelet aggregation | SECONDARY, OBESE | These authors contributed equally to this work.Tomatoes are known for their numerous health benefits, including antioxidants, anti-cancer, antimicrobial, anti-inflammatory, anti-neurodegenerative, antiplatelet, and cardio-protective properties. However, their potential health benefits in the Mediterranean diet’s popular soffritto remain largely unexplored in scientific research. The objective was to evaluate the effects of soffritto intake on platelet activity, vascular endothelial function, weight, lipid profile, and blood parameters. In a prospective, controlled, randomized two-arm longitudinal cross-over trial, 40 overweight and obese individuals received 100 g/day of soffritto, or a control, for 42 days. The primary outcome was the effect on vascular endothelial function and platelet activity. As exploratory secondary outcomes, anthropometric measures, serum lipid profile, and hemogram profile were measured before and after a 6-week intervention with or without soffritto supplementation. Compared with the control group, soffritto supplementation for six weeks improved collagen-induced (−5.10 ± 3.06%) platelet aggregation (The occurrence of overweight and obesity is persistently rising in both developed and developing countries [Tomato, a staple of the Mediterranean diet, is an important source of antioxidants, mainly carotenoids (such as lycopene), phenolic compounds, and vitamins [Discrepancies in the beneficial health effect of tomato or tomato-based products consumption have been related to the bioavailability of lycopene, as it is higher in tomato paste than in fresh tomatoes [ | PMC10745891 |
2. Materials and Methods | PMC10745891 | |||
2.1. Subjects | Forty healthy adult men ( | PMC10745891 | ||
2.2. Ethics Statement | The entire participant signed an informed consent and was able to withdraw from the study at any time without giving a reason. This study received approval from the Human Ethical Review Committee of Hospital Santa Creu I Sant Pau (Barcelona, Spain), with the reference number 12/181 and the date of approval being 11 January 2013. | PMC10745891 | ||
2.3. Soffritto Samples | Soffritto samples were supplied by PREPARADOS ALIMENTICIOS S.A. and consisted of a cooked mix of tomato, onion, extra virgin olive oil, sugar, and salt (see details of product composition in | PMC10745891 | ||
2.4. Study Design and Dietary Monitoring | dizziness, vomiting, flushing, bloating, diarrhea | ADVERSE EFFECTS, BLOOD | The study carried out was a prospective, controlled, randomized two-arm longitudinal crossover trial [Clinical Trial: NCT06161883], performed in a single center, as indicated in After a run-in period of two weeks, the study was carried out for 14 weeks, including two sequential intervention periods (6 weeks each). In the first intervention period, participants were randomly separated into two different arms (During the duration of the study, the volunteers were asked to maintain their usual diet, excluding raw or cooked tomatoes as well as tomato-based products (sauces, ketchup, juices, etc.) other than those administered during the study in the corresponding periods. Dietary patterns, assessed using food frequency questionnaires, were documented before each visit, and minimal alterations in dietary habits were reported. Adherence was monitored through regular telephone communication with participants, coupled with interviews conducted at the conclusion of each intervention period. Volunteers also recorded whether they had consumed tomato or tomato-based products on a diary card each day. Additionally, a clinician evaluated potential side effects or symptoms, such as flushing, bloating, dizziness, vomiting, and diarrhea, which could be linked to soffritto intake, at the conclusion of each intervention period. However, no adverse effects were observed in the volunteers.Blood samples, obtained following a twelve-hour fasting period, were collected on days 1 and 42 to establish baseline and first treatment period endpoints. Similarly, blood samples were obtained on days 56 and 98, representing baseline and second treatment period endpoints ( | PMC10745891 |
2.5. Outcomes | SECONDARY | The primary outcome measure was the effect of soffritto intake on vascular endothelial function and platelet activity (arachidonic acid, collagen, and adenosine diphosphate (ADP)). The secondary outcome measures were anthropometric measurements, blood pressure, lipid profile, hepatic and renal markers, and blood parameters. | PMC10745891 | |
2.5.1. Platelet Aggregation | platelet aggregation | TRANSMISSION | The study of platelet function was performed by analyzing platelet aggregation induced by different agonists: arachidonic acid (1 mM), collagen (2 and 5 µM), and ADP (5 and 20 µM) by the light transmission technique LTA (“Light Transmission Aggregometry”) in platelet-rich plasma prepared within an interval of 30 min from blood withdrawal at the different time-points of the study. The preparation contained 250,000 platelets/µL of platelet-poor plasma from each individual that was used as a 100% light transmission control. The recording of platelet aggregation was performed for a period of 5 min and was used for the calculation of the maximum aggregation [ | PMC10745891 |
2.5.2. Flow Cytometric Analysis of Circulating Extracellular Vesicles | Three-label flow cytometry analysis was assessed as previously described by Suades et al. [Acquisition was performed at 1 min per sample at a low flow rate. Forward scatter (FSC), side scatter (SSC), and fluorescence data were acquired using settings configured on the logarithmic scale. Gate limits were established following the criteria previously described [Data was analyzed with the BD FACSDiva™ Software (version 6.1.3). The concentration (number of cEVs per µL of plasma) was determined according to Nieuwland’s procedure [ | PMC10745891 | ||
2.5.3. Anthropometric Data, Blood Pressure, Lipid Profile, and Other Biochemical Measurements | hepatic and renal markers | HYPERTRIGLYCERIDEMIA | Trained personnel performed the anthropometric and clinical measurements (height, weight, waist circumference [WC], and blood pressure). Anthropometric and blood pressure measurements were determined at baseline and at the end of the treatment, before the extraction of the blood sample. BMI was obtained by dividing the body weight in kilograms by the square of height in meters (kg/mRoutine commercially available assays were utilized for the assessment of serum biochemical measurements, encompassing glucose levels, hepatic and renal markers, hemograms, and the standard serum lipid profile. including triglycerides (TAG), total cholesterol, and high-density lipoprotein cholesterol (HDLc) (Roche Diagnostics, Basel, Switzerland). As there were no cases of hypertriglyceridemia, low-density lipoprotein cholesterol (LDLc) was calculated using the Friedewald equation. Glomerular filtration rate was obtained according to the CKD-EPI Levey equation [ | PMC10745891 |
2.5.4. Vascular Endothelial Function and Hemogram Profile | REACTIVE HYPEREMIA, PAT, ARTERIAL STIFFNESS | Endothelial function and blood parameters were assessed by digital plethysmography using the EndoPAT2000 device (Itamar Medical Ltd., Caesarea, Israel). Measurements were conducted following the guidelines provided by the manufacturer, with participants in a supine position, hands positioned at the same level, in a comfortable and thermoneutral environment at a temperature ranging from 21 to 24 °C. Arterial systolic and diastolic blood pressures were measured before starting the test. Pneumatic probes were placed on each index finger and a blood pressure cuff on one arm (study arm), while the contralateral arm served as a control (control arm). After a 10-min equilibration period, the blood pressure cuff on the study arm was inflated to 60 mmHg above systolic pressure for 5 min. The cuff was then deflated to induce reactive hyperemia, and the signals from both PAT channels (Probe 1 and Probe 2) were recorded by a computer. Occlusion was confirmed by the complete attenuation of the PAT signal from the test arm. To correct for systemic changes in vascular tone, recordings from the non-occluded arm (internal control) were used. The EndoPAT software package (version 3.4.4) was used to calculate endothelial function and arterial stiffness. Endothelial function was given as the reactive hyperemia index (RHI) and arterial stiffness as the augmentation index (AI), with AI standardized to a pulse of 75/min (AI@75) [ | PMC10745891 | |
2.6. Statistical Analysis | Statistical analyses were conducted using STATA 15 (College Station, TX, USA) software. The data are expressed as the mean and the standard error of the mean. The normality of the distribution was assessed using the Shapiro–Wilk test. To assess statistical baseline differences between groups, a paired Student’s | PMC10745891 | ||
3. Results | ADVERSE EFFECTS | The prospective, two-arm longitudinal crossover design, including enrollment, the randomization scheme, and final sample distributions by treatment group, are presented in the Consolidated Standards of Reporting Trials (CONSORT) diagram (The study was carried out in a group of 40 individuals (13 women and 27 men) with an average age of 40.8 ± 1.3 years. The entire study population completed both treatment phases, and no adverse effects were observed during the consumption of the tomato products. Adherence to the study dietary pattern was >97% during the 6 weeks of the intervention period. During the duration of the study, the volunteers were asked to maintain their usual diet, excluding raw or cooked tomatoes as well as tomato-based products (sauces, ketchup, juices, etc.) other than those administered during the study in the corresponding periods. Eighty-five percent of the individuals declared to have followed the indicated instructions, and 15% reported to have taken sporadically tomato or ketchup (4–8% of the days) within the usual range of a daily diet, irrespectively of the intervention stage (wash-out period, control, or soffritto intervention period). Therefore, all the individuals were included in the statistical study. | PMC10745891 | |
3.1. Platelet Function | collagen-induced, platelet aggregation | As for platelet activity, the comparison between changes (effect of intervention—baseline) observed in the soffritto and control groups is presented in Given the significant decrease in collagen-induced platelet aggregation, the differences between baseline and final levels were analyzed; however, no statistically significant difference was observed ( | PMC10745891 | |
3.2. Endothelial Function | ADHESION | Regarding endothelial function (RHI, lnRHI, FRHI, and AI@75), the analysis of baseline characteristics indicated that both intervention groups presented a similar endothelial function (The analysis of the differences observed between the beginning and the end of each of the interventions showed that the effect was similar in both groups in all the parameters analyzed (cEVs carrying E-selectin (CD62E) and the cell adhesion molecule MUC-18 (CD146), released by activated endothelium, are found in very low quantities in comparison to the total amount of cEVs found in our study population (<0.5% of total cEV number) ( | PMC10745891 | |
3.3. Anthropometric and Biochemical Variables | Baseline characteristics of the population after run-in (period 1) and wash-out (period 2) are depicted in The effect of a six-week soffritto intake is presented in | PMC10745891 | ||
3.4. Lipid Profile | Analysis of the baseline blood lipid profile characteristics revealed that both groups presented a similar profile in TC, HDLc, LDLc, non-HDLc, LDLc/HDLc ratio, and TAG (The daily intake of soffritto preparation during a period of six weeks did not induce any significant changes in the levels of TC, TAG, and cholesterol transported by HDL, LDL, and non-LDL (Furthermore, the impact of daily consumption of soffritto on blood lipids was examined, considering factors such as age, BMI, or sex (analyzed through Spearman correlation). However, no statistically significant differences were noted, as depicted in | PMC10745891 | ||
3.5. Blood Parameters | Regarding hemoglobin, red and white blood cells, and platelets, no statistically significant differences were observed between the two groups at baseline (Analysis of the differences observed after six weeks of daily intake of soffritto or in the control group showed that there were no statistically significant differences between the two groups in all the variables previously mentioned after six weeks ( | PMC10745891 | ||
4. Discussion | obesity, obese, overweight, overweight or obesity, atherosclerosis, platelet aggregation | CVD, OBESITY, ATHEROSCLEROSIS, OBESE | The beneficial effect of fresh tomatoes or their derivatives (e.g., purée, sauces, ketchup) in reducing conventional CVD risk markers has been deeply studied in the last few decades [Regarding our main outcome, platelet activity, so far it is well known that platelet activation is triggered by several intracellular signaling cascades stimulated by different soluble agonists such as ADP, collagen, and arachidonic acid, among others. Collagen induces platelet aggregation by triggering granule secretion through glycoprotein VI (GPVI) and proteinase-activated receptor signaling. ADP induces platelet activation that mediates the P2Y12 or P2Y1 receptor-signaling pathway [To date, scientific evidence of the beneficial effects of tomato-base products on CVD and platelet aggregation has been demonstrated in in vitro [Based on our obtained results, it can be extrapolated that the consumption of soffritto among overweight and obese individuals does not exhibit any discernible negative influence on endothelial function, as demonstrated by measuring the vascular resistance to hyperemic conditions and the release of eEVs containing markers of activated endothelial cells. This is important, as endothelial function is one of the most reliable markers of vascular health, and its deterioration is considered the common pathway linking coronary risk factors to the progression of atherosclerosis [Another of the findings of our study was that the daily intake of soffritto during the six weeks did not affect any of the anthropometric variables or biochemical profiles of overweight and obese individuals. In a study carried out in 2013, four weeks of regular consumption of high-lycopene sauce or commercial sauce did not induce changes in anthropometrical and biochemical variables (weight, BMI, WC, insulin, glucose, and uric acid) in a healthy population [One additional finding in our study is that the daily intake of soffritto preparation does not induce changes in the serum lipid profile in individuals with overweight or obesity. In the study carried out by García-Alonso et al. (2012) [This study faced several limitations, primarily related to the sample size. Consequently, further investigation with a larger sample size is needed to validate the vascular and platelet effects associated with the intake of soffritto in overweight and obese individuals. Another of the limitations of our study lies in the fact that the participants enrolled in this trial, despite being overweight or obese, may have been in generally good health, which could have made it difficult to identify significant changes in CVD risk markers. Therefore, the inclusion of volunteers with CVD risk factors and/or a higher BMI (obesity class II) could have increased the likelihood of detecting changes. | PMC10745891 |
5. Conclusions | obese, overweight, platelet aggregation, thrombotic | CVD, EVENTS, OBESE, ARTERIAL STIFFNESS | The remarkable health benefits of tomatoes are widely acknowledged, boasting an impressive array of properties due to their antioxidants, vitamins, glycoalkaloids, and minerals. Surprisingly, although soffritto is a staple in the Mediterranean diet, its potential health effects remain largely uncharted territory in scientific research. Soffritto, being cooked tomatoes, has increased antioxidant properties, but whether its additional components had any unwanted effects was unknown.The present study suggests that the consumption of soffritto resulted in a reduction in platelet aggregation after a six-week period in overweight and obese subjects. The observed effects were more evident in collagen and ADP-induced platelet aggregation. No significant effects of the soffritto intake were observed for anthropometric measures, serum lipid profile, vascular endothelial function, or arterial stiffness. We conclude that the intake of tomato soffritto in overweight and obese subjects is safe and may have a role in the primary prevention of CVD by reducing platelet activation, which could contribute to a reduction in thrombotic events. | PMC10745891 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10745891 | ||
Author Contributions | Conceptualization, T.P., G.V. and L.B.; methodology, T.P., G.V., A.P. and L.B.; formal analysis, T.P., G.V. and L.B.; investigation, T.P., G.V. and L.B.; data curation, A.L.-Y., T.P., V.d.S.V., N.M.-G., A.P. and L.B.; writing—original draft preparation, A.L.-Y., T.P. and L.B.; writing—review and editing, A.L.-Y., T.P. and L.B.; visualization, A.L.-Y., T.P., V.d.S.V., N.M.-G. and L.B.; supervision, A.L.-Y., T.P. and L.B.; project administration, T.P., G.V. and L.B.; funding acquisition, T.P., G.V. and L.B. All authors have read and agreed to the published version of the manuscript. | PMC10745891 | ||
Institutional Review Board Statement | Approval for this study was granted by the Human Ethical Review Committee of Hospital Santa Creu I Sant Pau (Barcelona) under reference number 12/181, with the approval date recorded as 11 January 2013. | PMC10745891 | ||
Informed Consent Statement | All participants provided written consent after being adequately informed before their inclusion. | PMC10745891 | ||
Data Availability Statement | The information outlined in the manuscript, as well as the code book and analytic code, will be provided upon a reasonable request, subject to scientific approval. | PMC10745891 | ||
Conflicts of Interest | L.B. declares to have served as an SAB member of Sanofi, Ionnis, Pfizer, and NovoNordisk; to have received a research grant from AstraZeneca; to have received speaker fees from Sanofi and Bayer; and to have founded the Spin-Offs Glycardial Diagnostics SL and Ivastatin Therapeutics S (which are not associated with this research). T.P. discloses being a co-founder of Spin-offs Glycardial Diagnostics SL and Ivastatin Therapeutics S (both unrelated to this study). The remaining authors have no competing interest to declare. | PMC10745891 | ||
References | collagen-induced, platelet aggregation | REACTIVE HYPEREMIA | Flow diagram describing the study design.Differences in the change of platelet function between groups after six weeks of intervention (soffritto and control). * indicates a significant statistical difference (Comparison between baseline and final values for collagen-induced platelet aggregation (2 µM) and ADP-induced platelet aggregation (20 µM) after six weeks. * Indicates a significant statistical difference (Soffritto composition.Endothelial function at baseline and changes observed after 6 weeks in the control group and in the soffritto group.RHI: reactive hyperemia index; lnRHI: logarithm of RHI; FRHI: Framingham RHI; AI@75: augmentation index standardized to a pulse of 75/min. Data are expressed as mean ± SEM. Differences at baseline and in the effect of treatment between groups were analyzed by a paired Student’s Obesity-related variables and serum lipid levels at baseline and changes after a 6-week dietary intervention without (control) or with soffritto.ALT: alanine transaminase; AST: aspartate transaminase; BMI: body mass index; DBP: diastolic blood pressure; GGT: gamma-glutamyltransferase; SBP: systolic blood pressure; TAG: triacylglycerols; TC: total cholesterol; WC: waist circumference; WtHR: waist-to-height ratio. Data are expressed as mean ± SEM. Differences in the baseline values between groups were analyzed by a paired Student’s | PMC10745891 |
ABSTRACT | PMC10662626 | |||
Objective | skeletal muscle dysfunction | CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Exercise training is a cornerstone of the treatment of chronic obstructive pulmonary disease, whereas the related interindividual heterogeneity in skeletal muscle dysfunction and adaptations are not yet fully understood. We set out to investigate the effects of exercise training and supplemental oxygen on functional and structural peripheral muscle adaptation. | PMC10662626 |
Methods | quadriceps femoris muscle | In this prospective, randomized, controlled, double-blind study, 28 patients with nonhypoxemic chronic obstructive pulmonary disease (forced expiratory volume in 1 second, 45.92% ± 9.06%) performed 6 wk of combined endurance and strength training, three times a week while breathing either supplemental oxygen or medical air. The impact on exercise capacity, muscle strength, and quadriceps femoris muscle cross-sectional area (CSA) was assessed by maximal cardiopulmonary exercise testing, 10-repetition maximum strength test of knee extension, and magnetic resonance imaging, respectively. | PMC10662626 | |
Results | After exercise training, patients demonstrated a significant increase in functional capacity, aerobic capacity, exercise tolerance, quadriceps muscle strength, and bilateral CSA. Supplemental oxygen affected significantly the training impact on peak work rate when compared with medical air (+0.20 ± 0.03 vs +0.12 ± 0.03 W·kg | PMC10662626 | ||
Conclusions | heterogenous, hypoxia, muscle dysfunction | HYPOXIA | The heterogenous functional and structural muscle adaptations seem determined by supplemental oxygen and exercise-induced hypoxia. Indeed, supplemental oxygen may facilitate muscular training adaptations, particularly in limb muscle dysfunction, thereby contributing to the enhanced training responses on maximal aerobic and functional capacity. | PMC10662626 |
Key Words | peripheral muscle, COPD | CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD | Physical exercise training is recommended in all international guidelines on chronic obstructive pulmonary disease (COPD), being an evidence-based central therapeutic measure for these patients (It remains unresolved whether nonhypoxemic COPD patients should exercise with supplemental oxygen (Because supplemental oxygen is known to reduce ventilatory limitation, thereby improving exercise tolerance (In this study, we set out to investigate whether exercise training and supplemental oxygen affect peripheral muscle adaptation, which incorporates important prognostic markers for this population. This is the first training intervention study in patients with COPD, which aims to assess the impact of supplemental oxygen, providing parallel analyses on muscle function and mass evaluated by MRI. | PMC10662626 |
MATERIALS AND METHODS | exacerbations | COLD | The Flow diagram. Fifty of 137 contacted patients met the eligibility criteria and entered the training-free run-in period. At training start, allocation concealment was ensured by an external block randomization for group allocation and concealed medical gas sources by locked away gas cylinders; a hidden gas distributing system was provided from the gas supplier. Although 16 patients could not be evaluated after the training intervention, no differences in dropout rates were observed between both samples. Only two patients opted out during the training period, at a very early stage of the intervention. Other withdrawals were because of comorbidities, exacerbations during the cold winter months, and no available MRI data. The exercise training intervention was conducted at the University Institute of Sports Medicine, Prevention and Rehabilitation of the Paracelsus Medical University of Salzburg (Austria). | PMC10662626 |
Exercise training intervention | Patients performed 6 wk of combined endurance and strength training three times a week with either supplemental oxygen or medical air during training. Each endurance training session included 5-min warm-up (flow via nasal cannula, 4 L·min | PMC10662626 | ||
Functional evaluation | Quadriceps femoris muscle | Functional and aerobic capacity were assessed by ECG-monitored, incremental cardiopulmonary exercise testing (without oxygen supply) using Jaeger Hardware, analyzed with the JLAB Software on a stationary cycle ergometer (Ergoline Ergoselect 200) (Quadriceps femoris muscle strength was contemporaneously assessed by a standardized 10-repetition maximum (10-RM) strength test of knee extension with Proxomed® compass weight lifting machines. The 10-RM refers to the weight with which the patient was able to perform no more than 10 repetitions. | PMC10662626 | |
Muscle cross-sectional area | quadriceps femoris muscle | BEST | The main outcome of this investigation was the quadriceps femoris muscle cross-sectional area (CSA), assessed by MRI data sets acquired with a 3.0-T scanner (Achieva; Phillips-Medical-Systems, Best, the Netherlands). A T1-weighted turbo-spin-echo sequence (echo time, 15 ms; section thickness, 10 mm; in-plane resolution, 0.78 mmMuscle segmentation in MR images before and after training intervention. T1-weighted MR images with segmentation of the quadriceps femoris muscle (patient’s right side in purple and left side in pink) at baseline (a; top) and after the exercise training intervention (b; bottom). The femur, fatty, and connective tissues as well as vessels were excluded from the segmentation, but fascia lata and beginning rectus tendon were included. This technique and the slice-selection have been shown to adequately represent changes in extensor muscle volume ( | PMC10662626 |
Statistical analysis | A statistician has been involved in study design and outcome analyses. The Shapiro–Wilk test has been used to test for normality. For normally distributed data, unpaired | PMC10662626 | ||
RESULTS | COPD | COPD | This study analysis finally evaluated 28 patients aged 63.64 ± 5.97 yr with stable COPD and a mean FEVBaseline characteristics.This table shows the patients’ baseline characteristics at rest and at peak exercise measured at training start. Data are presented as mean and SD.BMI, body mass index; BP, blood pressure; Breathing reserve, based on a calculated maximal voluntary ventilation from resting FEV | PMC10662626 |
Effects of exercise training | Six weeks of exercise training led to a significant increase in functional capacity (peak work rate: 85.3 ± 6.0 vs 97.3 ± 6.2 W, | PMC10662626 | ||
Effects of supplemental oxygen | Although both study groups significantly improved their maximal exercise capacity, when both breathing conditions were compared after 6 wk of exercise intervention, it was observed that supplemental oxygen positively affected peak work rate when compared with medical air (differences: O | PMC10662626 | ||
Impact of exercise-induced peripheral desaturation | Although those patients who did not desaturate during exercise were able to significantly increase their total quadriceps femoris CSA during the training intervention (+4.0 ± 1.4 cm | PMC10662626 | ||
Subgroup analyses | quadriceps femoris muscle, quadriceps femoris muscle CSA, desaturation, quadriceps femoris muscle CSA.This | The impact of supplemental oxygen and exercise-induced peripheral desaturation led to different adaptations of total quadriceps femoris CSA between the respective subgroups (Table Impact of exercise training on quadriceps femoris muscle CSA.This table shows that, although patients’ total CSA (in centimeters squared) of their quadriceps femoris muscle has increased during the exercise training intervention, the impact was found statistically significant different when subgroups were compared with a one-way analysis of variance (*Subgroup comparisons of exercise capacity and CSA. The changes (Δ) of peak work rate (in watts) and quadriceps femoris muscle CSA (in centimeters squared) are presented in panels a and b, respectively. Functional and structural adaptation showed both similar training responses in the different subgroups.Impact of supplemental oxygen on training adaptations in desaturating patients. The impact of supplemental oxygen on patients with exercise-induced peripheral desaturation significantly affected the training adaptations on quadriceps femoris CSA (ΔCSA [in centimeters squared]) related to the respective peak work rate (Δ [in watts]).Correlations of structural with functional parameters of exercise capacity.This table provides an overview on how the changes of total CSA (quadriceps femoris muscle) during the training intervention are correlated with the impact on functional capacity, aerobic capacity, muscle strength, and exercise tolerance. Pearson’s correlation coefficient is provided for all variables.*** | PMC10662626 | |
DISCUSSION | quadriceps femoris muscle CSA, muscle gain, peripheral muscle, hypoxia, Peripheral muscle fatigue, muscle dysfunction, nonhypoxemic COPD, COPD | HYPOXIA, COPD | To the best of our knowledge, this is the first study to investigate the impact of an exercise training intervention with and without supplemental oxygen on independently assessed end points of functional and structural peripheral muscle adaptations in patients with nonhypoxemic COPD. The innovative assessment of the quadriceps femoris muscle CSA by MRI provides new insights into the training adaptations during pulmonary rehabilitation. In this population, limb muscle dysfunction and the related interindividual variability in the effects of exercise training on skeletal muscles are not yet fully understood. The main results of this investigation suggest the following interpretations:Peripheral functional and structural training adaptations are highly variable in this population.Supplemental oxygen increases the impact of exercise training on peak work rate and skeletal muscle mass.Peripheral muscle fatigue and hypoxia during exercise may affect the training response on muscle gain.Exercise-induced intermittent hypoxia might be a determinant to further investigate regarding its association with limb muscle dysfunction in COPD. | PMC10662626 |
Impact of exercise training and supplemental oxygen | Exercise training led to a significant increase in functional capacity, aerobic capacity, and exercise tolerance. Furthermore, a gain in muscle strength of knee extension has been shown after the training intervention. Data also suggest an important role of supplemental oxygen during exercise training, which significantly increased the functional training effects on peak exercise intensities ( | PMC10662626 | ||
Peripheral muscular training adaptation | peripheral muscular, COPD | COPD | This study provides additional value in evaluating the impact of supplemental oxygen during training in patients with COPD, because the previously discussed functional improvements on exercise capacity were associated with independently obtained parameters of peripheral muscular training adaptation ( | PMC10662626 |
Limb muscle dysfunction in COPD | muscle dysfunction, COPD | COPD | The interindividual heterogeneity regarding muscle dysfunction, weakness, and adaptation in these patients led to the concept that an unexpected limb muscle dysfunction phenotype may exist in COPD ( | PMC10662626 |
Limitations and perspectives | A limitation of this study is that MRI repetition and acquisition times varied because of software updates of the scanner in between. However, it has been shown that different turbo-spin-echo sequences, acquired at different scanners, and even with different echo times will yield highly reproducible shape parameters ( | PMC10662626 | ||
CONCLUSIONS | muscle gain, quadriceps femoris muscle, hypoxia, muscle dysfunction, nonhypoxemic COPD, COPD | COPD, HYPOXIA | To the best of our knowledge, this is the first randomized, controlled, double-blind trial to provide an evaluation of functional and morphological adaptations of thigh muscles after an exercise intervention with and without supplemental oxygen during training in patients with COPD. Supplemental oxygen significantly increased the training impact on peak work rate and fostered quadriceps femoris muscle growth. Our data may generate the hypothesis that exercise-induced peripheral hypoxia limits muscular training adaptations, which might, at least partially, explain the high interindividual variability, supporting the concept of a possible limb muscle dysfunction phenotype in COPD. However, this could be mitigated by providing supplemental oxygen during exercise training, which demonstrated great importance to ensure muscle gain and thus improve peak exercise capacity. Although the current evidence for providing supplemental oxygen during training for patients with nonhypoxemic COPD is limited, future studies should not anymore focus on the yes or no, but they may aim to understand when, how, and in which patients it could be best used.The authors thank the staff, collaborators, and technicians of the different involved institutions for their contribution and valuable support during study conduct.The The results of this study are presented clearly, honestly and without fabrication, falsification, or inappropriate data manipulation. The results of the present study do not constitute endorsement by the American College of Sports Medicine.Availability of data and material: Data are available on motivated request from the authors.Ethics approval: The ethics committee of the State of Salzburg approved the SCOPE study, which was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.Consent to participate: All participants provided written informed consent.Consent for publication: n.a.Code availability: n.a.Author contributions: D. Neunhäuserer was involved in study design, data acquisition, analysis, and interpretation, as well as in writing the article. M. H. was involved in data acquisition/interpretation, article writing, and revisions. D. Niederseer was involved in study design/conduct, and particularly as expert consultant, as well as in article revisions. M. V. was particularly involved in data interpretation, and literature and article revisions. W. W. was involved in data acquisition and article revisions. E. S.-K. was involved in study coordination/conduct and data acquisition. B. K. was involved in statistical study analyses, data interpretation, and article revisions. B. L. was involved in study design, data acquisition, and article revisions. A. E. was particularly involved as expert consultant and in data and article revisions. M. S. was involved in study design, data analysis, interpretation, and revision of the article. J. N. was involved in study design, data analysis and interpretation, and writing and revision of the article. All authors meet the criteria for authorship and read and approved the final version. | PMC10662626 |
REFERENCES | PMC10662626 | |||
1. Introduction | hyperglycemia, Type 2 diabetes, weight loss, T2D | HYPERGLYCEMIA, TYPE 2 DIABETES, TYPE 2 DIABETES | Type 2 diabetes (T2D) can be prevented or postponed by lifestyle modifications as shown by previous intervention studies. In most of these studies, participants have received resource-demanding individual counseling. In the 3-year T2D-GENE trial with lifestyle intervention, we investigated whether a less resource-demanding form of group and internet-based counseling is feasible and effective in preventing T2D in people with an increased risk for T2D. Altogether, 628 middle-aged to elderly men either with a high number or low number of T2D risk alleles were recruited. Five to seven group sessions were organized during the intervention, in addition to information and activities delivered via the web portal, and weekly monitoring of body weight and physical activity. Four-day food records with personal feedback were documented five times during the study. Of the 549 participants completing the study, over 90% participated in the group sessions and kept the food records. The four self-feedback tasks delivered during the second and the third years of the study were completed by 80–89% of the participants. In conclusion, a group and web portal-based lifestyle intervention is applicable for middle-aged to elderly men as a lifestyle modification aiming to prevent T2D.Previous studies have shown that type 2 diabetes (T2D) can be prevented or postponed by lifestyle modifications, i.e., a health promoting diet, weight loss, and regular physical activity [Genome-wide association studies have identified >400 common variants for T2D with small effect sizes, i.e., the risk of T2D is increased by 5–40% [In the T2D-GENE Trial, the primary aim was to compare the effect of lifestyle intervention (diet and physical activity emphasized) on the prevention of T2D and the worsening of hyperglycemia in people with a high number of T2D risk alleles compared with people with a low number of T2D risk alleles. Importantly, we also aimed to investigate whether a less resource-demanding form of group and internet-based counseling is as effective as individual counseling in preventing T2D in people with increased risk for T2D. The protocol of the T2D-GENE study has been previously described [ | PMC10097002 |
2. Materials and Methods | weight loss, Metabolic Syndrome | HEART, METABOLIC SYNDROME | Altogether, 628 men were recruited from the Metabolic Syndrome in Men (METSIM) study as previously described [Participants in the intervention groups had four visits with laboratory samples (0, 1, 2 and 3 years) as previously described [Group session 2 included dietary fiber intake, consumption of fruits, vegetables, and berries, and intake of salt and sugar. Group session 3 included the quality of dietary fat, protein intake, meal pattern, and physical activity. Optimal dietary choices were presented from food groups, e.g., cereal products, dairy products, meat products, and dietary fats and oils. Those participants whose BMI was >28 kg/mAt 1- and 2-year group sessions, the participants were further motivated for lifestyle modifications, and the principles of a health-promoting diet and physical activity were repeated. Furthermore, new optimal choices on the market for a health-promoting diet were presented.The spouses of the participants were welcome to all group sessions. Of the spouses, 30% participated in the motivation session and 16–22% in sessions 2 and 3. In weight loss sessions, the participation rate of the spouses was 14–15%. At the 1-year session, the participation rate of the spouses was 8%, and at the 2-year session it was 12%. Each session lasted about 90 min. The schedule, topics, and sizes of the groups are presented in Four-day food records were collected at baseline and at 6, 12, 24, and 36 months for dietary intake calculations (AivoDiet software, version 2.2.0.0, Mashie FoodTech Solutions Finland, Turku, Finland). Four-day food records were checked face-to-face upon being returned; these were checked by clinical nutritionists at all other time points except for at 6 months, when food records were collected via web portal or by mail and checked by phone. Each participant was given written detailed feedback on the results of the calculations, and, if needed, detailed tips were given to ensure participants were making optimal choices and reaching the aims set for dietary intake.The participants were invited to use the web portal designed for the study. They reported their body weight and physical activity weekly via the web portal. Manual recording was possible for those participants who did not have access to the internet. Physical activity was reported in three categories, i.e., light, moderate, or heavy activity. The goal was brisk walking or other types of exercise with comparable intensity a minimum of 30 min per day at least five days a week.The participants were also encouraged to fill simple, nationally-available questionnaires estimating their fiber intake, quality of dietary fat, and salt intake. Questionnaires on salt intake and quality of dietary fat were created by the Finnish Heart Association and the fiber test was modified from the version originally developed by the Finnish Bread Information Association (a general information service of bread business). The results were registered in the web portal, where the participants were able to follow their scores during the study (There was also a discussion forum in the web portal, where the participants could present questions, comments, and obtain answers from the clinical nutritionists throughout the intervention.Participants were contacted by the researchers monthly to provide information on health-promoting food choices and physical activity. In the materials, regarding the intake of certain food groups, e.g., fruits, some recipes suitable for a health-promoting diet were also included in the material provided. The topics of the monthly material are presented in During the second and the third years of the study, the participants were provided with four self-feedback tasks on the website. The topics were the following: dietary fiber, quality of dietary fat and sugar at 16 months, liquids and quality of fat at 20 months, dietary fiber at 28 months, and intake of fruits, vegetables, and berries at 32 months (The participants were encouraged to contact the researchers anytime they had questions or concerns for virtual discussion with the clinical nutritionists. With those who did not have access to the internet, a phone was used for communication (phone calls and SMS). | PMC10097002 |
3. Results | T2D, weight loss, illness | The 3-year intervention was completed by 549 participants. Of 628 participants who started the intervention, 26 developed T2D before the 3-year study visit and 53 discontinued the intervention due to, e.g., illness requiring treatment, or work-related limited time resources. The participation percentage in the group meetings among all participants was 92.0–99.5%. About 55% of the participants attended also the group meetings focusing on weight loss, which were primarily provided for those having a BMI over 28 kg/mWhen the participants started, 97.6–99.5% of the participants completed the food records, whereas at the 6-month time point, the corresponding percentage was 92.6%.There were altogether over 51,000 logins to the web portal during the study, and 533 of the participants used the web portal at least once during the study. The web portal was used most actively during the first study year and there were peaks in the use close to the study visits, when food records were collected and when participants were asked to complete the tests for fiber intake, quality of dietary fat, and intake of salt in the web portal. The web portal activity is shown in Altogether, 560 participants recorded body weight and physical activity at least once during the intervention, either using the web portal or a written form (During the second and the third intervention years, the four self-feedback tasks provided on the website or via mail ( | PMC10097002 | |
4. Discussion | T2D, eating behavior | A group and web portal-based lifestyle counseling intervention was very well welcomed by the participants based on their activity in participating in the group sessions, returning the food records, recording body weight and physical activity, and completing the tasks during the second and third years of the study, as well as through the login details on the website designed for the study.The combination of dietary modification and physical activity has been shown to be an effective combination for T2D prevention [In the present study, the main emphasis was on both the quality of the diet and physical activity. In addition, healthy body weight, eating behavior, and alcohol intake were discussed in the group sessions. Zhang and coworkers [There are only a few studies reporting the results of a group-based intervention aimed at lifestyle changes. Pletsch-Borba and coworkers [One issue to be considered in dietary counseling is the profession of the healthcare professionals in charge of counseling. In the present study, clinical nutritionists designed the information provided in group sessions and via the web portal, as well as the tasks provided during the intervention. In an SRMA by Möller at al. [New approaches for the prevention of T2D are needed to manage the huge burden the healthcare system is facing due to the increasing number of individuals at risk for T2D. In addition to the high-risk strategy, population-based strategies are also warranted for the prevention of T2D. Distant counseling approaches might be useful also for lower income countries due to their lesser demand for financial resources. The approach used in the T2D-GENE trial retained the activity level among the majority of participants during the whole 3-year intervention and provided ideas for less resource-demanding actions for the healthcare system to meet the challenge of preventing T2D. | PMC10097002 | |
5. Conclusions | T2D | In conclusion, a group and web portal-based lifestyle intervention is applicable for middle-aged to elderly men as a lifestyle modification aiming to prevent T2D. | PMC10097002 | |
Author Contributions | Conceptualization, U.S., M.L. (Maria Lankinen) and M.L. (Markku Laakso); methodology, U.S., M.L. (Maria Lankinen), M.U. and M.L. (Markku Laakso); writing—original draft preparation, U.S. and M.L. (Maria Lankinen); writing—review and editing, M.U. and M.L. (Markku Laakso); visualization, M.L. (Maria Lankinen); supervision, M.L. (Markku Laakso); project administration, M.L. (Markku Laakso); funding acquisition, U.S. and M.L. (Markku Laakso). All authors have read and agreed to the published version of the manuscript. | PMC10097002 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee of the Hospital District of Northern Savo (71/2016, date of approval 9 February 2016). | PMC10097002 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10097002 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy and ethical restrictions. | PMC10097002 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10097002 | ||
References | nutrients/foods | COLD | Examples of the results of the questionnaires filled by the participants on the web portal estimating their fiber intake, quality of dietary fat, and salt intake. The scores they obtained from the questionnaires were shown as these kinds of bar charts in the web portal. The colors illustrated whether their intake was optimal (green), fair (yellow and orange), or non-optimal (red).Self-feedback tasks during the second and the third years of the study. The participants indicated their typical food choices and tested what the effect is on their nutrient intake if they change their choices. The first task (month 16) included, e.g., choices of bread, spreads, and cold cuts, ingredients in fish soup, or coffee bread. The second task (month 20) compared sugar, fat, and energy content in different liquids. The third task (month 28) demonstrated the effect of choices in grains, vegetables, fruits, berries, nuts, and seeds on fiber intake. The fourth task (month 32) dealt with the intake of vegetables, fruits, and berries. Metrics indicated the amount of nutrients/foods, and colors illustrated whether the amount was optimal (green), fair (yellow and orange), or non-optimal (red).(Timing, topics, and participation rates of the group meetings.Topics of the monthly materials. | PMC10097002 |
Methods | tooth brushing behavior, abortion | This study was a randomized controlled trial conducted on expectant mothers visiting the health centers of Arak from February to November 2022. It received approval from the Ethics Committee of Hamedan University of Medical Sciences (IR.UMSHA.REC.1399.863). In addition, this study has been approved by the Iranian Registry of Clinical Trials (identifier: IRCT20221228056955N1; For sampling, health centers were divided according to the five districts of the municipality. Based on the size and population of each district, a few centers in each district were chosen at random (39 centers out of 50). The selected centers were randomly allocated to control (20 centers) and intervention (19 centers) groups. Eventually, the samples from each center were extracted from the Sib system via simple random sampling. Initially, 174 people were assessed to participate in the study. Nonetheless, 38 people did not meet the inclusion criteria, and 5 people were not interested in participating in the study. Moreover, 21 people did not complete the questionnaire at baseline. Accordingly, 110 people entered the study and were randomly allocated to two intervention and control groups )55 people in each group). During the study, four people in the control group (abortion = 2 and leave the group = 2) and one person in the intervention group (abortion = 1) were excluded from the study. Therefore, 54 people in the intervention group and 51 people in the control group remained for analysis (
Flowchart of Participants and Group Allocations In the present study, the data collection tool was the questionnaire used in the study by Bashirian et al, whose validity and reliability have been measured previously. The needs assessment and development of the educational program regarding the determinants of tooth brushing behavior in pregnant women were conducted based on the findings of a previous descriptive study. Before the beginning of the educational intervention, the pre-test was completed by both groups. Then, the educational program based on HPM was implemented for the intervention group through the social media application WhatsApp in the form of 9 sessions. The objectives of each session were to influence one of the constructs of the HPM. | PMC10422136 | |
Educational programs to improve the frequency and duration of brushing in pregnant women
| tooth brushing (Secondary outcomes). | BLIND | The outcomes of the study included the constructs of Pender’s HPM (Primary outcomes), as well as the brushing frequency and duration of tooth brushing (Secondary outcomes). Owing to the nature of the study, we could not blind the instructor with regard to the groups, but blinding was considered for the participants, and therefore, this research was a single-blind study. The obtained data were analyzed using SPSS software (version 18) via descriptive and inferential statistics (independent | PMC10422136 |
Results | ± | The mean age in the intervention and control groups was 28.16 ± 5.64 and 28.90 ± 5.52 years, respectively, and the difference was not statistically significant ( | PMC10422136 | |
Comparing control and intervention groups in terms of demographic characteristics
| PMC10422136 | |||
Comparison of HPM constructs and behavior before and three months after the intervention in the intervention and control groups
| PMC10422136 | |||
Behavior in the intervention and control groups before and after the intervention
| PMC10422136 | |||
Discussion | tooth brushing behavior, tooth | This study sought to evaluate the impact of an educational program according to the HPM on brushing behavior in pregnant women. HPM-based training enhanced the duration of tooth brushing behavior in the intervention group compared to the control group in the present study. However, there was no change in the frequency of tooth brushing. The results of some studies revealed improvements in preventive oral hygiene behaviors, The findings of this study indicated that three months after the intervention, the perceived benefits of tooth brushing behavior were enhanced in the intervention group in comparison with the control group. These findings are in agreement with those of the study by Anderson et al, Moreover, the results of this study demonstrated that three months after the intervention, the perceived barriers associated with tooth brushing behavior were considerably lower in the intervention group than in the control group. These findings are in line with those of similar studies. An additional finding of this study was that positive affect cues to behavior were promoted, while negative affect cues to behavior were reduced in the intervention group compared to the control group. These results are in agreement with those of the study by Dehdari et al Some of the strengths of this study were the utilization of virtual education and the appropriate time and location for each individual. However, one of the study’s limitations was the assessment of behavior via self-report. Another constraint was that the pregnant woman’s attention was preoccupied with various matters linked to the health of the mother and the fetus throughout pregnancy, which might have affected the degree of involvement in group discussions about oral health. To modify this problem, telephone calls were used to increase mothers’ motivation to participate in group activities. | PMC10422136 | |
Highlights | tooth brushing frequency | Brushing time for 2-3 minutes in the intervention group increased from 51.85% to 75.92% after the intervention. The tooth brushing frequency did not change after the educational intervention. Education based on the HPM may be effective in promoting the oral health behavior of pregnant women. | PMC10422136 | |
Conclusion | tooth | According to the findings of the present study, the perceived benefits and positive feelings toward the behavior were improved, leading to a reduction in the perceived barriers and the negative feelings towards the behavior, ultimately an increase in the duration of tooth brushing. Although it seems that more methodical and long-term planning is needed to increase the frequency of brushing (2 times a day). Eventually, more studies are suggested regarding the effect of educational programs with a theoretical framework on preventive oral health behaviors during pregnancy. | PMC10422136 | |
Acknowledgements | We thank Hamadan University of Medical Sciences for their support. | PMC10422136 | ||
Authors’ Contribution | PMC10422136 | |||
Competing Interests | The authors declare no conflict of interests, financial or otherwise. | PMC10422136 |
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