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1. Introduction | intestinal microbiome | Human gut health is closely related to sleep. We aimed to evaluate the efficacy of yeast mannan (YM) in improving bowel habits and sleep quality, along with metabolomics in fecal samples. A total of 40 healthy adults (age range, 22–64 years) with discomfort in defecation were enrolled and randomly allocated to receive either YM (The human intestinal microbiome is a highly complicated ecosystem, in which several hundred microbial species consume, produce, and exchange hundreds of metabolites [An increasing number of people suffer from sleep problems owing to their nocturnal lifestyle and shorter sleep duration [ | PMC10780920 | |
2. Materials and Methods | PMC10780920 | |||
2.1. Study Design | MAY, SECONDARY | This was a double-blind, randomized, placebo-controlled, parallel study. Participants were recruited at the Department of Medical Management and Informatics, Hokkaido Information University (Hokkaido, Japan) and randomly allocated 1:1 to each group. The allocation was conducted by a third-party organization using block randomization. The assignment was blinded by participants, researchers, evaluators, and physicians until the investigation was completed. During this study, physical examination, blood sampling, and medical interviews were performed three times: the pretrial test, 0- and 4-week visits. Dietary surveys were conducted at 0- and 4-week visits. Before both 0- and 4-week visits, fecal samples and EEG data were collected. The participants were directed to take five YM/placebo tablets once a day during the intervention. The daily logs included information on bowel movements, tablet intake, menstrual status, physical status, and the use of other medications. The study was conducted from May 2021 to November 2021. The primary outcomes were defined as bowel habits assessed by the daily defecation log, and the secondary outcomes were defined as sleep quality and fecal properties assessed by quantitative PCR and metabolomics based on capillary electrophoresis time-of-flight mass spectrometry (CE-TOFMS). | PMC10780920 | |
2.2. Participants | The study participants included healthy Japanese adults between 20 and 64 years of age with discomfort in defecation. Sample size was calculated with G*Power 3.1 [ | PMC10780920 | ||
2.3. Tablets | YM was prepared from yeast cell walls by Asahi Group Foods, Ltd. (Tokyo, Japan), as previously reported [ | PMC10780920 | ||
2.4. Bowel Habits and Analyses of Fecal Samples | All participants were directed to record daily defecation frequency, stool volume, and stool form. Stool volume was compared with a ball-shaped model 40 mm in diameter. The stool form was evaluated according to the Bristol Stool Scale (BSS) [Fecal samples were collected per participant at the start and end of the intervention. The samples were frozen in the freezers after collection and brought to the study site during the visits. These samples were analyzed for metabolite composition and microbiota composition. Analyses using CE-TOFMS were performed using the Agilent CE-TOFMS system (Agilent Technologies, Waldbronn, Germany) with procedures developed by Soga et al. [DNA isolation from fecal samples was performed by beads beating previously described [ | PMC10780920 | ||
2.5. Analyses of Sleep Quality | Sleep EEG was measured by a patch-type EEG device (HARU; PGV Inc., Tokyo, Japan). The reliability of this device has already been confirmed by comparison with the International 10–20 system [ | PMC10780920 | ||
2.6. Diet Survey and Safety Evaluation | TG | ADVERSE EVENTS, EVENTS, BLOOD | The food frequency questionnaire (FFQ) was used to assess dietary and nutrient intake. Safety was assessed using diary records, medical interviews, general blood tests, and physical examinations. All adverse events (AEs) and side effects were monitored in participants who took the test tablets at least once, and the incidence of these events was calculated. Blood pressure, pulse rate, and body weight were measured at every visit, whereas body height was measured only at the first visit. Blood samples for general biochemical examinations were obtained in a fasting state at each visit and were measured for the following items at Sapporo Clinical Laboratory Inc. (Sapporo, Japan): white blood cells (WBC), red blood cells (RBC), hemoglobin (Hb), platelet count (Plt), and hematocrit (Ht) for complete blood count test; total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride (TG) for lipid panel tests; fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) for blood glucose profile test; creatinine (CRE), uric acid (UA), and blood urea nitrogen (BUN) for renal function assessment; and gamma-glutamyl transpeptidase (γ-GTP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline phosphatase (ALP) for liver function assessment. A medical interview was conducted by a clinical physician at every visit. | PMC10780920 |
2.7. Ethics Committee | COVID-19 infection | MAY, COVID-19 INFECTION | The study protocol was approved by the Bioethics Committee of Hokkaido Information University (Hokkaido, Japan) per the principles of the Declaration of Helsinki (approval date: 28 April 2021; approval number: 2021-13). The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trial Registry as UMIN000044175 (date of registration: 11 May 2021). The study involved one revision of the clinical trial protocol. The contents were (1) the postponement of the study due to the declaration of a state of emergency following the spread of the COVID-19 infection and (2) changes to the case-fixing conditions following the postponement of the study. The changes were approved by the Bioethics Committee of Hokkaido University through an expedited review (approval date: 11 June 2021; approval number: 2021–2024). Written informed consent was obtained from all participants before enrollment. | PMC10780920 |
2.8. Statistical Analysis | Statistical analyses were performed using SPSS version 25 software (IBM Japan Ltd., Tokyo, Japan). For intergroup comparison, parametric tests were performed using the Student’s | PMC10780920 | ||
3. Results | PMC10780920 | |||
3.1. Demographics | Eighty-two participants were initially recruited, out of which forty-two were excluded and randomly assigned to the YM or placebo treatment. | PMC10780920 | ||
3.2. Bowel Movements, Stool Volume, and BSS | Changes in defecation frequency (times/day) during the treatment period were significantly greater in the YM group than in the placebo group ( | PMC10780920 | ||
3.3. Sleep | The sleep quality was evaluated using an EEG device, and the results were summarized in | PMC10780920 | ||
3.4. Fecal Properties | Changes in both copy number (copies/g feces) and relative abundance (%) of | PMC10780920 | ||
3.5. Relationship between Fecal Metabolites and Sleep | REGRESSION | To explore the relationship between sleep quality and gut environment, forward stepwise linear regression analysis was applied using 20 differential metabolites as independent valuables. The respective sleep parameters, TIB or N3 latency time, were used as dependent variables. As | PMC10780920 | |
3.6. Safety | Changes in blood pressure, complete body composition, blood cell content, lipid parameters, renal function, and liver function were assessed. The change in Ht (%) was significantly lower in the YM group than in the placebo group (No side effects or severe or moderate AEs were observed during the intervention. Seventeen mild AEs were recorded during the study period. In the YM group, eleven AEs were recorded, including elevated ALT ( | PMC10780920 | ||
4. Discussion | Chronic constipation, insomnia, Constipation | REGRESSION, MINOR | This study aimed to assess whether supplementation with YM would confer health benefits to healthy adults experiencing discomfort in defecation. Recently, we reported that the regular intake of YM for eight weeks improved the bowel habits of healthy women aged 30–49 years [Constipation can occur in anyone as a minor discomfort that may result from altered gut motility. Chronic constipation is estimated to affect about 10–15% of the population and significantly impacts the quality of life [More importantly, we found that supplementation with YM as a prebiotic could alter sleep architecture and contribute to better sleep quality. Recent studies have focused on the interaction between gut microbiota and sleep disturbances, indicating that a healthy gut environment, including microbiota and metabolite composition, is increasingly important for host health [We hypothesized that changes in the levels of certain metabolites in the colon following changes in the gut microbiota composition due to YM intake would be responsible for the effects of YM on sleep quality. We also evaluated the impact of YM intake on fecal metabolites using a CE-TOFMS-based metabolomics approach. As a result, 20 differential metabolites between the YM and placebo groups were screened. This study represents the first report on the alteration of fecal metabolites following YM administration. To explore the metabolites associated with changes in objective sleep parameters—TIB or N3 latency, which were significantly altered by YM ingestion—stepwise linear regression was performed using these twenty differential metabolites as independent variables. Relationships between the changes in fecal metabolites and each sleep variable were found. The extension of TIB could be explained in 53.0% by elevated propionate levels in feces. However, the shortened N3 latency could be explained at 59.3% by increased GABA and dTMP levels. Even GABA concentration alone could also explain 33.3% of the change in N3 latency. Based on the above, the effect of YM on sleep might be explained via at least two routes: gut-derived propionate and GABA.First, regarding the association between sleep and fecal propionate level, a prior study in preschool-aged children found that the fecal propionate concentration was lower in children with long wake times after sleep onset, indicative of difficulty maintaining sleep [In addition, we consider the possible effects of gut-derived GABA on sleep quality. Our results found that fecal GABA levels were increased by YM administration. GABA is a key inhibitory neurotransmitter closely related to sleep, and GABA receptors are pivotal targets for pharmaceuticals, such as benzodiazepine, to alleviate insomnia [One limitation of this research is that the EEG data collection was partly incomplete. Incomplete EEG data due to inappropriate use of equipment reduced the sample size of the EEG data set, although this reduction is in line with the missing data observed in previous EEG studies. Although bowel habits may be affected by diet, we did not impose strict dietary restrictions on participants or provide uniform diets. | PMC10780920 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10780920 | ||
Author Contributions | N.H. | Conceptualization, J.N., N.H. and T.H.; investigation, A.H., H.K.-K., M.S., M.Y. and R.T.; resources, J.N., N.H. and T.H.; methodology and formal analysis, H.K-K.; writing—original draft preparation, R.T.; writing—review and editing, T.H. and M.Y.; supervision, N.H.; project administration, J.N. All authors have read and agreed to the published version of the manuscript. | PMC10780920 | |
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Bioethics Committee of Hokkaido Information University (approval date: 28 April 2021; approval number: 2021-13, Ebetsu, Hokkaido, Japan). This study was registered at | PMC10780920 | ||
Informed Consent Statement | Informed consent was obtained from all participants involved in the study. | PMC10780920 | ||
Conflicts of Interest | R.T., M.Y., M.S. and T.H. are employees of Asahi Quality and Innovations, Ltd., related to Asahi Group Holdings, Ltd. The other authors declare that the research was conducted without any financial relationships that could be considered as potential conflicts of interest. The funder, SIP, had no role in the design of the study, in the collection, analysis, or interpretation of data, in the writing of the manuscript, or in the decision to publish the results. | PMC10780920 | ||
References | REGRESSION | CONSORT flow diagram.Effects of YM on bowel habits. (Effects of YM intake on the fecal metabolome. (Participant’s background characteristics (per protocol set).Numerical data are presented as mean ± standard deviation (SD). Categorical data are presented as numbers (percentages).Sleep measurements.Values are presented as mean ± SE. The Quantitative PCR.Values are presented as mean ± SE. Forward stepwise regression analysis for TIB and N3 latency.Data are shown at TIB and N3 latency and include the independent valuables for each model. Abbreviations: TIB, total time in bed; N3, non-REM sleep stage 3. | PMC10780920 | |
Background | NMD, peripheral neuropathy or neuromuscular disease, evertor weakness, Neuromuscular disease, peripheral neuropathy, AFO | PERIPHERAL NEUROPATHY, NEUROMUSCULAR DISEASE | Neuromuscular disease and peripheral neuropathy may cause drop foot with or without evertor weakness. We developed a helical-shaped, non-articulated ankle–foot orthosis (AFO) to provide medial–lateral stability while allowing mobility, to improve gait capacity. Our aim was to evaluate the effect of the helical AFO (hAFO) on functional gait capacity (6-min walk test) in people with peripheral neuropathy or neuromuscular disease (NMD) causing unilateral drop foot and compare with a posterior leaf spring AFO (plsAFO). Secondary aims were to compare functional mobility, 3D kinematic and kinetic gait variables and satisfaction between the AFOs. | PMC10176820 |
Methods | peripheral neuropathy | PERIPHERAL NEUROPATHY | Single centre, randomised crossover trial from January to July 2017 in 20 individuals (14 with peripheral neuropathy and 6 with NMD, 12 females, mean age 55.6 years, SD 15.3); 10 wore the hAFO for the first week and 10 wore the plsAFO before switching for the second week. The 6-min walk test (6MWT), Timed Up and Go (TUG) test and 3D gait analysis were evaluated with the hAFO, the plsAFO and shoes only (noAFO) at inclusion and 1 week after wearing each orthosis. Satisfaction was evaluated with the Quebec user evaluation of satisfaction with assistive technology (QUEST). | PMC10176820 |
Results | orthosis | Median [interquartile range] 6MWT distance was greater with the hAFO (444 m [79]) than the plsAFO (389 m [135], P < 0.001, Hedge’s g = 0.6) and noAFO (337 m [91], P < 0.001, g = 0.88). TUG time was shorter with the hAFO (8.1 s [2.8]) than the plsAFO (9.5 s [2.6], P < 0.001, g = − 0.5) and noAFO (10.0 s [2.6]), P < 0.001, g = − 0.6). The plsAFO limited plantarflexion during the loading response (plsAFO − 7.5 deg [6.0] vs. noAFO -13.0 deg [10.0], P = 0.0007, g = − 1.0) but the hAFO did not (− 11.0 deg [5.1] vs. noAFO, P = 0.05, g = − 0.5). Quasi-stiffness was lower for the hAFO than plsAFO (P = 0.009, g = − 0.7). The dimensionless eversion moment was higher (though not significantly) with the hAFO than noAFO. Neither orthosis reduced ankle power (P = 0.34). Median total QUEST score was higher for the hAFO (4.7 [0.7]) than the plsAFO (3.6 [0.8]) (P < 0.001, g = 1.9). | PMC10176820 | |
Keywords | PMC10176820 | |||
Introduction | NMD, loss of evertor strength, stroke, orthosis, AFOs, Disability, peripheral neuropathy, AFO | DISEASES, STROKE, NEUROMUSCULAR DISEASE, SECONDARY, PERIPHERAL NEUROPATHY | Diseases that affect the strength of the dorsiflexor muscles, such as stroke, peripheral neuropathy and neuromuscular disease (NMD), can result in foot drop. Foot drop restricts gait capacity and induces compensatory strategies, such as increased hip and knee flexion, to clear the foot and avoid tripping [Ankle–foot orthoses (AFOs) are commonly prescribed, conservative methods to reduce foot drop and improve gait capacity [Many types of AFOs have been designed and different materials have been used [According to Alam et al. (2014), the ideal AFO must meet the following design specifications: be lightweight, compact, efficient, and untethered, prevent drop foot during swing while allowing normal ankle motion during other phases, and assist push off if necessary [Few commercialised orthoses currently meet all these criteria: carbon orthoses are lightweight and compact and may provide some push off assistance [One of the authors of the present study (BC) designed and developed a new type of carbon fibre orthosis with a helical shape that would: (1) prevent foot drop in swing, (2) allow normal ankle range of motion, (3) not reduce propulsion and (4) provide medial–lateral stability of the ankle. It was also intended to be lightweight, and aesthetically acceptable. Such an orthosis could improve gait capacity.The purpose of this study was first to determine if the orthosis improved gait capacity, which is the main aim of the wearer (activities level of the International Classification of Functioning, Disability and Health [The primary aim of this study was to evaluate the effect of this helical AFO (hAFO) on functional gait capacity (distance) in comparison with the effects of a posterior leaf spring AFO (plsAFO) or no AFO in patients with peripheral neuropathy or NMD causing drop foot with or without a concomitant loss of evertor strength. The secondary aims were to evaluate and compare functional mobility, 3D kinematic and kinetic gait variables and satisfaction between the two types of AFO. | PMC10176820 |
Methods | PMC10176820 | |||
Study design | orthosis, AFO | We conducted a single centre, randomized crossover trial from January to July 2017. Two types of orthoses were evaluated: a posterior leaf spring AFO (plsAFO) and the specifically designed, helical AFO (hAFO). Participants were randomised to wear one of the orthoses in their usual environment for 1 week and the other orthosis for the following week. Randomisation of the order of the orthoses (plsAFO first or hAFO first) was performed using a computer-generated list created by the study clinical research organisation (4-block randomisation). Two doctors enrolled consecutive participants and performed the group allocation. The evaluations were performed in the same order. Neither the participants nor the evaluators were blinded to the condition.The study schedule is shown in Fig. Flow chart of study schedule | PMC10176820 | |
Participants | Adult Neuromuscular Disease, spasticity, fatigue, peripheral neuropathy, AFO | AIDS, PERIPHERAL NEUROPATHY | According to the sample size calculation performed with G*Power 3.1 software (data from Nolan et al. 2009 [Inclusion criteria were: adults (over 18 years old) with unilateral drop foot caused by peripheral neuropathy or NMD who usually wore an AFO, Medical Research Council (MRC) score of the dorsiflexor or evertor muscles < 3 or score of 3 on testing but the person complained of fatigue that resulted in foot drop during gait, MRC score of at least 4 in the hip and knee flexors and extensors and plantarflexors of the contralateral limb, able to walk safely without an AFO for at least 6 min (with or without gait aids), and able to understand simple instructions. Individuals were excluded if they had any lower limb spasticity, required bilateral assistive devices for gait, had undergone lower limb surgery in the 6 previous months that could affect gait, or if they were unable to provide written informed consent. Eligible individuals were consecutively screened during routine consultations in the Adult Neuromuscular Disease Department of Toulouse University Hospital. Those who agreed to participate (20 out of 25 individuals) attended the inclusion visit and signed the consent form.
| PMC10176820 |
Posterior leaf spring AFO | orthosis | The plsAFO was made from a single piece of thermoformable polypropylene that encompassed the dorsal part of the leg and the sole of the foot (Fig. The same trim line was used for all plsAFOs. The proximal edge was 4 cm below the popliteal fossa. The anterior edge (medial and lateral) followed a line that passed from proximal to distal, just in front of the centre of the calf in the sagittal plane to the posterior border of the malleolus. The orthosis supported the medial arch of the foot to the head of the first metatarsal before flattening.This orthosis prevented plantarflexion during swing phase and allowed passive ankle dorsiflexion during stance phase. It is commonly used in France [ | PMC10176820 | |
Helical AFO | orthosis, EVA foam, AFO | The helical ankle–foot orthosis (hAFO) from InnovPulse (Vernaison, France) [All the hAFOs were custom designed and fabricated from multiple layers of carbon. Layers of dry carbon fibre were superimposed between 2 closed end PVA bags over the plaster positive and epoxy resin was injected to bind the layers. The pieces were positioned over the tracing of the AFO on the plaster positive. The resin was then polymerised. The hAFO was cut along the trace using a diamond Dremel wheel. The edges were rounded on a rotary power tool before hand-finishing with fine-grain sandpaper. After cleaning with alcohol, EVA foam (1.5 mm) was fitted on the distal part of the hAFO, up to the lower edge of the lateral malleolus. The strap was then added on the proximal part of the orthosis.The same trim line was used for all hAFOs: a helical shaped band passed laterally under the metatarsal heads, medially over the dorsum of the foot, under the heel, anterior to the lateral malleolus, behind the calf and fixed with the strap just distal to the knee (Fig. | PMC10176820 | |
Evaluations | All participants attended 3 evaluation visits (Fig. Visit 1: the physician verified the inclusion criteria and collected demographic data (age, sex and body mass index). Strength of the dorsiflexor, evertor and plantar flexor muscles was evaluated with the MRC to characterise the participants [Visit 2: one week after wearing the first orthosis, the 6MWT and TUG test were performed with the participant wearing the first orthosis, and the Quebec user evaluation of satisfaction with assistive technology (QUEST) was rated. A 10-min rest was allowed between each test. Participants all wore the same type of shoes (ordinary, low trainers, Fig. Visit 3: 1 week after wearing the second orthosis, the same tests were performed in the same conditions as for Visit 2 with the participant wearing the second orthosis. In addition, 3D gait analysis was performed in all 3 conditions. | PMC10176820 | ||
Outcome measures | PMC10176820 | |||
Primary outcome | PMC10176820 | |||
6-min walk test (6MWT) | The 6MWT is a functional measure of gait capacity that evaluates the distance walked over a period of 6 min. The test was performed in a 30-m straight corridor. Participants were instructed to walk as far as possible within the 6 min and standardised instructions were used [ | PMC10176820 | ||
Secondary outcomes | PMC10176820 | |||
Timed up-and-go test (TUG) | The timed up and go (TUG) test measures mobility, including static and dynamic balance [ | PMC10176820 | ||
The Quebec user evaluation of satisfaction with assistive technology (QUEST) | AFO | The QUEST 2.0 (validated in French version) was used to evaluate participants’ level of satisfaction with each AFO [ | PMC10176820 | |
Harms | AFO | SKIN LESIONS | Harms were collected at each visit: participants were asked if they had experienced any skin lesions or falls or any other problems they believed were related to the AFO. | PMC10176820 |
Adherence | AFOs | Participants reported wearing both AFOs as requested, i.e., during activities of daily living. | PMC10176820 | |
3D gait analysis | Kinematic and kinetic gait variables were recorded on a 10 m runway with 8 cameras (Vicon Oxford Metrics, recording frequency 100 Hz) and 2 force platforms (AMTI OR6-7, Advanced Mechanical Technology Inc., Watertown, MA, recording frequency 1000). A set of 16 markers was fixed to bony landmarks according to the Helen Hays model [Gait speed was fixed at the individual’s speed measured during the 6MWT in the noAFO condition (mean 0.95 m/s, SD 0.25) so that changes in gait speed between conditions would not confound kinematic and kinetic results. A running light-emitting diode by the side of the walkway set to the participant’s gait speed was used to guide them.Trials in which participants placed the evaluated foot correctly on the force platforms were considered and were included in the analysis if at least 4 gait cycles with complete kinematic and kinetic data were available for the participant. Standardised kinematic [The eversion moment of the ankle joint was considered relevant to indicate ankle stability. | PMC10176820 | ||
Statistical analyses | The data did not follow a normal distribution (Shapiro–Wilk test and visual inspection). The Friedman test was used to compare the effects of the conditions (hAFO, plsAFO and noAFO) on the 6MWT, TUG test and the 13 variables from the 3D gait analysis. When significant differences were found, the Wilcoxon test was used post-hoc to determine which conditions differed. The Wilcoxon test was also used to compare the hAFO and plsAFO conditions on the two QUEST subscales (device and services) and the total QUEST score. To control the false discovery rate, a Bonferroni procedure was performed to adjust the alpha risk threshold (P-value) at 0.0031 (0.05/16) for the 13 Friedman tests and 3 Wilcoxon tests (n = 3) and at 0.017 for the 3 post-hoc Wilcoxon tests (n = 3) for each significant Friedman test. Effect sizes were also calculated using Hedges’ g adapted for dependent data [ | PMC10176820 | ||
TUG | All 20 participants completed the TUG test. TUG performance time was significantly affected by the condition. The post-hoc analysis showed that this time was significantly shorter (i.e., better) with the hAFO than the plsAFO (Table Mean TUG performance time is 10.4 s (SD 2.3) in healthy individuals aged 60–64 years [ | PMC10176820 | ||
3D gait analysis | orthosis, AFOs | Complete kinematic and kinetic data with at least 4 gait cycles were available for 15 participants out of the 20. Technical issues occurred for 3 participants (e.g., they placed both feet on the same force platform preventing kinetic analysis). Only one cycle was available for 2 other participants which prevented appropriate averaging.Three kinematic and kinetic variables were significantly affected by the condition and are presented below.First, peak plantarflexion during early stance was significantly affected by the condition. This peak was significantly lower with the plsAFO than the hAFO. It was also lower with the plsAFO than noAFO, with no difference between the hAFO and noAFO (Table Median (IQR) curves for dorsiflexion/plantarflexion angle, eversion moment and power throughout the gait cycle for each condition (noAFO: shoes only, plsAFO: posterior ankle foot orthosis; hAFO: helical ankle foot orthosis)Second, peak plantarflexion during swing phase was significantly affected by the condition. This peak did not differ between the plsAFO and hAFO. However, it was lower with both AFOs than noAFO (Table Third, dimensionless quasi-stiffness in the first linear part of the plantar/dorsiflexion moment–angle curve was significantly affected by the condition. This stiffness was significantly lower for hAFO than plsAFO. It was also significantly lower for noAFO than for plsAFO and hAFO (Table Results for each participant for non-dimensional quasi stiffness for the three conditions (noAFO: shoes only, plsAFO: posterior ankle foot orthosis; hAFO: helical ankle foot orthosis)No significant between-condition differences were found for any other kinematic and kinetic variables. However, the P-value for the effect of the condition on the dimensionless peak eversion moment in stance phase (which we considered to be representative of medio-lateral ankle stability) was quite low (P = 0.015) (Table | PMC10176820 | |
The Quebec user evaluation of satisfaction with assistive technology (QUEST) | All participants completed the QUEST. Median QUEST scores for the device subscale were 3.2 (IQR 0.8) for the plsAFO and 4.6 (0.9) for the hAFO, corresponding to “more or less satisfied” and “quite satisfied-very satisfied” respectively. This score was significantly higher for the hAFO condition. Median scores for the services subscale were 4.6 (1.3) for the plsAFO and 5 (0.3) for the hAFO corresponding to “quite-very satisfied and “very satisfied” with no significant between group differences. Median total QUEST score was significantly higher for the hAFO: 4.7 (0.7) versus 3.6 (0.8). The results for each item are shown in Fig. | PMC10176820 | ||
Harms | AFO | No harms were reported by any participants at any assessment for either type of AFO. | PMC10176820 | |
Discussion | spasticity, stroke, orthosis, AFOs, peripheral neuropathy | STROKE, PERIPHERAL NEUROPATHY, CEREBRAL PALSY | To our knowledge, this is the first study of a helical-shaped ankle–foot orthosis (hAFO) designed to reduce foot drop and improve medial–lateral stability of the ankle in individuals with peripheral neuropathy or NMD, with no spasticity. The results showed that the helical orthosis increased functional gait distance (6MWT) and functional mobility (TUG test performance time) statistically significantly and considerably more than the posterior leaf spring orthosis. Furthermore, the kinematic and kinetic analyses showed that the hAFO allowed more physiological ankle mobility whilst providing some lateral stability, which was not the case for the plsAFO. Participants’ rating of satisfaction was significantly higher with the hAFO than the plsAFO.The majority of studies performed to evaluate AFOs have been conducted in individuals with stroke or cerebral palsy, and a much smaller number have been conducted in people with peripheral neurological or neuromuscular conditions [ | PMC10176820 |
Impact of the helical orthosis on functional gait distance and mobility | AFO, stroke, ’ | STROKE | 6MWT distance was significantly greater with the hAFO than the plsAFO, with a moderate effect size. Furthermore, almost all participants could be considered as ‘responders’ to the hAFO, which was not the case for the plsAFO, and the median change from noAFO with the hAFO largely surpassed the MCID, whereas change with the plsAFO did not reach the MCID.Comparison with the literature found smaller improvements in 6MWT distance with different types of AFO, although few studies included samples similar to our sample. In people with stroke, the use of a posterior AFO improved 6MWT distance by approximately 30 m compared with no AFO [TUG test performance time was significantly shorter (i.e., better) with the hAFO than the plsAFO. The TUG test measures several aspects of gait including sit-stand capacity, speed and balance. The better TUG performance with the hAFO likely results from a combination of a higher gait speed because of the reduction in foot drop, and better stability, as indicated by the increased eversion moment for some participants, which may have facilitated balance and increased turning speed. Studies in subacute or chronic stroke found greater improvements in TUG performance time than we did in the present study (up to a mean 6 s difference between various types of AFO and noAFO conditions) [ | PMC10176820 |
Effect of the helical orthosis on biomechanical gait variables | peripheral neuropathy, weakness of the evertor muscles, AFOs, AFO | PERIPHERAL NEUROPATHY | This is one of the first studies to evaluate the impact of AFOs on biomechanical gait variables in patients with peripheral neuropathy or NMD. The purpose of this analysis was to explain the results of the functional gait tests, however fewer significant effects of the condition were found on kinematic and kinetic variables than expected. This could result from several factors. First, we controlled the gait velocity: participants were constrained to walk at the same speed as the noAFO condition in both AFO conditions. Gait speed was therefore sub-maximal in the AFO conditions since participants were able to walk faster with the AFOs, as demonstrated by the 6MWT results. We chose this design to differentiate the specific effects of the AFO on ankle biomechanics from the more general effect, which is typically an increase in gait velocity. Second, as can be seen in Table The primary aim of an AFO is to prevent foot drop during swing phase. Median peak plantarflexion during swing was above − 5 deg with both the plsAFO and hAFO, showing that the support provided under the forefoot reduced plantarflexion. Our next aim in the design of the hAFO was that it should not interfere with ankle mobility. The results showed that this was achieved with the hAFO whereas the plsAFO limited plantarflexion during the loading response. However, although the median difference in this plantarflexion angle was significant between the hAFO and the plsAFO, it was only of 1.1° and therefore could result from measurement error. Furthermore, although quasi-stiffness during stance was higher with the hAFO than in the noAFO condition, the value was lower than with the plsAFO. Quasi-stiffness provides an indication of overall joint stiffness, including muscles and ligaments combined with the stiffness of the AFO [The hAFO was designed with a heel cup to provide ankle stability in the frontal plane since people with peripheral neuropathy or NMD often have weakness of the evertor muscles. The inversion/eversion moment has rarely been studied in the literature in comparison with the plantar/dorsiflexion moment [Although the hAFO was also designed to increase propulsion thanks to its spring like behaviour (carbon material and helical shape), we did not demonstrate this effect. However, this could not be fully analysed due to the design of the study which involved a controlled gait speed. However, in contrast with some other orthoses [ | PMC10176820 |
Satisfaction | AFOs, neuromuscular disease | NEUROMUSCULAR DISEASE | Few studies have assessed patient satisfaction with AFOs using a validated questionnaire. We used the QUEST for this purpose since it has good reliability and validity [A study of carbon fibre Toe-OFF and BlueRocker AFOs found that 109 of 123 patients with neuromuscular disease preferred these orthoses to their previous AFOs because they found them lighter, cooler, they provided push-off and allowed them to wear a normal sized shoe [ | PMC10176820 |
Limitations | heterogenous, orthosis, AFOs, AFO | AIDS | The inclusion of a heterogenous sample of participants with peripheral neurological and neuromuscular disorders could be considered as a limitation. However, all participants were able to walk for at least 6 min with noAFO (but gait aids such as sticks were allowed), which is typical of AFO users with foot drop that is not of central neurological origin. The helical orthosis evaluated is thus suitable for this population.No recommendations exist regarding the time required for individuals to accommodate to a new AFO and adapt their gait. Therefore, we do not know if 7 days was sufficient for accommodation to have fully occurred.We were unable to fully analyse the effect of the AFOs on propulsion owing to the sub-maximal gait speed imposed on participants. Further studies should therefore evaluate the biomechanical effects of the hAFO at the participants’ own, spontaneous gait speed.The fact all the orthoses were made by the same orthotist ensured homogeneity in the moulding and manufacturing of the orthoses; however, future studies should evaluate the repeatability of hAFOs made by different orthotists. | PMC10176820 |
Conclusions | NMD, peripheral neuropathy, peripheral neuropathy or neuromuscular disease | PERIPHERAL NEUROPATHY | This study showed promising improvements in some outcome measures for a small group of individuals with peripheral neuropathy or NMD who have drop foot. The new hAFO improves gait capacity more, may have better biomechanical function, is more aesthetic, is lighter in weight and induces higher levels of satisfaction than the plsAFO. These results suggest that the hAFO can be prescribed for individuals with peripheral neuropathy or neuromuscular disease who have drop foot and/or ankle instability that reduces their gait capacity. | PMC10176820 |
Acknowledgements | Lagarde T | We warmly thank the study participants for their participation in this study and Cruz MC, Lagarde T (PhD), Serres B and Verniers R for technical assistance and assistance with data collection. We are very grateful to Orthopedie Cornier Thierry Occitane 31 for their support. We also thank Johanna Robertson for writing assistance, and Prof. T. Levade for constructive criticism. | PMC10176820 | |
Author contributions | DG, BC, PC, RG and MCAB conceived and designed the study, RD developed the software, PC, BA and MCAB recruited participants, MS performed the data acquisition, DG, RD and MS analysed the data, DG, RD, and BA interpreted the data, DG, RD and BC drafted the article, PC and BA revised the article. All authors read and approved the final manuscript.
| PMC10176820 | ||
Funding | Funding was provided by InnovPulse. | PMC10176820 | ||
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10176820 | ||
Declarations | PMC10176820 | |||
Ethics approval and consent to participate | Ethical approval was granted by the institutional review board at our facility (CPP RC31/16/8711UA 0961/2016; 2016-AO1037-44) and all participants gave informed consent for their participation. | PMC10176820 | ||
Consent for publication | Not applicable. | PMC10176820 | ||
Competing interests | orthosis | One of the authors, Benoit Caussé is the inventor of the orthosis [ | PMC10176820 | |
References | PMC10176820 | |||
Background | DM2 | TYPE 2 DIABETES MELLITUS | Type 2 diabetes mellitus (DM2) is a leading cause of morbidity and mortality worldwide and is considered a global epidemic. Despite the growing evidence on the effectiveness of mobile health interventions in the management of DM2, the evidence on the effect of mobile health interventions in prevention of DM2 is sparse. Therefore, we have developed an app aiming to promote initiation of behavioral change and adherence to healthy behavior. Before commencing a small-scale randomized controlled trial to assess the feasibility of using an app for initiation and adherence of healthy behavior in people at risk of DM2, testing the usability of the app in the target population is warranted. | PMC10687681 |
Objective | DM2 | The aim of this study was to assess the usability of an app among people at risk of DM2. | PMC10687681 | |
Methods | A qualitative study with the use of a think aloud (TA) procedure was conducted from April to November 2022. The TA procedure consisted of 10 problem-solving tasks and a semistructured interview which was carried out after the tasks. These interviews served to gain more in-depth knowledge of the users experience of the problem-solving tasks. The TA-sessions and the postactivity interviews were recorded and transcribed verbatim, and the data were coded and analyzed following the principles of thematic analysis. | PMC10687681 | ||
Results | DM2 | In total, 7 people at risk of DM2 with a median age of 66 (range 41-75) years participated in this study. The analysis resulted in the following themes: (1) user interface design; and (2) suggestions for improvements of the functionality of the app. | PMC10687681 | |
Conclusions | MINOR | Overall, the participants were satisfied with the usability of the app. Through the TA-sessions, real time perspective on the appeal, relevance, and utility of the app were gained. Only minor changes to the functionality of the prototype app were reported as necessary to improve the usability of the app. Points of guidance from the participants in this study have been adopted and incorporated into the final design of the app now being assessed for feasibility in a small-scale randomized controlled trial. | PMC10687681 | |
Introduction | cardiac diseases, DM2 | TYPE 2 DIABETES MELLITUS, CARDIAC DISEASES | Type 2 diabetes mellitus (DM2) is a leading cause of morbidity and mortality worldwide and is considered a global epidemic [Initiation and adherence to behavioral change is a complex process. In a previous randomized controlled trial (RCT), we found that long-term follow-up using an app to promote adherence to healthy behavior postcardiac rehabilitation (post-CR) was effective with regard to exercise capacity, exercise performance, exercise habits, and in self-perceived goal achievement [To be able to successfully initiate and adhere to behavioral change by using an app, it is necessary to consider the participants´ motivation for behavioral change as well as the participants’ motivation for using an app as an intervention (or as guidance) in the behavioral change process. In a previous qualitative study on post-CR patient´s experiences of using an app, we found that being followed by a real person and providing individualized feedback, most likely is the most significant success factor in promoting adherence to healthy behavior with an app [Importantly, but not surprisingly, the relationship between health personnel and the patients with DM2 have been shown to influence clinical outcomes [Based on the described experiences and the current existing knowledge base, more knowledge on efficacy of mHealth interventions in prevention of DM2 is needed. Hence, we developed the People Living Under change (Plunde) app, aiming to promote initiation of behavioral change and adherence to healthy behavior. Before commencing a full scale RCT evaluating the effect of this app on risk reduction in people at risk of DM2, we plan to conduct a small scale RCT feasibility study to evaluate whether the full scale RCT can be conducted in the way it is planned or whether it needs to be modified. However, as our experiences with using apps primarily is in patients with cardiac diseases and the fact that experiences and perspectives of the end users need to be implemented in the development and evaluation of apps [ | PMC10687681 |
Methods | PMC10687681 | |||
Study Design, Setting, and Participants | A qualitative study with the use of a think aloud (TA) protocol [ | PMC10687681 | ||
Theoretical Framework | Using an app as an intervention, or as a part of an intervention, can be considered as a complex intervention defined as an intervention containing several interacting components [ | PMC10687681 | ||
App Development and Main Features and Functions in Plunde | Based on previous research [Using specific behavior change strategies and techniques in different stages of change may be useful in providing support, and thereby promoting adherence to healthy behavior [In addition to goal setting, a crucial function highlighted by patients in our previous research was individualized feedback provided by a real person [In addition to the mentioned functions, Plunde also includes a personal note function. This function is intended to support in self-monitoring which is found to be a motivational factor in changing behavior [User interface of Plunde. (A) Menu with an overview of the features. (B) My goals. (C) Tasks related to the goals. | PMC10687681 | ||
TA Procedure | The TA method enabled us to identify usability issues related to Plunde via observation and self-report [The problem-solving tasks was based on real-life scenarios addressing usability testing of all the main functions of Plunde. Based on experiences from previous research conducted by the research group [ | PMC10687681 | ||
Problem-solving tasks. | nonverbal behaviors, GS | Go to the main menu and find “my goals”Find the tasks related to your goalsSend a message to your supervisorDelete a messageCreate a noteDelete the noteFind the reminders that are linked to the tasksChange a reminder that is linked to one of the tasksFind information about healthy dietFind a video about physical activityThe TA-sessions were conducted in the period from April 2022 to November 2022. They took place at the localities of the different Healthy Life centers, at the University campus, or in the home or workplace of the participants. Participants were given a test phone being either an iOS or Android, depending on which operative system they had on their own smartphone. Each session started with a short introduction of Plunde and an explanation of the aim of the research project. Further, the procedure for testing the usability of Plunde was explained. The participants were instructed to TA (verbalization of thoughts) while performing the problem-solving activities and it was emphasized that the purpose of these tasks was not to measure their digital skills but to test the usability of Plunde.The TA-sessions were recorded. Further, field notes were taken during the problem-solving tasks to record any observed technical difficulties encountered, ease of use, and learning as well as nonverbal behaviors related to the task management. The observer or interviewer (GS) reminded the participants to continue thinking aloud when they stopped doing so. If a participant was not able to solve a task after several attempts, the observer or interviewer provided a cue, in order to see whether and in what way, the task was solvable. After completing the TA-session, the participants received a cinema gift card valued 400 Norwegian kroner (US $40). | PMC10687681 | |
Ethical Considerations | Ethical approval was obtained from the Norwegian Centre of Research Data (ID: 887029). All included participants provided written informed consent. | PMC10687681 | ||
Results | PMC10687681 | |||
Participants and Their Characteristics | DM2 | In total, 7 people at risk of DM2 with a median age of 66 (range 41-75) years participated in this study, 3 were women and 4 were men. Regarding educational level, 1 had finished primary education, 2 had finished high school, 3 had 1-3 years of college or university, and 1 had more than 3 years of higher education. In terms of smartphone and app use, 6 participants reported that they used apps every day and 1 participant reported several times per week. The participants responded to the statement “I have good skills and competence in the use of smartphones and applications” as follows; “highly agree” (n=2), “agree” (n=4), and “I both agree and disagree” (n=1). | PMC10687681 | |
Usability | PMC10687681 | |||
General Findings | On average, the TA-sessions lasted for a range of 44-67 (SD 8.3) minutes. The usability based on tasks completed in the TA observation are summarized in | PMC10687681 | ||
User Interface Design | confusion | Feedback concerning the design of Plunde was mostly positive. It was pointed out by three of the participants that the layout was recognizable and similar to other apps, which made it easier to navigate based on experience. Most of the participants experienced that the menu was comprehensible. The participants had no problem finding the menu in Plunde. They liked that the menu was not overloaded with too much information. Additionally, most of the participants pointed that they liked the size of the font which made readability good. Generally, participants managed moving back and forth between the menu and different features, with few exceptions as mentioned below.All participants located the personal goal feature and the tasks related to the personal goal. A novel feature of Plunde is the message feature that enables communication between participants with a supervisor (health care professional). Further, 2 participants found it challenging sending a message to the supervisor. However, this was solved quickly with cues from the interviewer. In order to delete a message in Plunde, the participant is required to swipe left. All except 1 participant had problems deleting a message once it was written. The participants kept searching for a button icon for deleting instead of swiping leftwards. When a cue was given, this was understood, but all the participants commented that this was illogical.When continuing the navigation to the note feature, only one of the participants had some difficulties writing up a note. This participant could not find the keyboard at first. When given a cue about this, the participant continued only to lose the keyboard again. Further, 1 participant experienced some confusion regarding writing the headline of the note versus the content of the note as well as saving the note. Furthermore, deleting the note was perceived as easier than deleting a received message (problem-solving task number 4, When moving to the reminder part of the navigational task (problem-solving task numbers 7 and 8, None of the participants had trouble with the 2 tasks of finding information and videos related to lifestyle advice. Likewise, all but one found the link to a governmental health information video on physical activity. Further, 3 participants had trouble navigating back to Plunde from the video link. When cued by the interviewer, they managed this promptly. | PMC10687681 | |
Suggestions for Improvements to the Functionality of the App | All the participants pointed out some flaws in the design of Plunde that could be improved. The functions related to deleting and saving, both notes, tasks, and reminders, in Plunde were the most challenging. Hence most suggestions for improvement concerned these functions.The delete function for messages was suggested to be changed from swiping to a “button/icon” to be tapped or double-tapped. A trashcan icon was suggested as an alternative as it was perceived as more in line with other apps familiar to the participants. Further, it was suggested that the save button for the personal notes feature should have been placed at the top of the page. What is more, to change the timing of reminders, a keyboard was suggested as a more user-friendly input method than the scroll function as in the current design of Plunde. Further, a snooze function for the reminders was requested by some of the participants.Other improvement suggestions were related to the wording or labelling of the features and functions in Plunde. Further, 1 participant suggested that the command labelled “change” in the personal notes feature would be more understandable if labelled “change text.” Another participant suggested renaming the feature “information” which relates to evidence-based knowledge and guidelines regarding lifestyle. The label “information” was perceived to wrongfully be understood as information about PlundeLastly, to aid in the navigation of Plunde, several of the participants suggested a help feature or alternatively a separate written manual. In this connection, 1 participant expressed that an app should be so intuitive that there would be no need for a help feature. | PMC10687681 | ||
Discussion | PMC10687681 | |||
Principal Findings | DM2 | MINOR | The aim of this study was to assess the usability of an app developed to promote initiation of behavioral change and adherence to healthy behavior in people at risk of DM2. In general, only minor changes to the functionality of Plunde was reported as necessary to improve the usability. The most critical improvement included how to delete a message as this was difficult for all except one. This function is considered as crucial since it is important to maintain control over your own data. The participants are told not to share any sensitive information; however, it may also happen that they share something else that they later on would like to delete for some reason. To make the design consistent, deleting a message and deleting a note has therefore been changed so these 2 commands are the same (swiping right). Additionally, a trashcan symbol has been added in addition to the text “delete.” Other improvements made based on the TA-sessions included how to save notes and renaming of the feature “information.” As suggested by some of the participants, the command saving has been moved to a more obvious place (right top of the interface) and a symbol for saving has been added as well. The feature “information” was suggested to be changed to “inspiration.” Since this word does not cover the intended content, the new label “knowledge assembly” was landed on after a discussion in the research group. To further improve the usability by making the design more appealing, small changes such as colors and icons have been made.Based on the results, finding and changing reminders that are linked to the tasks also should be considered to be changed. However, as Plunde will be used in research where it is not desirable for participants to change goals, tasks, or reminders throughout an intervention period, we have chosen not to change this function at this time. Before implementation of Plunde to clinical practice, this should be considered to increase the usability. Some of the findings from this TA study were not relevant to the upcoming small scale RCT feasibility study but might have to be considered in potential upcoming studies as well as for the implementation of Plunde. | PMC10687681 |
Strengths and Limitations | The sample of this study may seem small. However, previous studies have established that 80%-90% of the usability issues of web sites and apps can be detected in samples of 5 to 9 participants [The TA method has been criticized because of the high degree of self-reported data, which may jeopardize the validity of this study [ | PMC10687681 | ||
Future Research | DM2 | It remains an open question how quickly test persons would adapt to the design and features of Plunde and how satisfied they would be when using it over a longer period of time. These questions are intended to be answered by an upcoming feasibility RCT where the aim is to investigate how a future full scale RCT can be conducted. For the feasibility study, we plan to include 60 participants into three study arms: (1) Plunde app, (2) lifestyle intervention at a Healthy Life Centre (usual care), or (3) Plunde app + lifestyle intervention at a Healthy Life Centre. The primary outcome in this study is feasibility and criteria for success will be preset. If Plunde turns out to be feasible, we will consider testing it further for effect on bodyweight (primary outcome) in a full-scale RCT in people at risk of DM2. | PMC10687681 | |
Conclusions | Feedback from the participants gained through the TA-sessions and the postactivity interviews indicated their preferences for Plunde. In general, participants were satisfied with the usability of Plunde. By asking participants to navigate through, and comment on the features in Plunde as described in the problem-solving tasks, the researcher gained real time perspective on the appeal, relevance, and utility of Plunde. This has been translated into a refined version of Plunde that will be used in a feasibility study as described.The authors would like to express their gratitude to the people who participated and made this study possible. We confirm that all personal identifiers have been removed or disguised so that those described are not identifiable and cannot be identified. This project was internally funded by Oslo Metropolitan University.Conflicts of Interest: None declared.Interview guide, post-activity interview. | PMC10687681 | ||
Abbreviations | type 2 diabetes mellitusmobile healthPeople | type 2 diabetes mellitusmobile healthPeople Living Under changepostcardiac rehabilitationrandomized controlled trialthink aloud | PMC10687681 | |
Introduction | Soccer is likely the most popular team sport, with over 265 million FIFA-registered players worldwide [Sports nutrition aims to satisfy energy and nutrient demands while optimizing physiological adaptations and guaranteeing recovery [In general, body composition, endocrine environment, immune response, and cognitive function may be influenced by energy intake management [There are different methods and types of nutritional intervention strategies that can be used with populations. For instance, controlled diets indicate what to eat each day or provide menu and food mix options for different intakes without the possibility of making changes. On the other hand, exchange diet systems offer different alternatives based on food exchange lists that approximately contribute the same macronutrient value and energy. They can be exchanged in meal planning without significant differences in dietary intakes, providing subjects greater flexibility [To promote adherence to optimal nutritional habits in female soccer players, the design and implementation of a nutritional intervention requires | PMC10681300 | ||
Methods | PMC10681300 | |||
Participants | The study included 19 female elite soccer players who voluntarily participated and were divided into two groups: the “controlled-diet group” (CG) (n = 10; 19 ± 1.4 years; 63.6 ± 10 kg; 164 ± 2.0 cm) and the “exchange-diet group” (EG) (n = 9; 22.5 ± 4.8 years; 61.3 ± 7 kg; 164 ± 0.1 cm). A simple randomization was performed by generating a table of random numbers without repetition. Even numbers were assigned to the CG and odd numbers to the EG. All participants belonged to the same Spanish team and performed the same training program, which included 8 hours per week of practice and one official match per week. During the intervention players were not allowed to engage in any other training, to follow a different nutritional plan or to use any ergogenic aid that could affect the results. Prior to the start of the intervention, the players were fully informed about the purposes and risks of the study and provided written informed consent. They also completed a form with their personal, medical, and training details. The research project was conducted in accordance with the Declaration of Helsinki and was approved by the University Review Board for use of Human Subjects (Code: UEMC 10_2021) ( | PMC10681300 | ||
Participants flow diagram. | PMC10681300 | |||
Design and procedures | A cross-sectional study was designed to evaluate the dietary intake and NK during the competitive season in elite female soccer players. On the other hand, an experimental randomized controlled trial was designed to compare the effects of two different 12-week nutrition education interventions on NK, adherence, anthropometric data, physical performance, and biochemical indices. The intervention was performed at the start of the second part of the competitive season, and all the tests were conducted at two times points: pre-intervention (PRE) (i.e., one week before the start of the intervention) and post-intervention (POST) (i.e., one week after the end). Dietary intake was only recorded at PRE.After baseline assessments, participants were informed about their specific nutritional plan. The main researcher conducted the educational session (60 minutes) in a relaxed atmosphere using a slide keynote focused on the importance of nutrition for soccer performance and explaining the specific intervention on each group. Both group diets were designed to provide the same amount of energy (Kcal) and nutrients (PROT, CHO and fat) at a similar timing. Total energy needs were calculated taking into account the average weight of the players in the study (60 kg) (42 ± 3 Kcal·kgBM | PMC10681300 | ||
Energy and nutritional diet distribution during the intervention (CG and EG). | *(lunch in this Mediterranean population)During the intervention, CG followed a diet consisting of pre-established menus and food combinations. Each day, players had to select one option from four different breakfasts, seven snacks/lunches, seven main meals and seven dinners. They were not allowed to substitute any food or ingredients. They were encouraged to vary their choices from the pre-established menu options. Different options were equivalent among them. In contrast, EG players were given exchange lists and instructed to create their own menus within the specified guidelines. The exchange list included food equivalents that could be swapped out for each other. The exchange list included CHO and PROT equivalents which provided a consistent amount of nutrients per serving: the exchangeable CHO equivalents provided 10 g of CHO, while the exchangeable PROT equivalents provided 7 g of PROT. EG players were able to make daily adjustments to their menus and exchange food and ingredients as needed. Fats and oils used in the cooking and dressings were not included in the dietetic indications because the general recommendations were the same in both groups. During the entire intervention, all subjects had access to a professional nutritionist to address any related questions. | PMC10681300 | ||
Measures | PMC10681300 | |||
Dietary intake, nutritional knowledge and adherence questionnaires | Dietary intake was measured using a 7-day food record sheet that included the day of competition (Sunday), and the day before (Pre-competition, Saturday) and five weekdays (Monday to Friday) [NK was assessed using the General Nutrition Knowledge Questionnaire (NKQ) [ | PMC10681300 | ||
Anthropometric measurements | All the anthropometric measurements were taken in accordance with the standardized procedures of the International Society for the Advancement in Kinanthropometry [ | PMC10681300 | ||
Physical performance | Running speed and vertical jump performance were assessed 2 days before and after the intervention to analyze the diet-induced effect. After a protocolled warm-up, participants were requested to perform 3 repetitions of a 20-m maximum sprint, starting from a total static position 1 m behind the start line on the competitive surface (i.e., artificial turf) with the competitive equipment (i.e., soccer cleats) using two photocell gates (Racetime2, Microgate, Italy) [ | PMC10681300 | ||
Biochemical analysis | BLOOD | Blood analyses were performed 2 days before and after intervention at the same time of the day in a fasted and rested state. Data were obtained using an electronic hematology analyzer (Sysmex–SE9500, TOA Medical Electronics, Kobe, Japan). The outcomes measured were haemoglobin and hematocrit level, urea, iron, transferrin, transferrin saturation index, ferritin, vitamin B12, vitamin D25 –OH and cortisol. The evaluation was based on the reference range (Table 3) indicated by the biochemical analysis laboratory. | PMC10681300 |
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