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This Study | EMA | To evaluate these changes, we implemented 2 randomized controlled trials (RCTs) within the ongoing Health@NUS study. The practical nature of these nested RCTs (ie, to act to improve overall EMA survey response rate in an ongoing study) meant that publishing a protocol before starting the study was not feasible. The outcome variable (response rate) was specified Flow of participants through the nested randomized controlled trials. HP: Health Points. | PMC10623229 | |
Participants | word of mouth | RECRUITMENT, RECRUITMENT, EMA | Participants were recruited to Health@NUS via email, campus posters, and word of mouth. To be eligible, participants had to (1) be a full-time student at the NUS, (2) be aged 18 to 26 years, (3) be a citizen or permanent resident of Singapore, and (4) own a smartphone compatible with the study app (ie, minimum iOS 10 or Android 7). Recruitment was ongoing at the time of writing this paper.There were no additional eligibility criteria for this study. A total of 384 students who joined Health@NUS during the first wave of recruitment between October 2020 and March 2021 were included. During study enrollment, participants provided written informed consent to receive short surveys (EMAs, <10 min each) via the study app (HiSG app). Participants were advised that the EMA surveys were optional but highly encouraged and that they would be compensated for answering them. No specific details of the survey timing, frequency, or the compensation were provided during the consent process. | PMC10623229 |
EMA Details | PMC10623229 | |||
Burst 1 of EMA Surveys | GROUP B, EMA | Before burst 1 (baseline), the participants received an email to notify them of the upcoming EMA burst. A second reminder email and one push notification reminder were sent midway through the EMA burst (see the left-hand side of During burst 1, all participants received 42 EMA surveys over 10 days within a 14-day period (see the left-hand side of Overview of general reminders sent before and during each ecological momentary assessment (EMA) burst. Reminder sent via email (E), text message (T), or push notification (P). Group A: 25 Health Points (HP) per completed EMA survey. Group B: 25 HP per completed EMA survey + bonus HP available. Group C: 50 HP per completed EMA survey. Group D: 50 HP per completed EMA survey + bonus HP available. An additional 2 push notifications are sent per EMA survey (first push notification, second push notification 25 min later, if survey remains unanswered).FIG2OV~1.PNGd.Overview of the 14- and 7-day ecological momentary assessment (EMA) schedules. The black dot indicates that an EMA survey was sent on this day in this time window. Surveys were sent at random times within the following time windows: survey 1 (8:30-9:30 AM), survey 2 (11 AM to noon), survey 3 (1:30-2:30 PM), survey 4 (4-5 PM), survey 5 (6:30-7:30 PM), survey 6 (9-10 PM). Burst 1 and 2: all participants (N=384) received the 14-day EMA schedule (burst 1: 42 EMA surveys and burst 2: 41 EMA surveys as survey 6 on day 9 was not sent due to a technical glitch). Burst 3: intervention group participants (n=288) received the 7-day schedule (30 EMA surveys), and control group participants (n=96) received the 14-day schedule (42 EMA surveys). | PMC10623229 | |
Burst 3 of EMA Surveys | EMA | The original 14-day schedule was condensed into 7 days, and the overall number of EMA surveys was reduced to 30 (see the right-hand side of Before the start of burst 3, participants received an SMS text message (instead of an email) notifying them of the upcoming EMA burst plus they received an SMS text message every 3 days to remind them to complete the EMA surveys (total number of SMS text messages sent/participant: 5 for those receiving a 14-d schedule and 3 for those receiving a 7-d schedule [The second nested RCT aimed to evaluate whether a condensed EMA schedule would achieve a higher response rate (hereafter referred to as | PMC10623229 | |
Measures | EMA | At baseline, participants self-reported their age (date of birth); sex (male or female); ethnicity (Chinese, Indian, Malay, or Other); marital status (single or never married, currently married, separated but not divorced, divorced, widowed, or refuse to answer); monthly household income (<SG $2000 [US $1466], SG $2000-SG $3999 [US $1466-US $2932], SG $4000-SG $5999 [US $2933-US $4398], SG $6000-SG $9999 [US $4399-US $7331], >SG $10,000 [>US $7332]), refuse to answer, or do not know); whether they are an undergraduate or postgraduate student; and the faculty they are studying in.Biometric assessments (height in cm and weight in kg) were taken by trained study personnel. BMI was calculated from height and weight measurements and classification recommendations for Asian populations [EMA surveys were administered via the HiSG app, and responses were automatically captured by the app and uploaded to a study server in real time. | PMC10623229 | |
Primary Outcome | EMA | The primary outcome measure was the response rate (ie, percentage of completed EMA surveys from all sent EMA surveys) for each burst of EMA surveys. | PMC10623229 | |
Statistical Methods | EMA | Baseline characteristics were analyzed descriptively. Separate 1-way ANOVAs were used to estimate the effect of changing the reward structure (aim 1, reward RCT) or the schedule length (aim 2, schedule length RCT) on the response rate at burst 2 and burst 3, respectively. A sensitivity analysis was conducted using analysis of covariance to adjust for the response rate at burst 1 (ie, baseline).Secondary aim 3 was first analyzed using linear mixed model analysis with restricted maximum likelihood estimation to compare the overall response rate across the 3 bursts of EMA surveys following changes to the EMA implementation protocol (illustrated in | PMC10623229 | |
Ethical Considerations | EMA | Ethics approval was obtained from the National Healthcare Group in Singapore (reference 2019/00285). All participants provided written informed consent before commencing the study and consented for their deidentified data to be used for research purposes. For this study, the maximum compensation available to participants ranged from SG $21 (US $15) to SG $34.66 (US $25) depending on group allocation during the reward RCT and on the number of EMA surveys they completed. | PMC10623229 | |
Results | PMC10623229 | |||
Participant Flow | EMA | Between October 2020 and March 2021, 384 participants were recruited and enrolled into this study, and data collection was complete by October 2021.Following burst 1 and before burst 2, the participants were randomized to group A (n=96), group B (n=95), group C (n=96), or group D (n=97). Following burst 2 and before burst 3, participants were randomized to the intervention (7-d EMA schedule, n=288) or control (14-d EMA schedule, n=96) group. | PMC10623229 | |
Discussion | PMC10623229 | |||
Principal Findings | SECONDARY, EMA | This study experimentally evaluated the effect of rewards and schedule length on EMA response rates within the context of an ongoing study implementing repeated bursts of EMA surveys. Reducing the number of days of EMA surveys led to a significantly lower response rate. However, changing the available rewards did not significantly change the response rate. Overall, for all groups the response rate was lowest at baseline (burst 1) as compared with the subsequent bursts of EMAs and the difference was statistically significant. However, our subgroup analysis that was intended to further explore whether this was because of changes in how participants were notified of the relevant burst of EMA surveys found no significant difference in the response rate at each burst.The response rate to burst 1 was very low, prompting this study, and increased substantially in burst 2 and burst 3 in all groups. It is possible that the initial low response rate was because the upcoming EMA burst was not well communicated to the participants. Future bursts included more frequent communication delivered directly to all participants (via SMS text messages and push notifications). These simple changes may have contributed to the increased response rate. However, we did not experimentally evaluate the effects of these communication changes. Our secondary analysis partially supported this finding, as there were significant differences between the response rate at each burst. However, in the subgroup analysis of the control group participants, the differences were no longer significant. | PMC10623229 | |
Findings in Context | EMA | The finding that neither offering greater reward amounts nor reducing the schedule length led to an increase in the response rate is broadly consistent with systematic reviews of factors associated with EMA compliance [Rewards were selected as the first intervention target as the rewards available in burst 1 were low compared with other studies; participants could receive a total of approximately US $5 for completing all the EMA surveys. In other studies with a similar number of EMA days (between 10 and 14 d) and surveys (between 35 and 50 surveys), the lowest incentive was approximately US $25 [In our study, contrary to our expectations, the burst 2 response rate was significantly higher in the 14-day schedule group than in the shorter 7-day schedule group. It seems intuitive that fewer days of EMA surveys would be less intrusive and therefore preferable to participants, particularly in the context of repeated bursts of EMA surveys. However, our findings indicate the opposite. More research is needed in this area as systematic reviews currently report inconsistent relationships between EMA schedule length and response rate [Although the average response rate in EMA studies has been reported to be >70% [ | PMC10623229 | |
Strengths and Limitations | HOLIDAYS, SECONDARY, BLIND, EMA | The strengths and limitations of this study should be considered. Our RCTs were embedded within an ongoing cohort study that required participants to fulfill several mandatory requirements (eg, minimum Fitbit wear time and food diary logging/mo), whereas completing the EMA surveys was optional but highly encouraged, and participants may have decided to opt out of this study component. Furthermore, although our sample size was larger than that of many other EMA studies [Our pragmatic approach also meant that our secondary aim, to explore temporal changes in the response rate, was exploratory in nature. Future studies specifically designed to experimentally evaluate the effect of altering the announcement and communication strategy for each EMA burst (ie, the number of emails, SMS text messages, and push notifications that were sent to provide details of what to expect in the upcoming burst of EMA surveys) are needed. Studies evaluating the effects of other temporal variables such as holidays and key periods in the academic calendar (eg, exams) are also needed. As is typical of behavioral research, it was not possible to blind participants to their intervention condition, and we also cannot comment on whether participants received all of the EMA surveys that were sent. Furthermore, in our study, the number of EMA surveys per day varied (3-6/d), which may have lowered the response rate as participants did not know when to expect a survey. Finally, our sample consists of university students who may be especially motivated to engage in health research and therefore may not be representative of the broader population of young adults. The extent to which our findings generalize beyond this group is unclear. However, as young adults are a key population studied in EMA studies [ | PMC10623229 | |
Conclusions | EMA | This study is one of the first to experimentally evaluate the effect of incentives and schedule length on EMA response rates. It is also the first study to consider factors related to response in the context of an ongoing prospective cohort study administering repeated bursts of EMA over a 2-year period. By embedding RCTs within an ongoing study, it was possible to rapidly implement and evaluate whether altering the implementation strategy, incentives, or schedule length would increase the response rate. Our study therefore contributes to a small but growing body of literature on how to implement EMA. This knowledge is essential for collecting high-quality EMA data, which has a flow-on effect to the quality of conclusions that can be drawn from these data.This study was funded by the Health Promotion Board of the Singapore Government. The funder had no role in the analysis, interpretation of the data, or the decision to submit the manuscript for publication.Reporting of these nested trials followed the CONSORT (Consolidated Standards of Reporting Trials) extension for the reporting of randomized controlled trials conducted using cohorts and routinely collected data (Authors' Contributions: KC, RMvD, and FM-R secured study funding. All the authors made substantial contributions to the study design. AL and XHC were responsible for data acquisition. CMJLG, RMvD, CST, FM-R, and SME planned the data analysis. CMJLG performed the data analysis with input from CST and SME. SME drafted the manuscript. All authors critically reviewed the manuscript and approved the final version.Conflicts of Interest: SME, CMJLG, XHC, RMvD, CST, and FM-R declare no competing interests. AL, JC, DK, and KC declare no competing financial interests, but they are current employees at the Singapore Government Health Promotion Board.Overview of the 14- and 7-day ecological momentary assessment schedules including number of questions sent per ecological momentary assessment survey.Constructs assessed via Ecological Momentary Assessment surveys—example questions and response options.Per day response rate for each burst of Ecological Momentary Assessment surveys.CONSORT-ROUTINE (Consolidated Standards of Reporting Trials extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data) checklist.CONSORT-EHEALTH checklist. | PMC10623229 | |
Abbreviations | Consolidated Standards of Reporting Trialsecological momentary assessmentHealth PointsNational University of Singaporerandomized controlled trial | PMC10623229 | ||
Data Availability | Deidentified data that support the findings of this study may be available from the corresponding author (SME) upon reasonable request. | PMC10623229 | ||
Key Points | PMC9926359 | |||
Question | Does a dosage of 1000 IU per day compared with 400 IU per day of supplemental vitamin D in infants born with serum 25-hydroxyvitamin D concentrations less than 50 nmol/L (ie, 20 ng/mL) present advantages to bone outcomes throughout infancy? | PMC9926359 | ||
Findings | SECONDARY | In this prespecified secondary analysis of a double-blinded randomized clinical trial including 139 healthy term infants, whole-body bone mineral content, lumbar spine bone mineral content and density, and bone biomarkers were not different among dosage groups from age 1 to 12 months. | PMC9926359 | |
Meaning | SECONDARY | This study supports a standard daily supplemental dose of 400 IU of vitamin D in breastfed infants in Montreal, even if born with serum 25-hydroxyvitamin D concentrations less than 50 nmol/L.This prespecified secondary analysis of a randomized clinical trial evaluates whether a higher dose of supplemental vitamin D (1000 vs 400 IU per day) is required in infants born with 25-hydroxyvitamin D (25[OH]D) concentrations less than 50 nmol/L for bone mineral accretion across infancy. | PMC9926359 | |
Importance | The dose of supplemental vitamin D needed in infants born with serum 25-hydroxyvitamin D (25[OH]D) concentrations less than 50 nmol/L (ie, 20 ng/mL) is unclear. | PMC9926359 | ||
Objective | To determine whether a higher dose (1000 IU vs 400 IU per day) is required in infants born with 25(OH)D concentrations less than 50 nmol/L for bone mineral accretion across infancy. | PMC9926359 | ||
Design, Setting, and Participants | SECONDARY | In this prespecified secondary analysis of a double-blinded randomized clinical trial, conducted from March 2016 to March 2019 in a single center in Greater Montreal, Quebec, Canada, a consecutive sample of 139 healthy term singletons were recruited from 866 infants screened for vitamin D status at birth. Data were analyzed from June 2021 to November 2022. | PMC9926359 | |
Interventions | Capillary blood was collected 24 to 36 hours after birth to measure serum total 25(OH)D concentrations. Infants with 25(OH)D concentrations less than 50 nmol/L were randomized to receive either 1000 IU or 400 IU per day of oral vitamin D | PMC9926359 | ||
Main Outcomes and Measures | Measures at age 1, 3, 6, and 12 months were preplanned and included whole-body bone mineral content, lumbar spine bone mineral content, and bone mineral density using dual-energy x-ray absorptiometry, and serum 25(OH)D | PMC9926359 | ||
Results | Of 139 included infants, 81 (58.3%) were male, and the median (IQR) gestational age at birth was 39.6 (38.9-40.6) weeks. A total of 49 infants were included in the 1000 IU per day group, 49 infants in the 400 IU per day group, and 41 in the reference group. Mean (SD) whole-body bone mineral content was not different between trial groups over time (1000 IU per day, 173.09 [2.36] g; 400 IU per day, 165.94 [66.08] g). Similarly, no differences were observed in lumbar spine bone mineral content or density. Mean (SD) serum 25(OH)D | PMC9926359 | ||
Conclusions and Relevance | In this study, a higher dose of vitamin D supplementation in infants born with 25(OH)D concentrations less than 50 nmol/L did not present advantages to bone mass in infancy. This study supports a standard dose of 400 IU per day of vitamin D supplementation for breastfed infants in Montreal. | PMC9926359 | ||
Trial Registration | ClinicalTrials.gov Identifier: | PMC9926359 | ||
Introduction | Vitamin D status at birth reflects maternal-fetal transfer of 25-hydroxyvitamin D (25[OH]D).A dose-response relation exists between vitamin D intake and 25(OH)D concentration in infants, and the lower the initial concentration, the greater the rise in vitamin D status.The objective of this study was to compare the effect of 1000 IU per day of oral vitamin D supplementation vs 400 IU per day on bone health from age 1 to 12 months in infants born with serum 25(OH)D concentrations less than 50 nmol/L and whose mothers had an intent to breastfeed for at least 3 months. Our hypothesis was that infants born with serum 25(OH)D concentrations less than 50 nmol/L and provided with a supplement of 400 IU per day (compared with 1000 IU per day) would have lower bone mineral accretion by 3 months without resolution at age 12 months. | PMC9926359 | ||
Methods | PMC9926359 | |||
Study Design | SECONDARY | This was a prespecified secondary analysis of a double-blinded, parallel group randomized clinical parallel group trial conducted in Montreal, Quebec, Canada, from March 2016 to March 2019 and followed the Consolidated Standards of Reporting Trials ( | PMC9926359 | |
Participant Flow Diagram | LGA | RECRUITMENT | Participant flow diagram showing number of mother-infant dyads assessed for eligibility 24 to 36 hours after delivery, enrolled to newborn screening, screened, enrolled to the postnatal study, and allocated to either the trial group (serum 25-hydroxyvitamin D (25[OH]D) concentrations less than 50 nmol/L [ie, 20 ng/mL]) or reference group (serum 25[OH]D concentrations of 50 nmol/L or more). Infants allocated to the trial group were randomized to receive either 400 or 1000 IU per day. Infants in the reference group received 400 IU per day. Sample size per group at each time point reflects the number analyzed for biomarkers and the number of whole-body (WB) and lumbar spine (LS) scans available at each study visit are reported. LGA indicates large for gestational age; SGA, small for gestational age.Ethical approval was obtained from St. Mary’s Hospital Research Ethics Committee, which oversees research ethics for the Lakeshore General Hospital (SMHC-15-34), where newborn recruitment took place. The study was also reviewed and approved by Health Canada Research Ethics Board (REB 2019-033H) and Privacy Management Division (HC-PR-2019-000024). Written consent was obtained from the parents at the newborn screening and the baseline visit. The trial was conducted at the Mary Emily Clinical Nutrition Research Unit, McGill University, Sainte-Anne-de-Bellevue, Quebec, Canada. | PMC9926359 |
Bone Outcomes | Whole-body (WB) and lumbar spine (LS) vertebrae L1 to L4 BMC and BMD were measured using dual-energy x-ray absorptiometry methodology, as described elsewhere. | PMC9926359 | ||
Biochemistry | BLOOD | Blood samples from the infants and their mothers were collected, as previously reported.In infants at birth, serum total 25(OH)D concentrations were measured using an automated chemiluminescent immunoassay (LIAISON analyzer; DiaSorin), as previously reported,During the trial, infant serum (200 μL) was used to measure 25(OH)DPlasma procollagen type 1 N-terminal propeptide (P1NP; Human P1NP ELISA; Creative Diagnostics) and urinary alpha telopeptide of type 1 collagen (CTX-I; EIA; Immunodiagnostic Systems) were measured as recommended | PMC9926359 | |
Dietary and Lifestyle Data | At baseline, maternal nutritional intake (energy, protein, carbohydrates, fat, vitamin D, calcium, magnesium, and phosphorus) during pregnancy from food and supplements was assessed using a validated semiquantitative food frequency questionnaire, | PMC9926359 | ||
Statistical Analysis | REGRESSION, SKIN, SECONDARY | This analysis is the secondary objective of the trial. The primary objective was focused on lean mass outcomes, with the aim of recruiting a minimum of 46 infants per trial group and up to 74 to account for dropouts.Differences between the trial groups over time in bone outcomes (dual-energy x-ray absorptiometry and biomarkers), vitamin D metabolites, and safety biomarkers (iCa, urinary calcium to creatinine ratio, and urinary phosphate to creatinine ratio) were tested using linear mixed-effects regression models with participant-level random intercepts and slopes for time. We used a first-order autoregressive covariance structure selected based on the correlation matrix and the lowest Akaike information criterion. The variables included group-by-time interaction, time, and participant number. Skin pigmentation, UV-B period and season at birth, infant sex, and socioeconomic and demographic characteristics were explored but not retained in the model. Data were not imputed given that the mixed-effects model used all available data, and data were assumed to be missing at random.A post hoc analysis of covariance tested differences between the trial groups in bone outcomes (WB BMC, LS BMC, and LS BMD) with corresponding baseline values for each dependent variable tested as covariates. In these models, the repeated measures were at 3, 6, and 12 months.All statistical analyses were conducted using SAS University Edition (SAS Institute), and statistical significance was set at | PMC9926359 | |
Results | Characteristics of infants and their mothers are provided in the | PMC9926359 | ||
Characteristics at Birth and at Baseline | weight gain | REGRESSION | Abbreviations: BMI, body mass index; ITA, individual typology angle; 24,25(OH)Seasons are based on equinox and solstice dates for each year.Serum 25(OH)D concentrations measured using chemiluminescent immunoassay and standardized using Deming regression (standardized concentration [in nmol/L] calculated as 0.9634 [measured concentration] + 3.122).Measured using liquid chromatography–mass spectrometry/mass spectrometry.Gestational weight gain categories were classified according to pregravid BMI using the Institute of Medicine classification.Calculated as weight in kilograms divided by height in meters squared.Mothers self-reported their own race, as described in detail elsewhere.WB BMC, WB BMC per kilogram bodyweight or BMC per centimeter, LS BMC, and LS BMD were not different between groups across the trial ( | PMC9926359 |
Whole-Body Bone Mineral Content (BMC), Lumbar Spine BMC, and Lumbar Spine Bone Mineral Density (BMD) of Infant Groups Over Time | REGRESSION | Data are reported as means with SDs and were analyzed using a linear mixed-effects regression model for group-by-time interaction and time; the model included participant-level random intercepts and slopes for time. Post hoc testing showed no significant differences between trial groups over time adjusted for multiple comparisons except for time, which was significant for all comparisons. A total of 469 whole-body scans and 484 lumbar spine scans were obtained of a possible 489 across all time points. The remaining were not obtained or analyzed due to movement artifacts. The shaded areas correspond to the reference group SDs.Serum 25(OH)D | PMC9926359 | |
Biomarkers of Calcium and Bone Metabolism of Infant Groups Over Time | REGRESSION | Data are reported as means with SDs and were analyzed using a linear mixed-effects regression model for group-by-time interaction and time; the model included participant-level random intercepts and slopes for time. Post hoc testing showed no differences between trial groups over time. The 1000 IU per day group and 400 IU per day group were adjusted for multiple comparisons except for time, which was significant for all comparisons. The shaded areas correspond to the reference group SDs. CTX-I indicates urinary alpha telopeptide of type 1 collagen; P1NP, procollagen type 1 N-terminal propeptide; PTH, parathyroid hormone. | PMC9926359 | |
Discussion | SECONDARY | In the absence of robust trials investigating the effect of a dose of vitamin D supplementation higher than the standard of care (400 IU per day) on bone mineral accretion and density in infants born with 25(OH)D concentrations less than 50 nmol/L, this prespecified secondary analysis of a randomized clinical trial provides information to help guide recommendations for vitamin D supplementation in this understudied population. Infants at elevated risk of insufficient vitamin D status provided with a daily supplement of 400 IU (compared with 1000 IU per day) did not have compromised bone outcomes (WB BMC, LS BMC, or LS BMD) across infancy. This is in line with findings from a study by Ziegler et al,The results of this study and othersIn accordance with no evidence of a dose-response in bone mass with vitamin D supplementation and achievement of sufficient vitamin D status, no differences in biomarkers of bone formation or resorption due to vitamin D dose were noted in our trial from age 1 to 12 months. These markers lack reference data in infancy, and efforts to standardize biomarkers of bone metabolism are needed.Serum 25(OH)DThe lack of dose-response of 1,25(OH) | PMC9926359 | |
Strengths and Limitations | Strengths of this study are its design that implemented targeted entrance criteria on the basis of serum 25(OH)D concentrations less than 50 nmol/L at birth and that it provides valuable data on bone mass, calcium homeostasis, and multiple vitamin D metabolites in infancy. This study also has limitations. Outcomes were measured using criterion standards for assessment of bone mass and vitamin D status. | PMC9926359 | ||
Conclusions | In conclusion, in infants with 25(OH)D concentrations less than 50 nmol/L at birth, both 400 and 1000 IU per day of vitamin D supplementation normalized and maintained 25(OH)D concentrations that align with skeletal health. The 1000 IU per day dosage of vitamin D supplementation did not lead to measurable improvements in bone health outcomes. Evidence from this Montreal-based study suggests that the standard of care of 400 IU per day is enough to support bone health of breastfed infants born with serum 25(OH)D concentrations less than 50 nmol/L. | PMC9926359 | ||
1. Introduction | obesity, obese, overweight, weight loss | OBESITY, OVERWEIGHT AND OBESITY, OBESE | Studies investigating the effect of multispecies synbiotic supplementation in obesity management are limited. The current study was performed to evaluate the effects of multispecies probiotics mixed with fructooligosaccharides on body composition, antioxidant status, and gut microbiome composition in overweight and obese individuals. We employed a randomized, double-blind, placebo-controlled trial design, in which 63 individuals aged 18–45 years were assigned to receive either a synbiotic supplement or placebo for 12 weeks. The synbiotic group consumed a daily dose of 37 × 10Overweight and obesity can be attributed to a complex interplay of multiple factors that result in a dysregulated energy balance in the body, leading to an abnormal accumulation of adipose tissue or body fat. The prevalence of overweight and obesity has been recognized as a common epidemic and a crucial public health problem of the twenty-first century [Dietary interventions that include probiotics, prebiotics, or synbiotics (a combination of probiotics and prebiotics) have been discovered to restore the gut microbiota observed in obese individuals and promote weight loss and maintenance [Despite some evidence that synbiotics may help reduce obesity and its associated consequences, research on the effect of synbiotics with multiple probiotic species in overweight and obese participants is limited. Therefore, the current study seeks to evaluate the impact of a specific multispecies synbiotic supplement, containing a blend of seven probiotic strains and fructooligosaccharides, on body composition, antioxidant levels, and gut microbiome composition in overweight and obese individuals. | PMC10141052 |
2. Materials and Methods | PMC10141052 | |||
2.1. Participants | The study recruited participants from Chulalongkorn University in Bangkok, Thailand, through social media advertisements. Inclusion criteria for participants were: (1) being between the ages of 18 and 45, and (2) having a body mass index (BMI) between 23 and 30 kg/m | PMC10141052 | ||
2.2. Study Design | overweight | OBESE | A double-blind, placebo-controlled, randomized, parallel design was conducted on overweight and obese individuals between March 2021 and January 2022 at Chulalongkorn University in Bangkok, Thailand. The total sample size required for this study was calculated to be In the current study, a total of 80 individuals were enrolled for screening, but only 72 of them successfully completed the screening process. Participants were randomly assigned to either a placebo ( | PMC10141052 |
2.3. Body Composition Assessment | Body weight, body mass index (BMI), and body fat percentage were assessed using bioelectrical impedance analysis (BIA) (TANITA BC-402, Tokyo, Japan) while participants were dressed in light clothing and no shoes [ | PMC10141052 | ||
2.4. Biochemical Assessment | BLOOD, OXIDATIVE STRESS | We collected venous blood samples using sodium fluoride and EDTA blood collection tubes for plasma samples and no anticoagulant tubes for serum samples. Blood samples were centrifuged at 3000 rpm for 15 min at 4 °C, and the plasma and serum were aliquoted and stored at −20 °C for further analysis. Plasma glucose, serum lipids, and kidney and liver function were analyzed by the Health Science Unit, Faculty of Allied Health Sciences, Chulalongkorn University, Thailand. Plasma antioxidants (TEAC) and plasma oxidative stress markers such as thiol and MDA (malonaldehyde) were evaluated at the phytochemical research unit, Chulalongkorn University, Thailand. The plasma Trolox equivalent antioxidant capacity (TEAC) was measured by the 2,2′-azinobis (3-ethylbenzothiazoline-6-sulfonate) free radical (ABTS●+) (Merck KGaA, Darmstadt, Germany) solution [The plasma protein thiol level was determined using a modified Ellman’s assay [The plasma MDA level was determined using a TBARS-based method [ | PMC10141052 | |
2.5. Gut Microbiome Analysis | Stool samples were obtained from all participants, who were instructed to self-collect the specimens at home. Stools (100 g) from each participant were collected and stored at −80 °C in tubes containing DNA/RNA Shield™ solution (Zymo Research, Irvine, CA, USA). Participants were also provided with a poster describing the procedure and a video demonstrating how to collect the stool sample. All samples must be collected one to two days before the visit. The container was verified using the participant’s label number and sent for analysis of the 16S rDNA gene amplicon using polymerase chain reaction (PCR). DNA was extracted from stool samples using ZymoBIOMICS | PMC10141052 | ||
2.6. Dietary Assessment | At baseline and at weeks 6 and 12 of the study, participants were asked to complete a three-day dietary record (two weekdays and one weekend day) to estimate calorie intake. Additionally, all participants were asked to complete a 24 h dietary recall to ensure they maintained their intake and to reduce any bias from the food record. Nutrient intake was analyzed using the nutrient analysis software INMUCAL, Version 4.0 (Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand) [ | PMC10141052 | ||
2.7. Statistical Analysis | Data are represented as mean ± standard deviation (SD). The Kolmogorov–Smirnov test was applied to ensure a normal distribution of body composition, biochemical blood profiles, and gut microbiota composition. A paired sample | PMC10141052 | ||
3. Results | PMC10141052 | |||
3.1. Participant Characteristics | Eighty participants were recruited for the study ( | PMC10141052 | ||
3.2. Body Composition Measurement | The consumption of synbiotics for 12 weeks resulted in a significant decrease in waist circumference ( | PMC10141052 | ||
3.4. Dietary Measurement | The results of the dietary assessment, conducted after subjects consumed synbiotics, are presented in | PMC10141052 | ||
4. Discussion | obesity, obese, Obesity-related metabolic disturbances, overweight, weight loss | OBESITY, OXIDATIVE STRESS, OBESE | Recent research has indicated that synbiotic interventions may be a promising approach for overweight and obesity management [The study highlights the potential benefits of a multispecies synbiotic intervention, combining probiotic bacteria (Changes in calorie intake can potentially impact alterations in waist circumference and body fat percentage among obese subjects. The findings showed that there were no significant differences in calorie intake, particularly in macronutrients, between the placebo and synbiotic groups. Therefore, decreased waist circumference and body fat percentage in the synbiotic group may not be directly attributed to changes in calorie intake. However, it is worth considering that the synbiotic intervention may have influenced the participants’ gut microbiome, leading to changes in energy metabolism and potentially promoting weight loss independent of calorie restriction.Studies have shown that modulating the gut microbiota can increase energy expenditure and reduce fat storage in overweight and obese individuals [The F/B ratio has been acknowledged to play a crucial role in maintaining intestinal homeostasis, and alterations in this ratio have been linked to various pathologies, including obesity [Obesity-related metabolic disturbances are strongly associated with an elevation in oxidative stress, which refers to an imbalance between the body’s ability to repair or neutralize the damage caused by reactive oxygen species (ROS) and their production [The present study has several strengths, including a clinical approach, an appropriate sample size for the research question, a sufficient treatment period to detect changes in antioxidant status, interventions that align with the typical daily habits of participants, and no reported side effects from the synbiotic treatment. Moreover, recruiting overweight and obese participants in this study can provide valuable insights into understanding the impact of synbiotic interventions on this population and contribute to developing more effective strategies to address obesity. The study will be relevant to a high-risk population, and the results will be more generalizable to a broader range of patients. In this study, we aim to assess the efficacy of multispecies probiotics in overweight and obese individuals. This approach differs from previous studies that have utilized multi-strain probiotics. Using multispecies probiotics confers a more diverse range of beneficial bacterial strains and promotes a more diverse gut microbiome, which may enhance gut health and overall well-being. Additionally, multispecies probiotics have the potential to provide a more comprehensive range of health benefits compared to single-strain probiotics. However, the study also has some limitations that should be acknowledged. One limitation is the lack of fecal physical examination measurements, which could have provided valuable information about the effects of synbiotic consumption on gut health. Additionally, changes in the bacterial flora were not evaluated for specific bacterial strains, which could have provided insight into the impact of the synbiotic treatment on the F/B ratio. In order to fully comprehend the impact of synbiotics on antioxidant capacity, further studies should focus on evaluating the influence of individual variations and the microbiome composition on the efficacy of treatment. | PMC10141052 |
5. Conclusions | The synbiotic treatment showed notable improvement in body composition (waist circumference and body fat percentage), antioxidant status, and gut microbiota ( | PMC10141052 | ||
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10141052 | ||
Author Contributions | Conceptualization, P.O., S.N., T.S. and S.A.; Data curation, P.O., P.C. and V.S.; Investigation, P.O., P.C. and V.S.; Methodology, P.O., T.S., S.P. and S.A.; Formal analysis, P.O., P.C., S.P., C.C. and V.S.; Supervisor, S.A. and T.S.; Writing—original draft preparation and writing—review and editing, P.O., T.S., C.C., S.P. and S.A.; Project administration, S.A., T.S. and C.C.; Funding acquisition, S.A., T.S. and S.N. All authors have read and agreed to the published version of the manuscript. | PMC10141052 | ||
Institutional Review Board Statement | COA No. | The study was approved by the office of the Ethics Review Committee for Research Involving Human Research Subjects, Human Science Group, Chulalongkorn University (COA No. 276/2563). | PMC10141052 | |
Informed Consent Statement | All participants provided written informed consent in this study. | PMC10141052 | ||
Data Availability Statement | The data presented in the manuscript are available on request from corresponding author. | PMC10141052 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10141052 | ||
References | overweight | OBESE | The CONSORT flow diagram of the study.Effect of 12-week synbiotic intervention on gut microbiota composition in overweight and obese subjects. (Percent relative abundance of dominant phylum across second treatment groups. (Principal coordinate analysis (PCoA) using Bray–Curtis distances demonstrates the beta diversity of the gut microbiome at the phylum level. Baseline vs. week 12 of (The effect of the 12-week synbiotic intervention on the Baseline characteristics of the participants.Values are represented as mean ± SD.Effect of 12-week synbiotic intervention on body composition in overweight and obese subjects.Values are represented as mean ± SD. Means in the same column with a different uppercase superscript (A: treatment effects) indicate a significant difference (Effect of 12-week synbiotic intervention on biochemical profiles in overweight and obese subjects.Values are represented as mean ± SD. Means in the same column with a different uppercase superscript (A, B: treatment effects) indicate a significant difference (Effect of 12-week synbiotic intervention on plasma antioxidant status in overweight and obese subjects.Values are represented as mean ± SD. Means in the same column with a different uppercase superscript (A, B: treatment effects) indicate a significant difference ( | PMC10141052 |
Abstract | PMC10291993 | |||
Objective | anal fistula | LYMPHOMA | In this study, we investigated the impact of Zibai ointment on wound healing by analyzing the expression levels of two key apoptosis‐related factors—B‐cell lymphoma 2 (Bcl‐2) and Bcl‐2‐associated X protein (Bax), in patients following surgery for anal fistula. | PMC10291993 |
Methods | We included 90 patients with anal fistulas who were treated in the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine. Patients were randomly assigned to receive treatment with Zibai ointment ( | PMC10291993 | ||
Results | The results of ELISA showed that on Day 21 after the surgery, the levels of Bcl‐2 and Bax in the Zibai ointment group were significantly different compared to the petroleum jelly group, with values of (60.11 ± 1.31) ng/mL and (7.05 ± 0.01) versus (83.79 ± 1.74) ng/mL and (6.00 ± 0.05) ng/mL, respectively ( | PMC10291993 | ||
Conclusion | fistula | We found that Zibai ointment effectively promoted wound healing in patients following anal fistula surgery, possibly by regulating Bcl‐2 and Bax apoptosis‐related factors.In this study, we found that Zibai ointment effectively promoted wound healing in patients after anal fistula surgery, possibly by regulating Bcl‐2 and Bax apoptosis‐related factors.
| PMC10291993 | |
INTRODUCTION | anal fistula, fistula | DISEASES | Common anorectal diseases like anal fistula can only be treated surgically. However, postoperative wound healing can be challenging and unpleasant due to the anatomical features of the lesion site and the surrounding area. Patients experience a great deal of discomfort due to the lengthy postoperative recovery period. Therefore, it is crucial to find efficient methods to improve wound healing following surgery for anal fistula. Clinical studies have shown that Zibai ointment is highly effective in the postoperative treatment of anal fistula. We designed this preliminary study to explore the potential effects of Zibai ointment on cell apoptosis in promoting wound healing. The details are reported in the following sections. | PMC10291993 |
MATERIALS AND METHODS | PMC10291993 | |||
Clinical materials | PMC10291993 | |||
Diagnostic criteria | anal fistula | The diagnostic criteria for anal fistula used in this study are based on the | PMC10291993 | |
Inclusion criteria | anal fistula, fistula, abnormal anal morphology and function | LOCAL INFILTRATION | (1) Patients who met the above diagnostic criteria for anal fistula; (2) Patient aged > 18 years and <60 years; (3) The surgical method used was conventional anal fistula resection; (4) All surgeries were performed under either local infiltration anesthesia or lumbar anesthesia; (5) Patients without previous history of anal fistula surgery, or abnormal anal morphology and function; (6) Patients who agreed to be treated with Zibai ointment and gave their signed informed consent. | PMC10291993 |
Exclusion criteria | allergic, perianal eczema, anal papilloma, malignant tumors, psychiatric | PERIANAL ABSCESS, GASTROINTESTINAL INFECTIONS, RECTAL POLYPS, ANAL FISSURE, MALIGNANT TUMORS, DISEASES, CHRONIC DIARRHEA | (1) Patients with other anal diseases, such as anal fissure, perianal abscess, perianal eczema, rectal polyps, anal papilloma; (2) Patients suffering from chronic diarrhea or other gastrointestinal infections; (3) Patients diagnosed with malignant tumors in the body; (4) Patients with diseases affecting vital organs such as heart, brain, liver, lung, kidney, or diagnosed with psychiatric illnesses; (5) Pregnant and lactating women; (6) Patients allergic to Zibai ointment; (7) Patients who underwent anesthesia and surgical procedures that were different from those for inclusion in this study, or with incomplete data that impacted the efficacy assessment. | PMC10291993 |
General data | The study was approved by Ethics Committee of the People's Hospital Affiliated to Fujian University of TCM. Written informed consent was obtained from all participants. (2020‐048‐02). Patients were randomly assigned to either the Zibai ointment group (Comparison of Gender and Age between the Two Groups. | PMC10291993 | ||
Methods | PMC10291993 | |||
Treatment methods | MYZZ, Z06106031, fistula | Surgical method: First, use a probe to gently probe along the direction of the fistula from the outer opening, pass through the entire fistula, and reach the inner opening. Cut all fistulas along the direction of the probe and open the entire length of the fistula. Make incisions on both sides of the skin of the open fistula, continue to deepen along the incision, and cut diagonally towards the deep part of the fistula to remove the entire fistula. The transverse section of the wound is V‐shaped. Patients in both groups received standard postoperative anorectal care, and the wound dressing was routinely changed on the second day after surgery. Patients were asked to avoid eating spicy and fried foods during treatment and maintain regular bowel movements. The Zibai ointment group received external application of Zibai ointment (People's Hospital Affiliated to Fujian University of TCM, MYZZ Z06106031) on the first day postsurgery, while the control group received external application of petroleum jelly (production license No.: Zhejiang Food and Drug Administration Equipment Production License No. 20100048). The wound healing time was recorded, and we compared the clinical efficacy between the groups. | PMC10291993 | |
Experimental methods | We collected granulation tissue samples from both groups on Days 7, 14, and 21 postsurgery to analyze Bcl‐2 and Bax levels using enzyme‐linked immunosorbent assay (ELISA) and to measure granulation tissue apoptosis using the TUNEL assay.We used Human B lymphocytoma‐2 (Bcl‐2) ELISA kit (enzyme immunoassay, MM‐0381H1) B lymphocytoma‐2 associated X protein (Bax) ELISA kit (enzyme immunoassay, MM‐1143H1), and the TUNEL cell apoptosis kit (Beyotime, C1098). | PMC10291993 | ||
ELISA method for detecting the expression of Bcl‐2 and Bax | An appropriate amount of tissue was collected for later use after removal of blood, and weighed and transferred into a glass homogenizer. The tissue was rinsed with 5–10 mL of precooled PBS (0.01 M, pH = 7.4) to eliminate any residual blood and then ground thoroughly. The prepared homogenate was centrifuged at 5000 | PMC10291993 | ||
TUNEL assay for assessing cell apoptosis in granulation tissue postsurgery | The granulation tissue was prepared for apoptosis detection by fixing it, embedding in paraffin, and sectioning and dewaxing with xylene. It was then digested with trypsin, incubated with the TUNEL reaction solution at 37°C for 1 h, then incubated with peroxidase antibody at 37°C for 30 min; diamine benzidine (DAB) was added dropwise, the sample sections were incubated at room temperature for 30 min, then sealed and dried. The sample sections were then immersed in hematoxylin staining solution for nuclear staining for 5 min. The apoptosis rate was determined under a microscope by counting the cell nuclei stained with brownish‐yellow particles as apoptotic positive cells and the apoptosis rate (%) was calculated—apoptosis rate = (number of positive cells/total number of cells) × 100%. | PMC10291993 | ||
Statistical analysis | We used SPSS 25.0 software for the data analysis. Measurement data are expressed as mean values and the means of two samples were compared using the | PMC10291993 | ||
RESULTS | PMC10291993 | |||
Levels of Bcl‐2 and Bax in the two groups after surgery | The levels of Bcl‐2 gradually decreased and those of Bax gradually increased in both groups over time. On Day 21 post‐surgery, there were significant differences in the expression levels of Bcl‐2 and Bax between the groups (Expression Levels of Bcl‐2 and Bax in the postoperative tissues of the two groups.The expression of Bcl‐2 in Zibaigao group was compared with that in petroleum jelly on the 21st day after operation, | PMC10291993 | ||
TUNEL assay results on cell apoptosis in wound granulation tissue | On Day 14 post‐surgery, samples from the Zibai ointment group showed signs of apoptosis (brown‐yellow cells with nuclei) under light microscopy, including chromatin condensation (arrangement close to the karyotheca in a hemisphere‐shaped, crescent‐shaped or sickle‐shaped manner), cytoplasmic pyknosis, reduced cell volume, loose cell arrangement, irregular‐shaped cells, and occasional apoptotic bodies. The apoptotic cells in the petroleum jelly group decreased significantly at the same time point. We did not find any significant differences in the proportion of positive cells between the Zibai ointment and petroleum jelly control groups on Days 7 and 21 postsurgery (Apoptosis in each group detected by TUNEL assay (×200).Apoptosis index of in situ end‐labeling (The number of apoptotic positive cells in the Zibai ointment group on Day 7 after operation, compared with the Vaseline group, The number of apoptotic positive cells in the Zibai ointment group on Day 14 after operation, compared with the Vaseline group, The number of apoptotic positive cells in the Zibai ointment group on Day 21 after operation, compared with the Vaseline group, | PMC10291993 | ||
Comparison of postoperative healing time and clinical efficacy between the two groups | There was no significant difference in clinical efficacy between the two groups (Comparison of Postoperative Healing Time and Clinical Efficacy between the Two Groups. | PMC10291993 | ||
DISCUSSION | postoperative pain, fever, swelling, toxicity, edema, anorectal disorder, necrotic, pain, anorectal disorders, pruritus, fistula, dryness, sores | HEAT, EDEMA, ANORECTAL DISORDER, NECROTIC, ANORECTAL DISORDERS, PERIANAL ABSCESS, STASIS, DISEASES, COMPLICATIONS, INFLAMMATORY RESPONSE | Anal fistula is an anorectal disorder with high incidence, characterized by the formation of an abnormal tunnel between the rectum or anal canal and surrounding skin. Perianal abscess, pruritus, and pain are some of its clinical signs. Systemic inflammatory reactions, fever, and other symptoms may also be present in more severe cases. Due to the impossibility of self‐healing, surgical intervention is the therapeutic treatment of choice.Apoptotic processes are regulated by antiapoptotic (Bcl‐2) family proteins and Caspase family proteins by regulating the transduction of apoptotic signals, and their mutual checks and balances form a complete and efficient apoptosis mechanism network system.In the Bcl‐2 gene family, the apoptosis‐promoting gene Bax has been researched extensively due to its high degree of similarity with Bcl‐2. Bax has the ability to suppress Bcl‐2 by forming homodimers or heterodimers with Bcl‐2. Consequently, the antiapoptotic proteins Bcl‐2 and Bax are essential for regulating cell apoptosis.According to TCM, anorectal diseases are caused by stagnation of qi and blood and the downward flow of damp‐heat. Many TCM remedies aim to activate blood, remove stasis, alleviate pain, clear heat, dryness, and dampness, and reduce swelling. External therapies with these TCM remedies are widely used for the treatment of postoperative pain and edema complications in anorectal disorders due to their direct effect, minimal toxicity and side‐effects, safety, and convenience.Research has demonstrated the effectiveness of TCM in promoting wound healing, reducing pain, and suppressing the inflammatory response in patients after anal fistula surgery.Borneol, used as an adjuvant drug, clears heat, reduces swelling, relieves pain, and eliminates stagnation. According to TCM principles, the combination of these herbs in Zibai ointment helps to clear heat, dries out dampness, invigorates blood circulation, eliminates stasis, removes necrotic tissue, promotes granulation, heals sores, and fosters healing of wounds.The results of our study revealed statistically significant differences in the expression levels of Bcl‐2 and Bax between the Zibai ointment and petroleum jelly groups on Day 21 postsurgery (There is some preliminary evidence that Zibai ointment can promote wound healing following anal fistula surgery by controlling cell apoptosis. However, Zibai ointment induces an increase in the Bcl‐2/Bax ratio by regulating upstream factors of the Bcl‐2/Bax signaling pathway. Wound healing is aided by the ability of Zibai ointment to directly regulate the expression of Bcl‐2 and Bax, thereby promoting cell apoptosis during wound healing. All these issues need to be explored in greater detail. Using either multicenter studies or animal models, the study team can delve more deeply into the underlying mechanism of Zibai ointment in future investigations, providing a more objective basis for its clinical application.Study limitation: Due to uncertain factors such as the time limit of the study and patient compliance, the clinical sample size of this study is relatively small, but some significant differences have also been initially found. In subsequent studies, the research team can conduct multicenter studies or use animal models to deeply explore the internal mechanism of Zibai ointment, providing a more objective basis for its clinical application. | PMC10291993 |
AUTHOR CONTRIBUTIONS | PMC10291993 | |||
CONFLICT OF INTEREST STATEMENT | The authors declare no conflict of interest. | PMC10291993 | ||
ETHICS STATEMENT | The study was conducted in accordance with the Declaration of Helsinki(as was revised in 2013). The study was approved by Ethics Committee of the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine. Written informed consent was obtained from all participants (2020‐048‐02). | PMC10291993 | ||
ACKNOWLEDGMENTS | We are particularly grateful to all the people who have given us help on our article. Special project of the Chinese medicine clinical research base of the People's Hospital affiliated to the Fujian University of Traditional Chinese Medicine, project number: JDZX201938. | PMC10291993 | ||
REFERENCES | PMC10291993 | |||
1. Introduction | hedonic sensations, dyspepsia, functional gut disorders, satiety, fullness | These authors contributed equally to this work.Background. Meal ingestion induces a postprandial experience that involves homeostatic and hedonic sensations. Our aim was to determine the effect of aversive conditioning on the postprandial reward of a comfort meal. Methods: A sham-controlled, randomised, parallel, single-blind study was performed on 12 healthy women (6 per group). A comfort meal was tested before and after coupling the meal with an aversive sensation (conditioning intervention), induced by infusion of lipids via a thin naso-duodenal catheter; in the pre- and post-conditioning tests and in the control group, a sham infusion was performed. Participants were instructed that two recipes of a tasty humus would be tested; however, the same meal was administered with a colour additive in the conditioning and post-conditioning tests. Digestive well-being (primary outcome) was measured every 10 min before and 60 min after ingestion using graded scales. Results: In the aversive conditioning group, the comfort meal in the pre-conditioning test induced a pleasant postprandial experience, which was significantly lower in the post-conditioning test; the effect of aversive conditioning (change from pre- to post-conditioning) was significant as compared to sham conditioning in the control group, which showed no differences between study days. Conclusion: The hedonic postprandial response to a comfort meal in healthy women is impaired by aversive conditioning. ClinicalTrials.gov ID: NCT04938934.The digestive process that follows meal ingestion is associated with a postprandial experience that involves homeostatic sensations (satiety, fullness) with a hedonic dimension (digestive well-being, mood) [We hypothesised that the postprandial experience, in particular the hedonic component (i.e., postprandial sensation of digestive well-being), may be modified by conditioning. Our specific aim was to determine the effect of aversive conditioning on the hedonic and homeostatic sensations in response to a comfort meal in healthy subjects. The postprandial experience in humans is important because it may influence dietary decisions and habits. Moreover, a negative postprandial experience is a main complaint in patients with functional gut disorders, particularly in those with functional dyspepsia [ | PMC10221585 | |
2. Material and Methods | PMC10221585 | |||
2.1. Experimental Design | A sham-controlled, randomised, parallel, single-blind study on the effect of aversive conditioning on the responses to a comfort meal in healthy women was performed in a tertiary referral centre between February and August 2021. The research was conducted according to the Declaration of Helsinki. The protocol for the study had been previously approved by the Institutional Review Board of the University Hospital Vall d’Hebron (Comitè d’Ètica d’Investigació Clinica, Vall d’Hebron Institut de Recerca; protocol number PR(AG)338/2016M approved 28 October 2016, revised 11 December 2020) and all participants provided written informed consent. The study protocol was registered with | PMC10221585 | ||
2.2. Participants | gastrointestinal symptoms, non-obese | Twelve, non-obese, non-dieting and weight-stable women (6 per group), without history of gastrointestinal symptoms were recruited by public advertising to participate in the study. For this pilot, proof-of-concept study, only women were included for the sake of homogeneity and because some data indicate that they are more susceptible to factors that modulate the postprandial experience than men [ | PMC10221585 | |
2.3. Experimental Paradigm | Participants were informed that the aim of the study was to investigate the effect of meal composition on the postprandial responses and that a nasoduodenal tube was used to evaluate gastric outflow. Participants were informed that two recipes of a tasty humus with different compositions would be tested; however, the same meal (low-fat humus) without or with the addition of a colourant (i.e., non-coloured or coloured) was administered ( | PMC10221585 |
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