Dataset Information

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial.

ABSTRACT:

Background

Time restricted eating (TRE) is an emerging dietary intervention for weight loss that is hypothesized to reinforce the metabolic benefits of nightly fasting/ketosis. This pilot study investigated the effectiveness of a daily 14-h metabolic fast (14:10 TRE beginning after dinner, a "fasting snack" at hour 12, and ending with breakfast 14 h later) combined with a commercial weight management program on body weight and fasting blood glucose (FBG) in individuals with obesity. We also investigated the effect of the low-calorie, high-fat, low-carbohydrate, and low-protein "fasting snack" on blood glucose.

Methods

This 8-week, randomized, controlled, clinical trial included men and women (BMI ≥ 30 kg/m²) between June and October 2020. Study procedures were conducted remotely. Participants were randomized to 14:10 or 12-h TRE (12:12, active comparator) and prescribed a diet (controlled for calories and macronutrient composition) and exercise program that included weekly customized counseling and support. The primary outcome was change from baseline in body weight in the 14:10 group.

Results

Of the 78 randomized participants, 60 (n = 30/group) completed 8 weeks. The LS mean change from baseline in weight in the 14:10 group was -8.5% (95% CI -9.6 to -7.4; P < 0.001) and -7.1% (-8.3 to -5.8; P < 0.001) in the 12:12 group (between group difference -1.4%; -2.7 to -0.2; P < 0.05). There was a statistically significant LS mean change from baseline to week 8 in FBG in the 14:10 group of -7.6 mg/dl (95% CI -15.1 to -0.1; P < 0.05) but not in the 12:12 group (-3.1 mg/dl, -10.0 to 3.7; P = NS). Both interventions resulted in a larger reduction in FBG in participants with elevated FBG (≥100 mg/dl) at baseline (both P < 0.05).

Conclusions

In participants with obesity who completed 8 weeks of the 14:10 TRE schedule combined with a commercial weight loss program, there was statistically significant and clinically meaningful weight loss and improvements in FBG.

SUBMITTER: Peeke PM

PROVIDER: S-EPMC7809455 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial.

Peeke Pamela M PM Greenway Frank L FL Billes Sonja K SK Zhang Dachuan D Fujioka Ken K

Nutrition & diabetes 20210115 1

<h4>Background</h4>Time restricted eating (TRE) is an emerging dietary intervention for weight loss that is hypothesized to reinforce the metabolic benefits of nightly fasting/ketosis. This pilot study investigated the effectiveness of a daily 14-h metabolic fast (14:10 TRE beginning after dinner, a "fasting snack" at hour 12, and ending with breakfast 14 h later) combined with a commercial weight management program on body weight and fasting blood glucose (FBG) in individuals with obesity. We a ...[more]

PMID: 33446635

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Project description:IntroductionImpaired fasting glucose (IFG) is a significant risk factor for diabetes mellitus. Time-restricted eating (TRE) is one type of diet showing positive effects on metabolic signal pathways. However, effects of TRE on cardiometabolic risk factors in humans are limited. Additionally, compliance with TRE remains problematic despite having intention to follow the diet control. Therefore, this study aims to investigate the efficacy of TRE with behavioural economic interventions or TRE alone relative to usual care, in reducing fasting plasma glucose (FPG), haemoglobin A1c (HbA1c) and other cardiometabolic risk factors in patients with IFG.Methods and analysisThis parallel-group, open-label randomised controlled trial will be conducted at the outpatient clinic of the Department of Family Medicine, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand. Patients aged 18-65 years with IFG defined as FPG 100-125 mg/dL and body mass index ≥25 kg/m2 will be recruited between October 2021 and October 2022. Patients will be randomly allocated to three groups (1:1:1 ratio) as (1) TRE with behavioural economic interventions including financial incentives and text reminders, (2) TRE alone or (3) usual care. The number of participants will be 38 per group (a total of 114). The duration of the intervention will be 12 weeks. Primary outcome is FPG levels measured at 12 weeks after randomisation. Secondary outcomes are HbA1c, body weight, systolic and diastolic blood pressure, fasting insulin, serum triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and high-sensitivity C reactive protein. P value of <0.05 of two-sided test will be considered as statistical significance.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of the Faculty of Medicine, Ramathibodi Hospital, Mahidol University (MURA2021/389). All patients will be informed about the details of the study and sign written informed consent before enrollment in the study. Results from this study will be published in a peer-reviewed journal.Trial registration numberTCTR20210520002.

Project description:BackgroundRandomized controlled trials of time restricted eating (TRE) in adults have demonstrated improvements in glucose variability as captured by continuous glucose monitors (CGM). However, little is known about the feasibility of CGM use in TRE interventions in adolescents, or the expected changes in glycemic profiles in response to changes in meal-timing. As part of a pilot trial of TRE in adolescents with obesity, this study aimed to 1) assess the feasibility of CGM use, 2) describe baseline glycemic profiles in adolescents with obesity, without diabetes, and 3) compare the difference between glycemic profiles in groups practicing TRE versus control.MethodsThis study leverages data from a 12-week pilot trial (ClinicalTrials.gov Identifier: NCT03954223) of late TRE in adolescents with obesity compared to a prolonged eating window. Feasibility of CGM use was assessed by monitoring 1) the percent wear time of the CGM and 2) responses to satisfaction questionnaires. A computation of summary measures of all glycemic data prior to randomization was done using EasyGV and R. Repeat measures analysis was conducted to assess the change in glycemic variability over time between groups. Review of CGM tracings during periods of 24-hour dietary recall was utilized to describe glycemic excursions.ResultsFifty participants were enrolled in the study and 43 had CGM and dietary recall data available (16.4 + 1.3 years, 64% female, 64% Hispanic, 74% public insurance). There was high adherence to daily CGM wear (96.4%) without negative impacts on daily functioning. There was no significant change in the glycemic variability as measured by standard deviation, mean amplitude glycemic excursion, and glucose area under the curve over the study period between groups.ConclusionsCGM use appears to be a feasible and acceptable tool to monitor glycemic profiles in adolescents with obesity and may be a helpful strategy to confirm TRE dosage by capturing glycemic excursions compared to self-reported meal timing. There was no effect of TRE on glucose profiles in this study. Further research is needed to investigate how TRE impacts glycemic variability in this age group and to explore if timing of eating window effects these findings.

Project description:BackgroundTime-restricted eating (TRE) is a dietary regimen that limits food intake for at least 12 h daily. Unlike other fasting protocols, TRE does not dictate what or how much to eat but rather focuses on the timing of meals. This approach has been previously demonstrated to improve body composition in individuals with obesity or metabolic impairments. However, its impact on body composition and cardiometabolic factors in healthy individuals remains unclear. Furthermore, the optimal fasting duration is still debated. Thus, we aimed to compare the effects of 8 weeks of different fasting durations on body composition and biochemical parameters in metabolically healthy, non-trained individuals using a parallel randomized controlled trial.MethodsForty-one volunteers were randomly assigned to one of the four experimental groups: TRE 16:8 (16 h of fasting,8 h of eating), TRE 14:10 (14 h of fasting,10 h of eating), TRE 12:12 (12 h of fasting,12 h of eating) or a normal diet group (ND; no dietary restriction). Participants underwent body composition measurements and blood tests for lipid profiles (i.e., total cholesterol, LDL, HDL, and triglycerides), fasting glucose, leptin, and anabolic hormones (i.e., insulin and testosterone) levels. Data were analyzed using both intention-to-treat (ITT) and per-protocol (PP) analysis to account for compliance. A two-way ANOVA for repeated measures was employed to assess interactions between time and group.ResultsIn the ITT analysis, TRE 16:8 reduced body mass (-2.46%, p = 0.003) and absolute fat mass (-8.65%, p = 0.001) with no changes in lean soft tissue and in calorie intake. These results were consistent with the PP analysis which included 8 participants in TRE 16:8, 5 in TRE 14:10, 9 in TRE 12:12, and the entire ND group. Participants in the TRE 16:8 group spontaneously reduced their total caloric intake, although this reduction was not statistically significant. None of the other measurements significantly changed after 8 weeks.ConclusionsOur results suggest that a 16-hour fasting window, even without caloric restriction, may be a viable strategy for improving body composition in healthy and non-trained individuals, whereas a shorter fasting period may be insufficient to produce significant changes in a healthy population.Trial registrationNCT, NCT04503005. Registered 4 August 2020, https://clinicaltrials.gov/study/NCT04503005 .

Dataset Information

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial.

Background

Methods

Results

Conclusions

Publications

Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial.

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