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Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study.

ABSTRACT: The efficacy of time-restricted eating for weight loss has not been established, as prior studies were limited by a lack of controlled isocaloric designs. This study describes the design and implementation of interventions in a controlled eating study evaluating time-restricted eating. We designed a randomized, controlled, parallel-arm eating study comparing time-restricted eating (TRE) to a usual eating pattern (UEP) for the primary outcome of weight change. Participants were aged 21-69 years with prediabetes and obesity. TRE consumed 80% of calories by 1300 h (military time), and UEP consumed ≥ 50% of calories after 1700 h (military time). Both arms consumed identical macro- and micro-nutrients based on a healthy, palatable diet. We calculated individual calorie requirements, which were maintained throughout the intervention. The desired distribution of calories across eating windows in both arms was achieved, as were the weekly averages for macronutrients and micronutrients. We actively monitored participants and adapted diets to facilitate adherence. We provide the first report, to our knowledge, on the design and implementation of eating study interventions that isolated the effect of meal timing on weight while maintaining constant caloric intake and identical diets during the study period.

SUBMITTER: White K

PROVIDER: S-EPMC10144293 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study.

White Karen K Wu Beiwen B Pilla Scott J SJ Charleston Jeanne J Maw May Thu Thu MTT Appel Lawrence J LJ Clark Jeanne M JM Maruthur Nisa M NM

Nutrients 20230420 8

The efficacy of time-restricted eating for weight loss has not been established, as prior studies were limited by a lack of controlled isocaloric designs. This study describes the design and implementation of interventions in a controlled eating study evaluating time-restricted eating. We designed a randomized, controlled, parallel-arm eating study comparing time-restricted eating (TRE) to a usual eating pattern (UEP) for the primary outcome of weight change. Participants were aged 21-69 years w ...[more]

PMID: 37111198

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Project description:BackgroundObesity is a major health problem with a significant impact on quality of life and is a major risk factor for other diseases such as diabetes. There is a growing body of evidence that time-restricted eating (TRE) as one form of intermittent fasting (IF) represents a promising weight management strategy. Given the lack of evidence-based weight management strategies in the primary health care setting, the aim of this study is to investigate the effect of TRE in general practice in Germany.MethodsINDUCT is a type hybrid I, randomized-controlled study conducted in 41 practices within the newly established general practice-based research network (GPBRN) in Baden-Wuerttemberg (FoPraNet-BW). The study population consists of patients with a Body Mass Index between 30-45 kg (kg)/m2. The intervention group receives TRE at the scheme 16:8 (16 h fasting; 8 h energy intake) while the control group receives care as usual. The primary outcome is change in body weight under a 6-month period of TRE. Secondary outcomes are related to the patient (e.g. quality of life) and the practice (e.g. knowledge about research in own practice). As the INDUCT study represents one of the first four use-cases within the Research Network Baden-Wuerttemberg (FoPraNet-BW), feasibility is a further secondary outcome. The target sample size is 208 patients with a 1:1 randomization. An intention-to-treat approach is used for data analysis.DiscussionINDUCT adds evidence on the effect of TRE as a weight management strategy in general practice. Relevant factors for a sustainable and successful implementation in general practice will be revealed and can be applied for future implementation of TRE interventions in general practice if proven successful. In addition, important lessons learned regarding the conduction of clinical research within FoPraNet-BW will be derived. This fosters a sustainable implementation of a research infrastructure in general practice in Germany. DRKS-ID (German Clinical Trials Register-ID): DRKS00031928 (Date of registration in DRKS: 2023-06-22; Link: https://drks.de/search/de/trial/DRKS00031928 ).

Project description:BackgroundAlthough there is substantial interest in intermittent fasting as a dietary approach in active individuals, information regarding its effects in elite endurance athletes is currently unavailable. The present parallel randomized trial investigated the effects of a particular intermittent fasting approach, called time-restricted eating (TRE), during 4 weeks of high-level endurance training.MethodsSixteen elite under-23 cyclists were randomly assigned either to a TRE group or a control group (ND). The TRE group consumed 100% of its estimated daily energy needs in an 8-h time window (from 10:00 a.m. to 6:00 p.m.) whilst energy intake in the ND group was distributed in 3 meals consumed between 7:00 a.m. and 9:00 p.m. Fat and fat-free mass were estimated by bioelectrical impedance analysis and VO2max and basal metabolism by indirect gas analyzer. In addition, blood counts, anabolic hormones (i.e. free testosterone, IGF-1) and inflammatory markers (i.e. IL-6, TNF-α) were assessed.ResultsTRE reduced body weight (- 2%; p = 0.04) and fat mass percentage (- 1.1%; p = 0.01) with no change in fat-free mass. Performance tests showed no significant differences between groups, however the peak power output/body weight ratio (PPO/BW) improved in TRE group due to weight loss (p = 0.02). Free testosterone and IGF-1 decreased significantly (p = 0.01 and p = 0.03 respectively) in TRE group. Leucocyte count decreased in ND group (p = 0.02) whilst the neutrophils-to-lymphocytes ratio (NLR) decreased significantly (p = 0.03) in TRE group.ConclusionsOur results suggest that a TRE program with an 8-h feeding window elicits weight loss, improves body composition and increases PPO/BW in elite cyclists. TRE could also be beneficial for reducing inflammation and may have a protective effect on some components of the immune system. Overall, TRE could be considered as a component of a periodized nutrition plan in endurance athletes.Trial registrationThis trial was retrospectively registered at clinicaltrials.gov as NCT04320784 on 25 March 2020.

Project description:Background Time restricted eating (TRE), limiting eating to a specific daily window, is a novel dietary intervention, but the mechanisms by which TRE results in weight loss remain unclear. The goal of the current study was to examine changes in eating patterns, sleep, and late-night eating, and associations with health outcomes in a secondary analysis of a 12-week self-selected TRE intervention. Methods Twenty participants 18–65 years with BMI ≥25 kg/m2 completed the 12-week trial. Participants randomized to TRE (n = 11) were instructed to eat during a self-selected 8-h window, while the non-TRE group (n = 9) followed their typical eating habits. All participants logged oral intake using the myCircadian Clock mobile application throughout the entire intervention. Anthropometrics, HbA1c, an oral glucose tolerance test, and 2 weeks of actigraphy monitoring were completed at pre-intervention and end-intervention. Independent samples t-tests compared differences between groups. Data are presented as mean ± standard deviation. Results At preintervention, late night eating was significantly associated with higher fasting glucose (r = 0.59, p = 0.006) and higher HbA1c (r = 0.46, p = 0.016). The TRE group significantly delayed the timing of the first eating occasion by 2.72 ± 1.48 h relative to wake time (p < 0.001) and advanced the timing of the last eating occasion by 1.25 ± 0.8 h relative to bedtime (p < 0.001). The non-TRE group, on average, maintained their eating pattern. Sleep measures did not change from pre- to end-intervention, however greater restriction of the eating window was associated with longer sleep duration at end-intervention (β = −0.46 [95% CI −9.2, −0.4], p = 0.03). The TRE group significantly reduced the prevalence of late night eating (eating within 2 h of bedtime) by 14 ± 6% (p = 0.028) with 63% of participants completely eliminating late night eating at end-intervention. Conclusion A self-selected TRE intervention significantly shifted meal timing, reduced late-night eating while prolonging sleep duration. Trial registry ClinicalTrials.gov, identifier: 03129581.

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Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study.

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Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study.

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