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Effects of 3 months of 10-h per-day time-restricted eating and 3 months of follow-up on bodyweight and cardiometabolic health in Danish individuals at high risk of type 2 diabetes: the RESET single-centre, parallel, superiority, open-label, randomised controlled trial.

Jens Juul Holst, Kristine Færch, Martin Bæk Blond, Graham Finlayson, Christina Brock, Satchidananda Panda, Marit Eika Jørgensen, Dorte Vistisen, Martin Erik Nyeland, Signe Sørensen Torekov, Jonas Salling Quist, Nicolai J Wewer Albrechtsen, Joachim Størling, Sarah Uldal, Trine Spragge Ekblond, Natasja Bjerre, Kim Katrine Bjerring Clemmensen, Marie Møller Jensen, Hanne Enghoff Pedersen

Journal: The lancet. Healthy longevity 2024;5(5):e314-e325

PMID: 38588687

Free Full Text on Elsevier Science View on PubMed

Plain Language Summary

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With the ever-increasing prevalence of overweight and obesity and the associated metabolic diseases, there is a strong need for simple and sustainable solutions to achieve and maintain healthy body weight. Evidence from several small studies has demonstrated that time-restricted eating, within a timeframe of 12 hours or less, leads to weight loss and improvements in blood sugar regulation, blood fats, and blood pressure. The RESET trial, an open-label, randomised controlled trial, investigated the effects of time-restricted eating (TRE) for 10 hours per day on body weight and cardiometabolic markers in Danish individuals at high risk of type 2 diabetes, over a period of 3 months. The study involved 100 participants (66 female and 34 male) aged 52–65, who were randomly assigned to the intervention or control group. At weeks 1, 6, 12 and 13 various measures were taken to monitor the impact, as well as a 6 month follow up. These included anthropometrics, blood glucose markers, blood pressure, blood lipids, and liver values. Participants also completed a self-assessed sleep and quality of life questionnaire. After 3 months the TRE did not lead to clinically relevant weight loss or improvement in cardiometabolic health. A small reduction in fat mass and HbA1c were observed in response to TRE when compared with the control group; however, these reductions were not statistically significant. Candidates who adhered to the TRE intervention experienced a mean weight loss of 1kg over the course of the trial, less than expected by the researchers, and it was also not maintained during the follow-up period. The intervention had a high retention rate of around 90%. The findings suggest that while TRE is a simple and feasible lifestyle change, it may not be effective for achieving significant weight loss in the short term for this population group. Future research should explore the long-term effects of TRE and its potential benefits for individuals with higher levels of body fat or metabolic dysfunction.

Expert Review

Reviewer: Jessica Rigutto
10th Jun 2024
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Conflict of interest

None

Take home message

  • This RCT found that TRE with no calorie deficit did not lead to a change in bodyweight nor in cardiometabolic markers in a middle-aged population living with overweight and obesity and with a high risk of T2D.
  • Further research on TRE with calorie deficit and in wider population groups is warranted.

Evidence category

A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)

Summary review

Introduction

  • This RCT assessed Time Restricted Eating (TRE) on bodyweight and cardiometabolic risk factors in individuals with overweight/obesity and risk of T2D.

Methods

  • Open-label RCT in 66 female and 34 male subjects, 30-70y, with overweight and prediabetes (HbA1c 39.47 mmol/mol), or obesity with or without prediabetes; with a habitual daily feeding window of >12h and >14h at least once weekly.
  • Subjects were equally assigned to intervention and control groups. Intervention subjects had to consume all foods and beverages except water within a 10h window between 6am and 10pm, for 3-months.
  • Primary outcome: change in body weight at 3-months and 3-months of subsequent free-living follow-up.
  • Secondary outcomes: changes in: body fat mass, fat-free mass, total energy intake, HbA1c, fasting plasma glucose, and fasting LDL cholesterol from baseline to 3-months and 3-months’ follow up.

Results

  • 46/50 intervention participants and 46/50 control participants completed the study.
  • Primary outcome: No difference in bodyweight between groups at 3-months (–0.8 kg, 95% CI –1.7 to 0.2; p=0.099) or at 3-months follow-up (-0.2 kg, 95% CI -1.6 to 1.2).
  • Secondary outcomes: At 3-months, fat mass (-1.0 kg: 95% CI -1.6 to -0.3; p=0.0067) and HbA1c (-1 mmol/mol; 95% CI -1 to 0; p=0.024) were lower in the intervention group, though lost significance when adjusted for multiplicity. No other secondary outcomes at either time point reached significance, including energy intake, which may explain the negative findings.

Conclusion

  • 3 months of TRE for 10h per day did not influence bodyweight or other associated cardiometabolic markers in individuals with overweight or obesity and risk of T2D.
  • This finding may be explained by the preservation of calorie intake in the intervention group despite the restriction in the feeding window.

Note: Several competing interests were declared for this study, however, are not believed by the author of this review to constitute a high risk of bias.

Clinical practice applications

  • TRE has gained visibility recently for its cellular health effects and has been popularised for its potential as a weight loss tool. This study found no effect of TRE on bodyweight or other cardiometabolic markers in middle-aged individuals with overweight or obesity and at high risk of T2D.
  • Clinical practitioners may choose to advise clients to follow a TRE pattern for its other benefits, however, should consider carefully managing client expectations on the effects of TRE on weight loss, particularly if there is no calorie deficit achieved through TRE practice.

Considerations for future research

  • Future research could investigate a calorie deficit in conjunction with TRE.
  • This intervention was highly accepted, and therefore longer term interventions could also be considered.
  • The participants of this study were mainly white Caucasian; studies in a wider demographic are justified.
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Expert reviews are written by nutrition professionals and academics with advanced qualifications to provide a critical appraisal of the article and implications for practice. Each review is peer-reviewed by a member of the NED Editorial Board. Find out more about our NED Expert Reviewers here.

Abstract

BACKGROUND

Time-restricted eating (TRE) has been suggested to be a simple, feasible, and effective dietary strategy for individuals with overweight or obesity. We aimed to investigate the effects of 3 months of 10-h per-day TRE and 3 months of follow-up on bodyweight and cardiometabolic risk factors in individuals at high risk of type 2 diabetes.

METHODS

This was a single-centre, parallel, superiority, open-label randomised controlled clinical trial conducted at Steno Diabetes Center Copenhagen (Denmark). The inclusion criteria were age 30-70 years with either overweight (ie, BMI ≥25 kg/m) and concomitant prediabetes (ie, glycated haemoglobin [HbA] 39-47 mmol/mol) or obesity (ie, BMI ≥30 kg/m) with or without prediabetes and a habitual self-reported eating window (eating and drinking [except for water]) of 12 h per day or more every day and of 14 h per day or more at least 1 day per week. Individuals were randomly assigned 1:1 to 3 months of habitual living (hereafter referred to as the control group) or TRE, which was a self-selected 10-h per-day eating window placed between 0600 h and 2000 h. Randomisation was done in blocks varying in size and was open for participants and research staff, but outcome assessors were masked during statistical analyses. The randomisation list was generated by an external statistician. The primary outcome was change in bodyweight, assessed after 3 months (12 weeks) of the intervention and after 3 months (13 weeks) of follow-up. Adverse events were reported and registered at study visits or if participants contacted study staff to report events between visits. This trial is registered on ClinicalTrials.gov (NCT03854656).

FINDINGS

Between March 12, 2019, and March 2, 2022, 100 participants (66 [66%] were female and 34 [34%] were male; median age 59 years [IQR 52-65]) were enrolled and randomly assigned (50 to each group). Of those 100, 46 (92%) in the TRE group and 46 (92%) in the control group completed the intervention period. After 3 months of the intervention, there was no difference in bodyweight between the TRE group and the control group (-0·8 kg, 95% CI -1·7 to 0·2; p=0·099). Being in the TRE group was not associated with a lower bodyweight compared with the control group after subsequent 3-month follow-up (-0·2 kg, -1·6 to 1·2). In the per-protocol analysis, participants who completed the intervention in the TRE group lost 1·0 kg (-1·9 to -0·0; p=0·040) bodyweight compared with the control group after 3 months of intervention, which was not maintained after the 3-month follow-up period (-0·4 kg, -1·8 to 1·0). During the trial and follow-up period, one participant in the TRE group reported a severe adverse event: development of a subcutaneous nodule and pain when the arm was in use. This side-effect was evaluated to be related to the trial procedures.

INTERPRETATION

3 months of 10-h per-day TRE did not lead to clinically relevant effects on bodyweight in middle-aged to older individuals at high risk of type 2 diabetes.

FUNDING

Novo Nordisk Foundation, Aalborg University, Helsefonden, and Innovation Fund Denmark.

Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Address: Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark; School of Psychology, University of Leeds, Leeds, UK. Electronic address: [email protected].; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark; iMotions, Copenhagen, Denmark; Novo Nordisk, Søborg, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; Novo Nordisk, Søborg, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; Department of Food and Resource Economics, University of Copenhagen, Copenhagen, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Biochemistry, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; Department of Public Health, University of Copenhagen, Copenhagen, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark; Steno Diabetes Center Greenland, Nuuk, Greenland.; Salk Institute for Biological Studies, San Diego, CA, USA.; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; Steno Diabetes Center Northern Jutland, Aalborg, Denmark.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; School of Psychology, University of Leeds, Leeds, UK.; Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Herlev, Denmark; Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk, Søborg, Denmark.
DOI: 10.1016/S2666-7568(24)00028-X

Patient Centred Factor

Mediators: Time restricted eating

Clinical Imbalances

Immune and inflammation Gastro-intestinal

Laboratory Testing

Blood

Modifiable Lifestyle Factors

Diet

Nutrition Evidence Keywords

Obesity Overweight HbA1c Metabolic disease Fasting Blood glucose Cardiometabolic Intermittent fasting Prediabetic Blood lipids Diabetes type 2 Time restricted eating

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MeSH Terms: Humans, Diabetes Mellitus, Type 2, Middle Aged, Female, Male, Denmark, Aged, Follow-Up Studies, Body Weight, Adult, Overweight, Obesity
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