Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial
Pavlou V, Cienfuegos S, Lin S, Ezpeleta M, Ready K, Corapi S, Wu J, Lopez J, Gabel K, Tussing-Humphreys L, Oddo VM, Alexandria SJ, Sanchez J, Unterman T, Chow LS, Vidmar AP, Varady KA
JAMA network open · 104 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- National Institutes of Health
- Government
- National Institute of Diabetes and Digestive and Kidney Diseases
- Government
- NIDDK NIH HHS
- Grants
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK020595); National Institute of Diabetes and Digestive and Kidney Diseases (R01DK128180); National Institute of Diabetes and Digestive and Kidney Diseases (T32 DK128782)
Based on 3 listed funder(s).
Publication
- Published
- 2023-10-27 · JAMA Netw Open · vol. 6 · issue 10 · p. e2339337
- Publisher
- American Medical Association
- Cited
- 161 citations · more than 100% of similar papers · 22.1× the field average
- Impact
- Top 10% most cited in its field
- References
- 27 works
- Access
- Open access (journal) · CC-BY-NC-ND
- Research areas
- Dietary Effects on Health · Enhanced Recovery After Surgery · Circadian rhythm and melatonin
- Keywords
- Medicine, Glycemic, Body mass index, Weight loss, Type 2 diabetes, Randomized controlled trial, Weight change, Obesity, Calorie, Diabetes mellitus, Physical therapy, Internal medicine, Gerontology, Endocrinology
- MeSH
- humans, diabetes mellitus, type 2, obesity, weight loss, risk factors, adult, aged, middle aged, female, male, glycated hemoglobin
17 authors
From US
- Vasiliki PavlouUniversity of Illinois Chicago
- Sofia CienfuegosUniversity of Illinois Chicago
- Shuhao LinUniversity of Illinois Chicago
- Mark EzpeletaUniversity of Illinois Chicago
- Kathleen A. ReadyUniversity of Illinois Chicago
- Sarah CorapiUniversity of Illinois Chicago
Abstract
Importance
Time-restricted eating (TRE) has become increasingly popular, yet longer-term randomized clinical trials have not evaluated its efficacy and safety in patients with type 2 diabetes (T2D).
Objective
To determine whether TRE is more effective for weight reduction and glycemic control than daily calorie restriction (CR) or a control condition in adults with T2D.
Design, setting, and participants
This 6-month, parallel-group, randomized clinical trial was performed between January 25, 2022, and April 1, 2023, at the University of Illinois Chicago. Participants were aged 18 to 80 years with obesity and T2D. Data analysis was based on intention to treat.
Interventions
Participants were randomized to 1 of 3 groups: 8-hour TRE (eating 12 to 8 pm only, without calorie counting), CR (25% energy restriction daily), or control.
Main outcomes and measures
The primary outcome measure was change in body weight by month 6. Secondary outcomes included changes in hemoglobin A1c (HbA1c) levels and metabolic risk factors.
Results
Seventy-five participants were enrolled with a mean (SD) age of 55 (12) years. The mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 39 (7) and the mean (SD) HbA1c level was 8.1% (1.6%). A total of 53 participants (71%) were women. One participant (1%) was Asian, 30 (40%) were Hispanic White, 40 (53%) were non-Hispanic Black, and 4 (5%) were non-Hispanic White. Participants in the TRE group were adherent with their eating window on a mean (SD) of 6.1 (0.8) days per week, and 17 (68%) in the CR group were adherent with their prescribed calorie goals over 6 months. The mean (SD) reduction in energy intake was -313 (509) kcal/d for TRE, -197 (426) kcal/d for CR, and -16 (439) kcal/d for controls. By month 6, body weight decreased significantly in the TRE group (-3.56% [95% CI, -5.92% to -1.20%]; P = .004) but not the CR group (-1.78% [95% CI, -3.67% to 0.11%]; P = .06), relative to controls. Levels of HbA1c decreased in the TRE (-0.91% [95% CI, -1.61% to -0.20%]) and CR (-0.94% [95% CI, -1.59% to -0.30%]) groups, relative to controls, with no differences between the TRE and CR groups. Time in euglycemic range, medication effect score, blood pressure, and plasma lipid levels did not differ among groups. No serious adverse events were reported.
Conclusions and relevance
This randomized clinical trial found that a TRE diet strategy without calorie counting was effective for weight loss and lowering of HbA1c levels compared with daily calorie counting in a sample of adults with T2D. These findings will need to be confirmed by larger RCTs with longer follow-up.
Trial registration
ClinicalTrials.gov Identifier: NCT05225337.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
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