NCT03393195: TREAT

Study of Time-restricted Eating on Weight Loss.

Completed NA Last updated 3 March 2020

What this trial tests

NA trial testing Time-restricted Eating plan in Obesity in 137 participants. Completed in 10 January 2020.

Timeline

30 July 2018

Primary endpoint
23 October 2019

10 January 2020

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	137
Start date	30 July 2018
Primary completion	23 October 2019
Estimated completion	10 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Time-restricted Eating plan
• Consistent Meal timing plan

Conditions studied

• Obesity — all drugs for Obesity →
• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 64, any sex, with Obesity or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized controlled trial studying the effects of time-restricted eating (TRE) on weight loss in obese humans. Obesity is the number one risk factor for type 2 Diabetes Mellitus (T2DM), and numerous studies demonstrate that weight loss is an effective strategy to prevent T2DM and improve the metabolic health of people diagnosed with T2DM. Unfortunately, classical calorie restriction diets often fail to produce long-term weight loss due to low compliance, reduced resting metabolic rate (RMR), and other factors. Therefore, novel dieting techniques must be explored in order to successfully treat obesity and prevent T2DM. Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and metabolic health markers in the absence of calorie restriction. Limited research in human subjects suggests that this feeding paradigm may translate to human health as well, however, more research needs to be done in order to confirm this hypothesis. This study will determine if TRE can lead to weight loss in obese human subjects. Secondary outcomes include changes in body composition, HOMA-IR, hormonal and biochemical serum markers, RMR, and total energy expenditure (TEE).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial.
   Lowe DA, Wu N, Rohdin-Bibby L, Moore AH, et al · · 2020 · cited 375× · PMID 32986097 · DOI 10.1001/jamainternmed.2020.4153
2. Effects of Intermittent Fasting in Human Compared to a Non-intervention Diet and Caloric Restriction: A Meta-Analysis of Randomized Controlled Trials.
   Gu L, Fu R, Hong J, Ni H, et al · · 2022 · cited 38× · PMID 35586738 · DOI 10.3389/fnut.2022.871682
3. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry.
   Wong MC, Bennett JP, Leong LT, Tian IY, et al · · 2023 · cited 19× · PMID 36796647 · DOI 10.1016/j.ajcnut.2023.02.006
4. Intermittent Fasting: Myths, Fakes and Truth on This Dietary Regimen Approach.
   Brogi S, Tabanelli R, Puca S, Calderone V. · · 2024 · cited 11× · PMID 38998465 · DOI 10.3390/foods13131960
5. Comparing caloric restriction regimens for effective weight management in adults: a systematic review and network meta-analysis.
   Huang J, Li Y, Chen M, Cai Z, et al · · 2024 · cited 6× · PMID 39327619 · DOI 10.1186/s12966-024-01657-9