Clinical Trial

The Effect of Time-Restricted Eating in Cardiometabolic Health

Study acronym: TRE
Recruiting
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Summary
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-05-10; most recent amendment 2026-05-27.
Status change: Not Yet Recruiting → Recruiting 2023-08-31
Trial Details
NCT Number NCT05866406
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Conditions Obesity, PreDiabetes
Enrollment 100 participants
Start Date 2023-11-01
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-28