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The Effect of Time-Restricted Eating in Cardiometabolic Health

Study acronym: TRE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Nov 19, 2025, no change to tracked fieldsv5-v6
  2. Start date changed from estimate of Sep 1, 2023 to Nov 1, 2023v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 1, 2023 to Sep 1, 2023
    • Study sites: 0 to 1
    v3
  4. Interventions: Control (Behavioral), Healthy diet (Behavioral), Time restricted eating (Behavioral) to Extended eating window (Behavioral), Healthy diet (Behavioral), Time restricted eating (Behavioral)
    • Secondary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 5 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05866406
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Conditions
(from sponsor)		 Obesity, PreDiabetes
Related terms Obesity, Prediabetic State
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov