NCT05866406

The Effect of Time-Restricted Eating in Cardiometabolic Health

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	Time restricted eating	Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
BEHAVIORAL	Extended eating window	Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
BEHAVIORAL	Healthy diet	Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.

Timeline

• Start date: 2023-11-01
• Primary completion: 2028-06-30
• Completion: 2028-08-31
• First posted: 2023-05-19
• Last updated: 2025-11-24

Locations

1 site across 1 country: United Kingdom