Cambridge University Hospitals NHS Foundation Trust
Maria Chondronikola
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.
Obesity
PreDiabetes
Time restricted eating
Extended eating window
Healthy diet
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 100 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | The Effect of Time-Restricted Eating in Cardiometabolic Health |
Actual Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | June 30, 2028 |
Estimated Study Completion Date : | August 31, 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: TRE group 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: Time restricted eating Behavioral: Healthy diet |
Active Comparator: Control group 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: Extended eating window Behavioral: Healthy diet |
Ages Eligible for Study: | 25 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Cambridge Clinical Research Center
Cambridge, United Kingdom, CB2 0QQ