The Effect of Time-Restricted Eating in Cardiometabolic Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Insulin sensitivity
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Maria Chondronikola
Principal Investigator
Cambridge University Hospitals NHS Foundation Trust
Eligibility Criteria
Inclusion Criteria
- •must be able to grant voluntary informed consent and comply with the study instructions
- •aged 25-75 years
- •men and women
- •body mass index 27-45 kg/m2
- •fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73
- •self-reported habitual eating period ≥ 13 h per day
Exclusion Criteria
- •shift worker
- •fasting \>12 h/day more than once a week
- •\> once a week no food intake after \~1800 h
- •habitually waking up before \~0400 h and sleeping before \~2100 h
- •unstable weight (\>5% change the last 2 months)
- •Clinical diagnosis of type 1 or 2 diabetes
- •Clinical diagnosis of sleep disorder
- •Clinical diagnosis of eating disorder
- •Clinical diagnosis of cancer in last 5 years
- •conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study)
Outcomes
Primary Outcomes
Insulin sensitivity
Time Frame: 3 months (pre-post intervention)
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
Secondary Outcomes
- 24 h glycemic control(3 months (pre-post intervention))
- Adipose tissue gene expression(3 months (pre-post intervention))