The Effect of Time-Restricted Eating in Cardiometabolic Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of California, Davis
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Adipose tissue gene expression
- Status
- Terminated
- Last Updated
- last year
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
Eligibility Criteria
Inclusion Criteria
- •body mass index 30-39.9 kg/m2
- •fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4%
- •self-reported habitual eating period \> 15 h per day
Exclusion Criteria
- •shift worker, recent or expected travel crossing time zones
- •fasting \>12 h/day more than once a week or vegan
- •shift worker, recent or expected travel crossing time zones
- •fasting \>12 h/day more than once a week or vegan
- •\> once a week no food intake after 1800 h
- •habitually waking up before 0400 h and sleeping before 2230 h
- •≥ 150 min per week of structured exercise
- •unstable weight (\>5% change the last 2 months)
- •type 2 diabetes or other major chronic disease
- •sleep disorder
Outcomes
Primary Outcomes
Adipose tissue gene expression
Time Frame: 3 months (pre-post intervention)
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.
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.
24 h glycemic control
Time Frame: 3 months (pre-post intervention)
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Secondary Outcomes
- Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells(3 months (pre-post intervention))