Clinical trial NCT04484987: The Effect of Time-Restricted Eating in Cardiometabolic Health
Official title: The Effect of Time-Restricted Eating in Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Pre-diabetes
Keywords: Chrono-nutrition
Adipose tissue
Skeletal muscle
Insulin sensitivity
Diurnal rhythm
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.
Primary purpose: PREVENTION

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.


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
* cancer in last 5 years
* conditions that render subject unable to complete all testing procedures
* use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.)
* smoking and illegal drug use
* pregnant or lactating
* menopause
* individuals that have performed procedures involving substantial exposure to radiation in the last 12 months
* gastrointestinal or bariatric surgery
* unable to grant voluntary informed consent or comply with the study instructions
* individuals who are not yet adults (infants, children, teenagers)
* prisoners

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 3 months (pre-post intervention)
measure: 24 h glycemic control
timeFrame: 3 months (pre-post intervention)
measure: Adipose tissue gene expression
timeFrame: 3 months (pre-post intervention)
Secondary outcomes:
measure: Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells
timeFrame: 3 months (pre-post intervention)
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
References: