The Effect of Time-Restricted Eating in Cardiometabolic Health

  • STATUS
    Recruiting
  • End date
    Sep 5, 2025
  • participants needed
    100
  • sponsor
    University of California, Davis
Updated on 19 February 2024
body mass index
insulin
glycosylated hemoglobin
hba1c
plasma glucose
cardiovascular disease
fasting
insulin sensitivity
hemoglobin a1c
manipulation
glucose intolerance
caloric restriction

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.

Details
Condition Prediabetes, Obesity, Obesity
Age 25-70 years
Treatment 9 hours daily eating window, 15 hours daily eating window
Clinical Study IdentifierNCT04484987
SponsorUniversity of California, Davis
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

body mass index 27-40 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
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
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