Summary

Eligibility
for people ages 21-70 (full criteria)
Location
at Davis, California
Dates
study started
estimated completion
Principal Investigator
by Maria Chondronikola

Description

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.

Official Title

The Effect of Time-Restricted Eating in Cardiometabolic Health

Keywords

Obesity Pre-diabetes Chrono-nutrition Adipose tissue Skeletal muscle Insulin sensitivity Diurnal rhythm Prediabetic State 9 hours daily eating window 15 hours daily eating window

Eligibility

You can join if…

Open to people ages 21-70

  • 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

You CAN'T join if...

  • 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

Location

  • University of California, Davis accepting new patients
    Davis California 95616-5398 United States

Lead Scientist at UC Davis

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT04484987
Study Type
Interventional
Last Updated