Status:
TERMINATED
The Effect of Time-Restricted Eating in Cardiometabolic Health
Lead Sponsor:
University of California, Davis
Conditions:
Obesity
Pre-diabetes
Eligibility:
All Genders
21-70 years
Phase:
NA
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 withou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04484987
Start Date
November 20 2020
End Date
May 20 2024
Last Update
August 22 2024
Active Locations (1)
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1
University of California, Davis
Davis, California, United States, 95616-5398