The Effect of Time-Restricted Eating in Cardiometabolic Health
Key facts
- Who runs it
- University of California, Davis
- Where
- Davis, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 55 people enrolled
- Started
- 20 Nov 2020
- Ended
- 20 May 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- 9 hours daily eating window
- 15 hours daily eating window
- Record updated
- 22 August 2024
- Why it stopped
- Funding withdrawn as the principal investigator moved from the USA to the UK
Who can take part
- Age
- 21 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- individuals that have performed procedures involving substantial exposure to radiation in the last 12 months
- gastrointestinal or bariatric surgery
- 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
- 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)
- pregnant or lactating
- menopause
- unable to grant voluntary informed consent or comply with the study instructions
- individuals who are not yet adults (infants, children, teenagers)
- prisoners
Where in United States
- University of California, DavisDavis, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- TRE groupOther group
Time-restricted eating group
Treatment: 9 hours daily eating window
- Control groupOther group
Time-unrestricted eating group
Treatment: 15 hours daily eating window
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 22 August 2024