The Effect of Time-Restricted Eating in Cardiometabolic Health

University of California (UC) Davis

Status: Terminated

Conditions: Pre-diabetes; Obesity

Treatments: Other: 9 hours daily eating window; Other: 15 hours daily eating window

Study type: Interventional

Funder types: Other

Identifiers

NCT04484987

1521859

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

TRE group

Other group

Description:

Time-restricted eating group

Treatment:

Other: 9 hours daily eating window

Control group

Other group

Description:

Time-unrestricted eating group

Treatment:

Other: 15 hours daily eating window