The Effect of Time-Restricted Eating in Cardiometabolic Health

NCT ID: NCT04484987

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2024-05-20

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 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.

Conditions

Obesity; Pre-diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TRE group

Time-restricted eating group

Group Type: OTHER

9 hours daily eating window

Intervention Type: OTHER

Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.

Control group

Time-unrestricted eating group

Group Type: OTHER

15 hours daily eating window

Intervention Type: OTHER

Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.

Interventions

9 hours daily eating window

Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.

Intervention Type: OTHER

15 hours daily eating window

Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, Davis

Davis, California, United States

Countries

United States

Related Links

https://studypages.com/s/a-study-of-time-restricted-eating-on-heart-health-metabolism-306499/

Learn more or sign up for the study here!

Other Identifiers

1521859

Identifier Type: -

Identifier Source: org_study_id