The Effect of Time-Restricted Eating in Cardiometabolic Health

Obesity Clinical Trial

Official title:

The Effect of Time-Restricted Eating in Cardiometabolic Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04484987
• Other study ID #: 1521859
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 31, 2025
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.	3 months (pre-post intervention)
Primary	24 h glycemic control	Changes in plasma glucose concentration will be assessed during a 24 h feeding study.	3 months (pre-post intervention)
Primary	Adipose tissue gene expression	Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.	3 months (pre-post intervention)
Secondary	Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells	We will evaluate changes in clock gene expression	3 months (pre-post intervention)

External Links

•   Learn more or sign up for the study here!