The Effect of Time-Restricted Eating in Cardiometabolic Health

Sponsor

University of California, Davis (Other)

Overall Status

Recruiting

CT.gov ID

NCT04484987

Collaborator

(none)

100

Enrollment

Location

Arms

54.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Pre-diabetes	Other: 9 hours daily eating window Other: 15 hours daily eating window	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Effect of Time-Restricted Eating in Cardiometabolic Health

Actual Study Start Date :

Nov 20, 2020

Anticipated Primary Completion Date :

May 20, 2025

Anticipated Study Completion Date :

May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: TRE group Time-restricted eating group	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.
Other: Control group Time-unrestricted eating group	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.

Arm

Intervention/Treatment

Other: TRE group

Time-restricted eating group

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.

Other: Control group

Time-unrestricted eating group

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.

Outcome Measures

Primary Outcome Measures

Insulin sensitivity [3 months (pre-post intervention)]
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
24 h glycemic control [3 months (pre-post intervention)]
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Adipose tissue gene expression [3 months (pre-post intervention)]
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.

Secondary Outcome Measures

Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells [3 months (pre-post intervention)]
We will evaluate changes in clock gene expression

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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