The Effect of Time-Restricted Eating in Cardiometabolic Health

STATUS

Recruiting
End date

Sep 5, 2025
participants needed

100
sponsor

University of California, Davis

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Updated on 19 February 2024

See if I qualify

body mass index

insulin

glycosylated hemoglobin

hba1c

plasma glucose

cardiovascular disease

fasting

insulin sensitivity

hemoglobin a1c

manipulation

glucose intolerance

caloric restriction

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.

Details

Condition	Prediabetes, Obesity, Obesity
Age	25years - 70years
Treatment	9 hours daily eating window, 15 hours daily eating window
Clinical Study Identifier	NCT04484987
Sponsor	University of California, Davis
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	body mass index 27-40 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
	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

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The Effect of Time-Restricted Eating in Cardiometabolic Health