The Effect of Time-restricted Eating on Liver Metabolism

Numerous studies have established the role of nutrition on obesity and its related metabolic diseases, which together affect a billion individuals worldwide. Evidence indicate that meal timing regulates numerous metabolic processes suggesting that meal time manipulation may be a simple intervention against obesity and its metabolic diseases. Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-10 h/day with no energy intake the rest of the day. In rodents, TRE significantly decreases hepatic steatosis and dyslipidemia, while it supports a healthier hepatic cellular content even without caloric restriction, potentially by alternating activation of nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on liver health in people is not clear. Accordingly, we will conduct a randomized controlled trial in people with overweight/obesity and hepatic steatosis to determine the effect of 9 h TRE for 12 weeks, on key metabolic outcomes in liver health: 1) intrahepatic triglyceride content using magnetic resonance imaging; 2) de novo lipogenesis during fasting and postprandial conditions using administration of deuterated water in conjunction with mathematical modeling. The proposed study will enable us to determine the effect of meal timing on metabolic function in people with NAFLD.

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Key information

Conditions

NAFLD Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616-5398, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age 25-75 years
men and women
body mass index 25-45 kg/m2
clinical diagnosis of NAFLD
self-reported habitual eating period more than or equal to 14 h per day.

Exclusion criteria

shift worker, recent or expected travel crossing time zones
fasting >12-h/day more than once a week

*> once a week no food intake after 18:00

habitually waking up before 04:00 and sleeping before 22:30
unstable weight (>5% change in the last 2 months)
diabetes mellitus or alcoholic liver disease
sleep disorder
history of or current eating 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
smoking or illegal drug use
pregnant or breastfeeding
having metals in the body
cognitive impairment
gastrointestinal or bariatric surgery that affects nutrient digestion and absorption unable to grant voluntary informed consent or comply with the study instructions individuals who are not yet adults (infants, children, teenagers)
individuals that are unable to lie motionless on the MRI scanner for an hour or *have tattoos or tattooed eyeliner
alcohol abuse
prisoners

Treatment and study plan

Time restricted eating

Behavioral

Participants will be asked consume all meals/snacks during a ~9-h daily eating period (~15-h fasting).

Primary outcomes

Change in Intrahepatic triglyceride (IHTG) content

Time frame: About 12 weeks

IHTG will be assessed by using MRI
Change in de novo lipogenesis (DNL)

Time frame: About 12 weeks

DNL will be assessed by using administration of deuterated water and measurement of deuterium enrichment in plasma lipids
Change in glucose, free fatty acid and triglyceride levels in response to a meal

Time frame: Before and after 12 weeks

Postprandial metabolic homeostasis will be assessed by using a mixed meal tolerance test.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Acronym: TREL

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Aug 9, 2021
Registry last updated: Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed