The Effect of Time-restricted Eating on Liver Metabolism

NCT04997486 | Completed DMC

• 1 other identifier: 1757716
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NAFLD; Obesity; Nutritional and Metabolic Diseases

Outcome Measures

Primary Outcomes (3)

• Change in Intrahepatic triglyceride (IHTG) content

  IHTG will be assessed by using MRI

  About 12 weeks

• Change in de novo lipogenesis (DNL)

  DNL will be assessed by using administration of deuterated water and measurement of deuterium enrichment in plasma lipids

  About 12 weeks

• Change in glucose, free fatty acid and triglyceride levels in response to a meal

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

  Before and after 12 weeks

Study Arms (3)

Control

NO INTERVENTION

Subjects will consume all meals/snacks during a \~15-h daily eating period (\~9-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance.

TRE isocaloric

EXPERIMENTAL

Subjects will consume all meals/snacks during a \~9-h daily eating period (\~15-h fasting). The prescribed energy intake will be monitored and adjusted as needed to achieve weight maintenance.

Behavioral: Time restricted eating

TRE ad libitum

EXPERIMENTAL

Subjects will consume all meals/snacks during a \~9-h daily eating period (\~15-h fasting) without any other dietary advice.

Behavioral: Time restricted eating

Interventions

Time restricted eating BEHAVIORAL

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

TRE ad libitum; TRE isocaloric

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Davis, California, 95616-5398, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Nutritional and Metabolic Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 9, 2021
• Study Start: July 20, 2021
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)