The Effect of Time-restricted Eating on Liver Metabolism

Obesity Clinical Trial

— TREL  

Official title:

The Effect of Time-restricted Eating on Liver Metabolism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04997486
• Other study ID #: 1757716
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: September 30, 2024

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 30, 2024
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• NAFLD
• Nutritional and Metabolic Diseases
• Obesity

Intervention

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

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	Change in Intrahepatic triglyceride (IHTG) content	IHTG will be assessed by using MRI	About 12 weeks
Primary	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
Primary	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