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TREL: The Effect of Time-restricted Eating on Liver Metabolism

Sponsor
University of California, Davis (Other)
Overall Status
Recruiting
CT.gov ID
NCT04997486
Collaborator
(none)
18
Enrollment
1
Location
3
Arms
14.4
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Time restricted eating
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Time-restricted Eating on Liver Metabolism
Actual Study Start Date :
Jul 20, 2021
Anticipated Primary Completion Date :
Sep 20, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

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.
Experimental: TRE isocaloric

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in Intrahepatic triglyceride (IHTG) content [About 12 weeks]

    IHTG will be assessed by using MRI

  2. Change in de novo lipogenesis (DNL) [About 12 weeks]

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

  3. Change in glucose, free fatty acid and triglyceride levels in response to a meal [Before and after 12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Davis Davis California United States 95616-5398

Sponsors and Collaborators

  • University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT04997486
Other Study ID Numbers:
  • 1757716
First Posted:
Aug 9, 2021
Last Update Posted:
Aug 9, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Metabolic Diseases

Study Results

No Results Posted as of Aug 9, 2021