Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06824974
Status
Recruiting
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Conditions

  • Liver Cancer, Adult
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis
  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Time-restricted eating plus healthy diet — BEHAVIORAL
    Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.

Study Details

This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This prospective single-site trial will enroll adult patients with liver diseases such as metabolic-dysfunction associated steatotic liver disease (MASLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis and/or hepatocellular carcinoma (HCC). Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating plus targeted healthy changes in what they eat (TR-HE). The intervention includes dietary counseling visits with a study registered dietitian (RD) and motivational phone calls with a study Certified Health and Wellness Coach (HC). Individuals who are randomized to the control group or who elect to join the control group will be enrolled in a six-month period of observation and phlebotomy only. The main questions it aims to answer are: Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver disease or cancer? Does the intervention improve liver metabolism?

Key Dates

First listed
Feb 13, 2025
Start date
Aug 1, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention
    Intervention group will follow time-restricted consumption of a healthy diet.
  • No Intervention: Control
    Control observational arm.

Primary Outcome Measure

Adherence to protocol [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093
Nick Webster
[email protected]
8585346275
Nick Webster, Ph.D., M.A. (PRINCIPAL_INVESTIGATOR)

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