Recruiting

Nutritional Intervention

Sponsor:

UCLA

Code:

NCT06824974

Conditions

Liver Cancer, Adult

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Obesity and Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Time-restricted eating plus healthy diet

Study Details

Brief summary:

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?

Conditions

Liver Cancer, Adult

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Obesity and Overweight

Study ID

NCT06824974

Start date

Aug 1, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Overweight or obese (BMI 27-45 kg/m2)
2. Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD/NAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or liver cancer (BCLC early to intermediate stage HCC)
3. English or Spanish speaking over the age of 18.
4. ECOG Performance Status ≤ 2.
5. Usual nightly fasting <12 hours
6. Willing to comply with all study procedures
7. Life expectancy of > 12 months

Exclusion Criteria:

1. Advanced HCC, progression, and/or associated comorbidities
2. Metastatic disease, tumor in vein, or ascites
3. Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C).
4. Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
5. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
6. Participation in another conflicting study that requires modification of diet or food timing.
7. Patients on GLP-1 receptor agonists
8. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
9. Medications that markedly impact metabolic study biomarkers.
10. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
11. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
12. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
13. Active alcohol abuse or less than 6 months of sobriety
14. Participation in a trial of an investigational agent within the prior 30 days
15. Pregnancy or lactating, positive hCG urine test.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention

Intervention group will follow time-restricted consumption of a healthy diet.

no intervention: Control

Control observational arm.

Interventions

Time-restricted eating plus healthy diet

Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.

Primary outcome measure

  • Adherence to protocol [ Time Frame: 6 months ]
  • Safety from adverse events [ Time Frame: 6 months ]
  • Ability to recruit [ Time Frame: 6 months ]
  • Satisfaction and self-motivation [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Nick Webster, Ph.D., M.A.

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Time-restricted eating
  • healthy diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-25.