NCT06824974 Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer
| NCT ID | NCT06824974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Liver Cancer, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
Eligibility Criteria
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.
Contact & Investigator
Nick Webster, PhD
PRINCIPAL INVESTIGATOR
Universoty of California San Diego
Frequently Asked Questions
Who can join the NCT06824974 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06824974 currently recruiting?
Yes, NCT06824974 is actively recruiting participants. Contact the research team at nwebster@health.ucsd.edu for enrollment information.
Where is the NCT06824974 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT06824974 clinical trial?
NCT06824974 is sponsored by University of California, San Diego. The principal investigator is Nick Webster, PhD at Universoty of California San Diego. The trial plans to enroll 50 participants.
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