Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06824974

Recruiting nowNot applicableInterventional

What this study is about

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?

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionLiver Cancer, Adult, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Obesity and Overweight

Full registry 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.

Treatments and study arms

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.

Primary outcomes

Adherence to protocol6 months

Participant adherence to and comprehension of the protocol as an indicator of intervention delivery by staff. Adherence will be assessed by the number of participants who complete the study, the percentage of days with fasting \>14 h, and the number of days that food was logged into the app.

Safety from adverse events6 months

Safety assessed by adverse events and liver function tests. Reports on adverse events will include hypoglycemic epidoes, nausea, disrupted sleep, decreased quality of life or other patient reported events from surveys. Liver function tests (AST and ALT) as well ss platelet count and total protein are monitored under SOC. AST and ALT elevation will be considered mild if 2-5 times upper limit normal (ULN), moderate if 5-15 times ULN, and severe if \>15 times ULN.

Ability to recruit6 months

Ability to recruit our target population will be assessed by the number of eligible individuals in the patient population, and the number who enroll in the trial.

Satisfaction and self-motivation6 months

We will determine the degree to which participants liked the intervention through satisfaction surveys at the end of the study and the number of participants who demonstrate self-motivation to continue the intervention protocol during 6-month follow-up.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of California San Diego🇺🇸 La Jolla, California, United States
Nick WebsterContact
Nick Webster, Ph.D., M.A.Principal Investigator