Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer
Recruiting · NCT06824974 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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?
Who can take part
Inclusion criteria
- Overweight or obese (BMI 27-45 kg/m2)
- Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD/NAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or liver cancer (BCLC early to intermediate stage HCC)
- English or Spanish speaking over the age of 18.
- ECOG Performance Status ≤ 2.
- Usual nightly fasting \<12 hours
- Willing to comply with all study procedures
- Life expectancy of \> 12 months
Exclusion criteria
- Advanced HCC, progression, and/or associated comorbidities
- Metastatic disease, tumor in vein, or ascites
- Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C).
- Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
- Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
- Participation in another conflicting study that requires modification of diet or food timing.
- Patients on GLP-1 receptor agonists
- Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
- Medications that markedly impact metabolic study biomarkers.
- Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
- Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
- Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
- Active alcohol abuse or less than 6 months of sobriety
- Participation in a trial of an investigational agent within the prior 30 days
- Pregnancy or lactating, positive hCG urine test.
Where it is running
1 location listed across 1 US state.
- University of California San Diego - La Jolla, California, United States