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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Time-restricted eating plus healthy diet

Treatment groups

50 Participants
are divided into 2 treatment groups