Time-restricted Eating and Healthy Eating for Liver Disease and Cancer
This study is looking at whether a nutritional plan called "time-restricted eating plus healthy diet" (TR-HE) is a practical and safe approach for adults with certain liver conditions, including metabolic-dysfunction associated steatotic liver disease (MASLD/NAFLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis, or liver cancer. TR-HE involves eating only during an 8-10 hour window each day and following a healthy, plant-based diet. Participants will receive dietary counseling and motivational phone calls. The main goal is to see if people can stick to this plan, if it's safe, and if the study can successfully enroll participants. The study is currently enrolling about 50 people, but its overall status is unclear.
- Study design
- This is a single-site study that plans to enroll about 50 adult participants. It is an interventional study, meaning participants will receive a specific intervention.
- What's involved
- If you are in the intervention group, you would participate in a six-month nutritional change program with dietary counseling visits and motivational phone calls.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study, including adherence and safety, will be measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nick Webster, PhD · PRINCIPAL_INVESTIGATOR · Universoty of California San Diego
Who to contact
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What this trial measures
- 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.