Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
Summary
This is a feasibility study that will collect data to assess the potential effect of a nutritional intervention designed to improve liver metabolism. This prospective single-site trial will enroll adult patients undergoing liver-directed therapies for hepatocellular carcinoma. Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating in which calorie consumption is limited to 8-10 hours during the day, plus targeted healthy changes in what they eat. The intervention includes dietary counseling visits with a study registered dietitian and motivational phone calls with a study Certified Health and Wellness Coach to help subjects adhere to the intervention. Individuals in the control group will be enrolled in a six-month period of observation 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 cancer? Does the intervention improve liver metabolism?
Arms & interventions
- BehavioralTime-restricted eating plus healthy diet
Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.
Outcome measures
Primary
Adherence to protocol
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.
Time frame: 6 months
Safety from adverse events
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.
Time frame: 6 months
Ability to recruit
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.
Time frame: 6 months
Satisfaction and self-motivation
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.
Time frame: 6 months
Secondary
Effect of intervention on Quality of Life
Time frame: 6 months
Effect of interventions on fasting glucose
Time frame: 6-months
Sleep disturbance
Time frame: 6 months
Effect of intervention on body weight
Time frame: 6 months
Effect of intervention on food frequency
Time frame: 6 months
Effect of intervention on Adiposity
Time frame: 6 months
Effect of interventions on Physical activity
Time frame: 6 months
Effect of intervention on Glucose levels
Time frame: 6 months
Effect of intervention on fasting insulin
Time frame: 6 months
Effect of intervention on ketone production
Time frame: 6 months
Effect of interventions on hemoglobin A1c
Time frame: 6 months
Effect of intervention on plasma leptin
Time frame: 6 months
Effect of intervention on inflammatory cytokines
Time frame: 6 months
Effect of intervention on fecal microbiome
Time frame: 6 months
Eligibility criteria
Study locations (1)
University of California San Diego
La Jolla, California, 92093
References
- Das M, Kumar D, Sauceda C, Oberg A, Ellies LG, Zeng L, Jih LJ, Newton IG, Webster NJG. Time-Restricted Feeding Attenuates Metabolic Dysfunction-Associated Steatohepatitis and Hepatocellular Carcinoma in Obese Male Mice. Cancers (Basel). 2024 Apr 16;16(8):1513. doi: 10.3390/cancers16081513.(PubMed)
- Das M, Webster NJG. Obesity, cancer risk, and time-restricted eating. Cancer Metastasis Rev. 2022 Sep;41(3):697-717. doi: 10.1007/s10555-022-10061-3. Epub 2022 Aug 19.(PubMed)