An interventional study of Time-restricted eating plus healthy diet in Liver Cancer, Adult, MASH - Metabolic Dysfunction-Associated Steatohepatitis and Obesity and Overweight, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Other
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?
We are proposing a feasibility study that will collect data to assess the potential effect of nutritional intervention in adult patients with liver disease. We hypothesize that a time-restricted, healthy eating intervention is feasible and safe;will improve metabolic and inflammatory biomarkers, and quality of life.
Primary endpoint is to assess feasibility and safety. Feasibility assessment includes recruitment, retention, and satisfaction of subject; data collection efficiency; adherence to TR+HE protocols by dietary logs and/or dietary recalls. Safety assessment includes liver function tests, hypoglycemic episodes, nausea, disrupted sleep, decreased quality of life or other patient reported events from surveys. Secondary endpoint is to assess clinical parameters including quality of Life (SF-36 questionnaire), sleep disturbance (PROMIS-8b), anthropometrics and vitals, food frequency questionnaire, adiposity by dual-energy X-ray absorptiometry (DEXA), physical activity by accelerometer, glucose levels by continuous glucose monitoring, plasma metabolic markers by fasting glucose, insulin, beta-hydroxy-butyrate, Hemoglobin A1C, leptin, and inflammatory cytokines.
This prospective, single-site, open-label controlled clinical trial will enroll up to 70 overweight or obese adults (BMI at least 27, aged 18 years or more) diagnosed with metabolic liver disease up to and including HCC (BCLC early to intermediate stage), and whose usual nightly fasting interval is less than 12 hours.
The trial will have two arms: the Time Restricted + Healthy Eating (TR+HE) group (14-16 h fast with no energy intake after 7 pm), and the Control (CTL) Group. We will randomize the subjects 2:1 to the intervention group versus the control group. Once the intervention group is full, we will direct any new subjects to the control group. The control group is monitoring plus blood draws. If we have difficulty filling the control group we can use historical SOC data. Participants will be assigned to the TR+HE or the CTL group based on the baseline assessment of the usual nightly fasting and subjects willingness to adhere to the intervention.
All subjects will receive standard of care (SOC) treatment, with additional study-related visits for DXA, accelerometry and CGM instructions, blood draws for metabolic and inflammatory panels, and other clinical assessments. Participants will be provided with mail-in stool samplers.
The active intervention arm will start with a nutritional counseling session by the study registered dietician (RD) lasting about 60 minutes. After that, participants will receive up to 3 follow-up sessions by the study RD and brief support phone calls every week from health coach (HC) for the first 3 months of the study. For the following 3 months, the intervention arm will receive daily support prompts provided by a guava-based app and/or bi-weekly phone calls.
The control arm will have the same guava-based app to monitor their eating habits, but will follow their usual eating patterns and diet.
Study Schedule and Assessments
Month 0 Enrollment/Baseline Assessment:
The study coordinator will schedule an in-person or virtual visit to administer the informed consent form and to enroll participants. This visit will include collection of demographics and baseline questionnaires (FFQ, SF-36 and PROMIS-8B). Participants will also be asked to complete a 3-day dietary journal to assess their usual diet and estimate their usual nightly fasting duration and food frequency questionnaire (VioScreen).
The study coordinator will then schedule an in-person visit at the Exercise and Physical Activity Resource Center for a pregnancy test, a DXA scan, vitals and anthropometrics measures, and a blood draw for biomarkers. During this visit, participants will receive an accelerometer and continuous glucose monitor (CGM) to be worn for 7 days. The continuous glucose monitoring will be used to check for hypoglycemic events before starting the intervention. LFT standard-of-care labs may be extracted from the medical chart. Participants will also be provided with mail-in stool collection kits and will be provided with and enrolled in the Guava Health app.
Guava is a phone app that allows individuals to monitor their health data, physical activity and nutrition. Guava can connect to health and fitness devices like CGMs and Fitbits and can interface with the patients EMR. This allows individuals to log food consumed using the smart phone camera or text input, medications, weight, exercise, and blood pressure. The data synching with the EMR also allows individuals to monitor relevant health information, up coming visits, lab results etc. The app will provide reminders, and other engagement levers, to encourage subjects to follow their recommended eating intervals and diets. The study team will monitor the Guava Dashboard for compliance and will reach out to participants as needed. At the end of the study, consented data will be exported from the app to the research team as a spreadsheet for analysis. Subjects will be provided with a contact should they need help with the app.
The Guava team have developed a Dashboard that the study team can access at any time during the trial. Study team will monitor Guava Dashboard for compliance and will reach out to participants as needed. At the end of the study, consented data will be exported back to the research team for analysis.
The study coordinator will then schedule a virtual visit with the study RD, and a virtual visit with the study HC. Participants in the intervention group will receive instruction on achieving and maintaining a healthy diet with prolonged nightly fasting of 14-16 h.
Intervention starts after completion of baseline visit including the CGM and accelerometer reporting. Intervention will continue up to 6 months.
During the first three months, participants in the nutritional intervention group will be followed up monthly by the study RD through virtual visits to perform the dietary intake and schedule collection and diet course corrections, and weekly by the study HC to reinforce the change, address challenges, and encourage accomplishments.
Month 3 Visit: Participants will complete study questionnaires (FFQ, SF-36, PROMIS-8B, and diet journal) and meet with the study coordinator for anthropometrics (BMI, WC) measures and stool and blood samples collection. Blood will be used for measuring insulin, glucose, liver enzymes, and a panel of inflammatory cytokines; stool will be used to isolate microbial DNA. LFT standard-of-care labs may be extracted from the medical chart.
Month 6 Visit:
The study coordinator will schedule a visit to collect study questionnaires (FFQ, SF-36, PROMIS-8B, and diet journal) and samples; measure anthropometrics and vitals; perform a DXA scan and provide participants with an accelerometer and glucose monitor to be worn for 7 days. LFT standard-of-care labs may be extracted from the medical chart. The 6-month visit marks the end of the active intervention.
Month 12 Visit: Participants will complete study questionnaires (FFQ, SF-36, PROMIS-8B, and diet journal) and meet with the study coordinator for anthropometrics (BMI, WC), a blood draw and collection of stool samples. LFT standard-of-care labs may be extracted from the medical chart.
Collection of Data Identifier: participant name, DOB, MRN Demographics: gender, age, race, contact information, tobacco and alcohol use, marital status, education, employment status, household income Clinical: SF-36, PROMIS-8B, DXA, standard-of-care liver images and liver function tests, vitals in EPIC Nutritional: FFQ, Diet journals and/or food recalls, continuous glucose monitoring data Physical activity: accelerometry data Specimens: plasma metabolic and inflammatory biomarkers, stool samples
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 50 is close to the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention group will follow time-restricted consumption of a healthy diet.
Behavioral: Time-restricted eating plus healthy diet
Control observational arm.
Subjects will restrict calorie consumption to 8-10 hours during the day plus will follow a healthy plant-based diet.
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
Effect of intervention on Quality of Life
Quality of Life will be assessed using the EORTC QLQ C-30 questionnaire for Cancer patients
Time frame: 6 months
Effect of interventions on fasting glucose
Fasting glucose will be measured at baseline and 6 months
Time frame: 6-months
Sleep disturbance
Sleep disturbance as reported by the PROMIS-8b survey
Time frame: 6 months
Effect of intervention on body weight
Body weight will be measured prior to and during intervention
Time frame: 6 months
Effect of intervention on food frequency
Participants will complete a Food frequency questionnaire at Baseline, 3 months and 6 months
Time frame: 6 months
Effect of intervention on Adiposity
Adiposity will be measured by Dual-energy X-ray Absorptiometry (DXA) at baseline and at 6 months
Time frame: 6 months
Effect of interventions on Physical activity
Physical activity will be measured by Accelerometer mounted at the waist at baseline and at 6 months
Time frame: 6 months
Effect of intervention on Glucose levels
Glucose levels will be monitored by Continuous Glucose Monitoring at baseline and at 6 months
Time frame: 6 months
Effect of intervention on fasting insulin
Fasting insulin levels will be measured at baseline and at 6 months
Time frame: 6 months
Effect of intervention on ketone production
Fasting beta-hydroxybutyrate levels will be measured at baseline and 6 months
Time frame: 6 months
Effect of interventions on hemoglobin A1c
Hemoglobin A1c will be measured at baseline and 6 months
Time frame: 6 months
Effect of intervention on plasma leptin
Leptin levels will be measured at baseline and 6 months
Time frame: 6 months
Effect of intervention on inflammatory cytokines
Inflammatory cytokines will be measured at baseline and 6 months
Time frame: 6 months
Effect of intervention on fecal microbiome
7S sequencing will be performed on fecal samples at baseline and 6 months
Time frame: 6 months
Plan to share: No
Started Aug 2025 (actual). Primary completion is estimated for Dec 2027, 28 months after the start.
Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 28 months is below that.
Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
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