RightFit
RecruitingNot applicable

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

Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits, 6 visits, 12 visits
  • Time periods mentioned: 7 days, 6 months
  • Procedures mentioned: Phone or video check-ins, Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "Safety assessment includes liver function tests, hypoglycemic episodes, nausea, disrupted sleep, decreased quality of life or other patient reported events from surveys."
  • "The control group is monitoring plus blood draws."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a longer overnight break from eating plus healthy food changes is safe and doable, and whether it helps the liver process food. It is for adults with excess weight who have certain liver diseases or liver cancer. For six months, participants either follow the eating program with coaching or have observation and blood draws only.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a BMI of 27–45, a measure of weight compared with height.
  • Have fatty liver disease linked to problems with how the body uses food, liver inflammation from this disease, cirrhosis (liver scarring), or early- to middle-stage liver cancer.
  • Be older than 18 and speak English or Spanish.
  • Be able to care for yourself and be out of bed or a chair for more than half the day (ECOG score 0–2).
  • Usually go less than 12 hours overnight without eating.
  • Be willing to follow all study steps.
  • Be expected to live more than 12 months.

Who can't join

  • Have advanced or worsening liver cancer or related health problems; cancer that has spread, a tumor in a vein, or fluid buildup in the belly.
  • Have advanced liver scarring with low blood protein or Child-Pugh class B or C, or severe confusion from liver disease that is poorly controlled or does not improve with treatment.
  • Have type 1 diabetes or low blood sugar reported by you or found by a continuous glucose monitor.
  • Take GLP-1 medicines or medicines that strongly affect the body measurements being studied; join a conflicting diet study; or have joined a trial of an experimental drug within the past 30 days.
  • Have eating patterns that cannot be controlled, such as severe weight and muscle loss, night eating, disordered eating, or not having reliable access to food.
  • Have had another cancer in the past 10 years, except nonmelanoma skin cancer or cancer limited to the surface of the cervix.
  • Have a serious illness, such as long-term kidney disease or heart failure, that could interfere with the study; or still have moderate or worse side effects from past cancer treatment.
  • Currently misuse alcohol or have been sober for less than six months; or be pregnant, breastfeeding, or have a positive urine pregnancy test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Overweight or obese (BMI 27-45 kg/m2) 2. Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD/NAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or liver cancer (BCLC early to intermediate stage HCC) 3. English or Spanish speaking over the age of 18. 4. ECOG Performance Status ≤ 2. 5. Usual nightly fasting \<12 hours 6. Willing to comply with all study procedures 7. Life expectancy of \> 12 months Exclusion Criteria: 1. Advanced HCC, progression, and/or associated comorbidities 2. Metastatic disease, tumor in vein, or ascites 3. Advanced Cirrhosis (hypoalbuminemia/Child-Pugh B+C). 4. Poorly controlled or refractory (grade 3-4) hepatic encephalopathy 5. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM 6. Participation in another conflicting study that requires modification of diet or food timing. 7. Patients on GLP-1 receptor agonists 8. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity) 9. Medications that markedly impact metabolic study biomarkers. 10. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ) 11. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial. 12. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy 13. Active alcohol abuse or less than 6 months of sobriety 14. Participation in a trial of an investigational agent within the prior 30 days 15. Pregnancy or lactating, positive hCG urine test.

Study sites (1)

CA