Clinical trial for Liver Cancer, Adult
Official title Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer
ClinicalTrials.gov ID: NCT06824974
What this study is testing
- What it's testing
- This study is testing whether a nightly fast combined with healthy eating is safe and can improve liver health in adults with liver disease or cancer.
- Who it's for
- You may be able to join if you are an adult with liver disease or cancer and can follow a diet plan.
- What's involved
- You will meet a dietitian for counseling and get phone calls from a health coach. You will also have blood tests. If you are in the control group, you will only have blood tests.
- Time commitment
- The study lasts six months and includes several visits and phone calls for the intervention group, while the control group has only blood tests.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Overweight or obese (BMI 27-45 kg/m2)
- Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD/NAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or...
- English or Spanish speaking over the age of 18.
- ECOG Performance Status ≤ 2.
- Usual nightly fasting \<12 hours
You likely can't join if
- 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
- Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
- Participation in another conflicting study that requires modification of diet or food timing.
See the full eligibility criteria
- 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.
- Usual nightly fasting \<12 hours
- Willing to comply with all study procedures
- Life expectancy of \> 12 months
- 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
- Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
- Participation in another conflicting study that requires modification of diet or food timing.
- Patients on GLP-1 receptor agonists
- Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)
- Medications that markedly impact metabolic study biomarkers.
- Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
- Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.
- Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy
- Active alcohol abuse or less than 6 months of sobriety
- Participation in a trial of an investigational agent within the prior 30 days
- Pregnancy or lactating, positive hCG urine test.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.