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Behavioral Intervention
Time-Restricted Eating for Liver Cancer (TRE+HE Trial)
La Jolla, CA
N/A
Waitlist Available
Led By Nick Webster, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child-Pugh A liver function
Overweight or obese (BMI 27-45 kg/m2)
Must not have
Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM
Advanced HCC, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
No Placebo-Only Group
Summary
"This trial will study the effects of a nutritional program on liver metabolism in patients with liver cancer. Participants will either follow a specific eating plan with restricted eating hours or be observed for six months. The main
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Who is the study for?
This trial is for adults with liver cancer, specifically hepatocellular carcinoma, who may also be overweight or have fatty liver disease. Participants should be undergoing liver-directed therapies and willing to follow a nutritional program including time-restricted eating and diet changes.Check my eligibility
What is being tested?
The study tests if limiting eating to an 8-10 hour window daily combined with a healthy diet can improve liver metabolism in liver cancer patients. It includes dietary counseling and motivational support versus a control group under observation only.See study design
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects may include hunger outside of the eating window, potential nutrient deficiencies if not properly managed, and possible adjustment discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver functions well despite my condition.
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My BMI is between 27 and 45.
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My liver cancer is in an early to intermediate stage.
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I can take care of myself but might not be able to do heavy physical work.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have type 1 diabetes or have experienced low blood sugar.
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My liver cancer is advanced, has spread, or caused other health issues.
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I have severe liver disease with complications.
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I do not have serious conditions like kidney disease or heart failure that would stop me from joining the trial.
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I have lasting side effects from cancer treatment that are moderate or worse.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ability to recruit
Adherence to protocol
Safety from adverse events
+1 moreSecondary study objectives
Effect of intervention on Adiposity
Effect of intervention on Glucose levels
Effect of intervention on Quality of Life
+11 moreOther study objectives
Disease progression as a Tertiary/Exploratory outcome
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Intervention group will follow time-restricted consumption of a healthy diet.
Group II: ControlActive Control1 Intervention
Control observational arm.
Find a Location
Closest Location:University of California San Diego· La Jolla, CA· 1958 miles
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,212 Previous Clinical Trials
1,593,064 Total Patients Enrolled
54 Trials studying Obesity
7,526 Patients Enrolled for Obesity
Nick Webster, PhDPrincipal InvestigatorUniversoty of California San Diego