Time-Restricted Feeding Attenuates Metabolic Dysfunction-Associated Steatohepatitis and Hepatocellular Carcinoma in Obese Male Mice.
Manasi Das, Deepak Kumar, Consuelo Sauceda...
https://pubmed.ncbi.nlm.nih.gov/38672595Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06824974
Feasibility Study of Time-Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma
Led by University of California, San Diego · Updated on 2025-08-08
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a nutritional intervention designed to improve liver metabolism in adults undergoing liver-directed therapies for hepatocellular carcinoma. This feasibility study aims to determine whether a prolonged nightly fast combined with a healthy diet is safe and practical for patients with liver cancer, as well as its potential effects on liver metabolism. Participants randomized to the intervention group will follow a six-month program that includes time-restricted eating, limiting calorie intake to an 8-10 hour window during the day, along with targeted healthy dietary changes focusing on a plant-based diet. They will receive dietary counseling from a registered dietitian and motivational phone calls from a Certified Health and Wellness Coach to support adherence. The control group will undergo six months of observation without dietary intervention. During the study, participants will be monitored for adherence to the protocol, safety through adverse event reporting, recruitment ability, satisfaction, and self-motivation over six months. Researchers will also assess quality of life, fasting glucose, sleep disturbances, body weight, food frequency, adiposity, physical activity, glucose and insulin levels, ketone production, hemoglobin A1c, plasma leptin, inflammatory cytokines, and fecal microbiome changes. The total participation duration is six months.
CONDITIONS
Brief Title
To Test Whether Time-restricted Eating Coupled With a Healthy Diet is Beneficial in Liver Cancer Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Overweight or obese with BMI between 27 and 45 kg/m2
- Early to intermediate stage hepatocellular carcinoma (BCLC stage)
- Scheduled for liver-directed therapy such as PTA, TACE, or TARE within 3 months
- English or Spanish speaking adults aged 18 or older
- ECOG Performance Status of 2 or less
- Usual nightly fasting less than 12 hours
- Willing to follow all study procedures
- Child-Pugh A liver function
You will not qualify if you...
- Advanced hepatocellular carcinoma, progression, metastatic disease, tumor in vein, or ascites
- Advanced cirrhosis with hypoalbuminemia or Child-Pugh B or C status
- Poorly controlled or severe hepatic encephalopathy (grade 3-4)
- Type 1 diabetes or history of hypoglycemia or hypoglycemic events
- Participation in conflicting studies requiring diet or food timing changes
- Uncontrollable eating patterns such as wasting, Night Eating Syndrome, or food insecurity
- Use of medications that strongly affect metabolic biomarkers
- Other cancers within the last 10 years except certain skin or cervical cancers
- Serious medical conditions like chronic kidney disease or congestive heart failure
- Unresolved toxicity grade 2 or higher from prior anti-cancer therapy
- Active alcohol abuse or less than 6 months of sobriety
- Participation in investigational agent trials within the past 30 days
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 6 months
Participants in the intervention group follow time-restricted eating coupled with a healthy plant-based diet, while the control group is observed without intervention.
Regular visits for monitoring adherence and safety
Trial Site Locations
Total: 1 location
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
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Research Team
N
Nick Webster, PhD
T
Tanya Shekhtman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Obesity, cancer risk, and time-restricted eating.
Manasi Das, Nicholas J G Webster
https://pubmed.ncbi.nlm.nih.gov/35984550