This is a prospective, single-arm, non-randomized interventional study nested within the existing ELEGANCE cohort. Patients eligible for the RE-BALANCE study will be selected from the ELEGANCE cohort based on predefined high-risk criteria, specifically a low 12-non-hydroxy/12-hydroxy bile acid ratio indicative of elevated hepatocarcinogenic risk.
The study comprises Baseline Assessments (Visit 1), Intervention Visits (Visit 2-8), and Follow-up Assessments (Visit 9-11).
The patient is an existing participant of the ELEGANCE study and shows no evidence of hepatocellular carcinoma (HCC) at the time of enrolment into RE-BALANCE.
Male and female patients aged 50 to 90 years at the time of informed consent are eligible. However, patients with cirrhosis may be included if they are aged 40 to 90 years.
Negative for hepatitis B surface antigen (HBsAg) and hepatitis C antibody
High-risk bile acid profile, defined as a 12-non-hydroxy/12-hydroxy bile acid ratio below the threshold determined from ELEGANCE cohort data.
Patient with confirmed diagnosis of HCC by the American Association for the Study of the Liver Disease (AASLD) imaging criteria or histology / cytology within the last 5 years.
Patient with Child Pugh C or decompensated cirrhosis at time of enrolment (based on the judgement of the Investigator).
Patient with active hepatic encephalopathy at time of enrolment.
Patient is known to be positive for the Human Immunodeficiency Virus (HIV).
Single group
12-week Lifestyle Intervention
Other interventionEligible participants within the existing ELEGANCE cohort will undergo a structured 12-week lifestyle intervention comprising a low-carbohydrate, high-fibre dietary plan and a prescribed physical activity program targeting at least 150 minutes of moderate-intensity exercise per week. Standardized meal provision and wearable fitness tracking devices will be used to support adherence throughout the intervention period.
Hepatocarcinogenic risk change in relation to metabolomics profile.
Change in the bile acid profile pre- and post-intervention.
Hepatocarcinogenic risk change in relation to metagenomics profile.
Change in the gut microbiome alpha and beta diversity pre- and post-intervention.
Hepatocarcinogenic risk change in relation to liver health profile.
Change in the hepatic steatosis and fibrosis as measured by LMS-CT1 MRI pre- and post-intervention.
Sustained change in hepatocarcinogenic risk in relation to metabolomics profile.
Sustained change in the bile acid profile post-intervention.
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National Cancer Centre, Singapore
Lead sponsor
Perspectum
Collaborator
BUZUD Pte Ltd
Collaborator
Asian Microbiome Library (AMiLi) Pte Ltd
Collaborator
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