Restoring Bile Acid Homeostasis Via Lifestyle Adjustments to Prevent the Development of Liver Cancer

Starting soon · Not applicable

Conditions studied: Liver Diseases

In brief

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).

Key facts

Study ID

NCT07111130

Run by

National Cancer Centre, Singapore

People needed

90

Starts

2026-07-01

Expected to finish

2028-03-01

Last updated by the study team

2026-05-15

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following criteria are to be checked at the time of enrolment. The patient may only be included in the study if ALL of the following statements are FULFILLED:
• 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 is able to comply with scheduled visits, assessments and other study procedures.
• Patient is willing to provide informed consent before enrolment in the study.

You may not qualify if…

• The following criteria should be checked at the time of enrolment. If ANY applies, the patient must not be included in the study:
• 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).
• Patient has chronic liver diseases apart from steatosis or compensated cirrhosis (e.g., autoimmune hepatitis, primary biliary cholangitis. etc.).
• Uncontrolled diabetes mellitus requiring special dietary management or persistent unacceptable HbA1c levels.
• Use of weight-loss medications (e.g., GLP-1 agonists, Orlistat) within three months prior to enrolment or planned use during the study period.
• History of bariatric surgery or planned bariatric surgery during the study period.
• Patient has significant comorbidities expected to limit life expectancy to less than one year, or that would render diet or exercise unsafe
• Diseases involving muscles, bones or joints that may impact the subjects' performance during exercise testing and exercise rehabilitation
• Co-morbidities that may adversely affect exercise performance
• Requiring an assistive aid with walking
• Conditions that require strict dietary restrictions or impair ability to follow dietary interventions
• Patient has significant gastrointestinal diseases affecting nutrient absorption or requiring a special diet incompatible with study diet.
• Pregnancy or breastfeeding
• Current use of medications or supplements that significantly alter bile acid gastrointestinal absorption (e.g., bile acid sequestrants) that cannot be safely discontinued.
• Patient has severe food allergies or intolerances incompatible with the provided study diet.
• Patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
• Patient is unable to provide informed consent or refuse blood taking and other investigations including LMS scans.
• Patient has any other condition which, in the opinion of the Investigators, would make the patient unsuitable for enrolment or could interfere with completion of the study.

Where it is running

• National University Hospital — Singapore, Singapore
• SingHealth Polyclinics - Bukit Merah — Singapore, Singapore
• National Cancer Center Singapore — Singapore, Singapore
• SingHealth Polyclinics - Outram — Singapore, Singapore
• Singapore General Hospital — Singapore, Singapore
• Tan Tock Seng Hospital — Singapore, Singapore
• SingHealth Polyclinics - Marine Parade — Singapore, Singapore
• SingHealth Polyclinics - Bedok — Singapore, Singapore
• SingHealth Polyclinics - Pasir Ris — Singapore, Singapore
• SingHealth Polyclinics - Tampines — Singapore, Singapore
• Changi General Hospital — Singapore, Singapore
• Sengkang General Hospital — Singapore, Singapore
• SingHealth Polyclinics - Sengkang — Singapore, Singapore
• SingHealth Polyclinics - Punggol — Singapore, Singapore

Full record on ClinicalTrials.gov

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