NCT07111130

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

Prospective Interventional Study Evaluating the Modulation of Bile Acid Profiles, Gut Microbiome and Liver Health Through Lifestyle Adjustments in Individuals at High Risk of Developing Liver Cancer.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Participants 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. Biological assessments will be conducted at baseline (Visit 1), mid-intervention (Visit 6), and end-of-intervention (Visit 9), including blood sampling for bile acid profiling and stool sampling for gut microbiome sequencing. Liver health evaluation will be conducted at baseline (Visit 1) and end-of-intervention (Visit 9) to assess patient's change in liver health. Extended biological assessments (Visit 10-11) and liver health evaluation through LMS-CT1 imaging (Visit 11) will be performed post-intervention to evaluate the sustainability of the observed changes. Participants will continue to receive standard-of-care surveillance in parallel during the study. In the event of clinical suspicion for hepatocellular carcinoma during surveillance imaging, participants will undergo confirmatory diagnostic imaging and, if diagnosed, will be referred for standard clinical management. Participants diagnosed with HCC during the study will be withdrawn from the active intervention phase. Their data up to the point of diagnosis will be included in analysis, and they will revert to standard-of-care HCC management. Ongoing follow-up for clinical outcomes may continue under the parent ELEGANCE study framework. The study will enrol approximately 90 high-risk NBNC patients identified from the ELEGANCE cohort. Accrual is expected to be completed within 6 to 9 months. The active intervention will last 12 weeks, with subsequent observational follow-up extending up to 12 months post-intervention to assess the durability of metabolic, microbiome, and imaging changes and monitor the incidence of hepatocellular carcinoma.

Conditions

• Liver Diseases

Interventions

Type	Name	Description
OTHER	12-week Lifestyle Intervention	Eligible 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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2025-08-08
• Last updated: 2025-09-23

Locations

14 sites across 1 country: Singapore