Comparing vigorous and moderate exercise to reduce liver fat in obese adults with NAFLD

Vigorous- Versus Moderate-intensity Exercise to Reduce Liver Fat in Adults With Obesity and Non-alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Equivalence Trial

This study is testing whether vigorous exercise can reduce liver fat just as well as moderate exercise in obese adults with non-alcoholic fatty liver disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 330 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: The University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06124456 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of vigorous versus moderate-intensity exercise in reducing liver fat in adults with obesity and non-alcoholic fatty liver disease (NAFLD). Participants will be randomly assigned to either a vigorous or moderate exercise regimen, both aligned with the World Health Organization's physical activity recommendations. The goal is to determine if vigorous exercise can provide similar benefits to moderate exercise while requiring less time commitment. This research aims to establish evidence-based exercise guidelines for managing NAFLD, which currently lacks licensed drug treatments.

Who should consider this trial

Good fit: Ideal candidates are Cantonese, Mandarin, or English-speaking Chinese adults aged 18-69 with obesity and diagnosed NAFLD.

Not a fit: Patients with a history of regular exercise training, significant medical conditions, or impaired mobility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with effective exercise guidelines to manage NAFLD and obesity more efficiently.

How similar studies have performed: While exercise is a known intervention for NAFLD, this specific comparison of exercise intensities is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Cantonese, Mandarin, or English-speaking Chinese,
* aged 18-69,
* centrally obese according to the Asia-specific cut-off (waist circumference 90 cm for males, 80 cm for females) and BMI ≥23 (i.e., overweight as defined by the Hong Kong government),
* with NAFLD (defined as \>5% intrahepatic triglycerides assessed by 1H-MR spectroscopy),
* able to perform the prescribed exercise program. Both men and women will be included to enhance generalizability.

Exclusion Criteria:

* regular exercise training (\>3 sessions of \>60 min of moderate-intensity exercise training weekly) in the past 6 months,
* medical history of cardiovascular disease, chronic pulmonary or kidney disease, heart failure, cancer, and/or liver disease except NAFLD,
* somatic conditions that limit exercise participation (e.g., limb loss),
* impaired mobility due to chronic disease (e.g., chronic arthritis/osteoarthritis, neurological, musculoskeletal, and autoimmune diseases),
* daily smoking habit,
* excess alcohol consumption (daily ≥20 g of alcohol for men and ≥10 g for women) in the past 1 year,
* consumption of certain drugs (e.g., tamoxifen and estrogen) known to be secondary causes of steatosis,
* surgery and therapy for morbid obesity in the past 6 months and during the study period (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, or dietitian-prescribed dietary program).

Where this trial is running

Hong Kong

• LKS Faculty of Medicine — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Parco M Siu, PhD — LKS Faculty of Medicine, The University of Hong Kong
• Study coordinator: Parco M Siu, PhD

Conditions: Obesity, NAFLD, Liver Fat, exercise