Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty Liver Disease

NCT05741957 | Active Not Recruiting

• 1 other identifier: HKU-NFF
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity recommendations.

Conditions

Non-Alcoholic Fatty Liver Disease; Obesity

Keywords

Non-Alcoholic Fatty Liver Disease; Overweight; Central Obesity; Obesity; Adults; Aerobic Exercise; Exercise Frequency

Outcome Measures

Primary Outcomes (1)

• Change in Liver Fat

  Intrahepatic triglycerides will be assessed using proton magnetic resonance spectroscopy (1H-MRS) in a 3×3×3 cm voxel.

  Baseline and 4 months (post-intervention)

Secondary Outcomes (9)

• Change in Liver Fat

  Baseline and 10 months (follow-up)

• Change in Abdominal Visceral Fat

  Baseline, 4 months (post-intervention), and 10 months (follow-up)

• Change in Body Fat

  Baseline, 4 months (post-intervention), and 10 months (follow-up)

• Change in Body Mass Index

  Baseline, 4 months (post-intervention), and 10 months (follow-up)

• Change in Waist Circumference

  Baseline, 4 months (post-intervention), and 10 months (follow-up)

Study Arms (3)

Once-a-week Exercise

EXPERIMENTAL

Once-a-week vigorous-intensity exercise for 4 months.

Behavioral: Once-a-week Exercise

Thrice-a-week Exercise

EXPERIMENTAL

Thrice-a-week vigorous-intensity exercise for 4 months.

Behavioral: Thrice-a-week Exercise

Usual Care Control

OTHER

Bi-weekly health education for 4 months.

Other: Usual Care Control

Interventions

Once-a-week Exercise BEHAVIORAL

Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve one session weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 75 min. Participants will exercise with an exercising heart rate at 6-7 metabolic equivalents (METs). Health information provided to the usual care control group will be made available to the participants in this group.

Once-a-week Exercise

Thrice-a-week Exercise BEHAVIORAL

Participants in this group will participate in a supervised treadmill exercise program delivered by certified fitness instructors. The prescribed program will involve three sessions weekly for 4 months, and the duration of vigorous-intensity treadmill exercise per session will be 25 min. Participants will exercise with an exercising heart rate at 6-7 METs. Health information provided to the usual care control group will be made available to the participants in this group.

Thrice-a-week Exercise

Usual Care Control OTHER

Participants in this group will receive health education delivered by research personnel. This program will consist of eight two-hour bi-weekly sessions covering major health issues relating to general health and NAFLD, such as non-communicable diseases, infectious diseases, and a healthy lifestyle.

Usual Care Control

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cantonese, Mandarin, or English speaking Chinese;
• Aged 18-69;
• Male or female;
• Centrally obese according to the Asian-specific cut-off (waist circumference ≥90 cm for males; ≥80 cm for females) and with BMI ≥23;
• With NAFLD (defined as \>5% intrahepatic triglycerides assessed by 1H-MRS);
• Willing to participate in exercise training to improve NAFLD.

You may not qualify if:

• 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, therapy, or medication for obesity or weight loss in the past 6 months (e.g., gastric bypass, gastric band, sleeve gastrectomy, gastric reduction duodenal switch, or dietitian-prescribed dietary program);
• Physical changes that considerably affect body composition and weight (e.g., anorexia nervosa, bulimia nervosa, prolonged gastrointestinal and digestive disorders) during the study period.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

LKS Faculty of Medicine

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Overweight; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Parco M. Siu, PhD

  LKS Faculty of Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Division Head

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: March 2, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years following the publication of the article.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Proposals should be directed to pmsiu@hku.hk to gain access and for data request, a data-access agreement needs to be signed.

Locations

HK (1)