Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in affluent countries. It may progress to cirrhosis and liver cancer. At present, there is no approved drug for NAFLD. Although healthy diet and exercise is often recommended, there is little supportive evidence. Therefore, the investigators plan to conduct a randomized controlled trial comparing a low glycemic index dietary intervention program and simple lifestyle advice in NAFLD patients. The primary endpoint is resolution of NAFLD. Non-invasive tests will be used to assess the study subjects. Proton-magnetic resonance spectroscopy is used to quantify hepatic triglyceride content, and transient elastography is used to quantify liver fibrosis.
Interventions
OTHERLow glycemic index dietary intervention program
The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.
The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * Fatty liver by proton-magnetic resonance spectroscopy, defined as hepatic triglyceride content 5% or above * Serum alanine aminotransferase (ALT) above 30 U/L in men and 19 U/L in women * Informed written consent obtained
Exclusion criteria
* Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160 * Alcohol consumption above 30 g per week in men or 20 g per week in women * Alanine aminotransferase (ALT) above 10 times the upper limit of normal * Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 10e9/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices * Evidence of hepatocellular carcinoma * Terminal illness or cancer, unless in complete remission for more than 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of NAFLD by proton-magnetic resonance spectroscopy | Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Partial resolution of NAFLD | Month 12 |
| Visceral fat measurement | Month 12 |
| Liver fibrosis by transient elastography | Month 12 |
| Metabolic endpoints | Month 12 |
Countries
China
Outcome results
None listed