Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

Study Overview
=================
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.

Official Title
-----------------
Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - A Randomized Controlled Trial

Conditions
-----------------
Nonalcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Other: Low glycemic index dietary intervention program
* Other: simple lifestyle advice


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low glycemic index dietary intervention program<br>The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved. | Other: Low glycemic index dietary intervention program<br>* The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.<br>|
| Placebo Comparator: Simple lifestyle advice<br>The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice. | Other: simple lifestyle advice<br>* The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of NAFLD by proton-magnetic resonance spectroscopy |  | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial resolution of NAFLD |  | Month 12 | 
| Visceral fat measurement |  | Month 12 | 
| Liver fibrosis by transient elastography |  | Month 12 | 
| Metabolic endpoints |  | Month 12 |