Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

Not Applicable

Completed

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Other: Low glycemic index dietary intervention program; Other: simple lifestyle advice

• Registration Number: NCT00868933
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low glycemic index dietary intervention program	Low glycemic index dietary intervention program	The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.
Simple lifestyle advice	simple lifestyle advice	The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.

Primary Outcome Measures

Name	Time	Method
Resolution of NAFLD by proton-magnetic resonance spectroscopy	Month 12

Secondary Outcome Measures

Name	Time	Method
Partial resolution of NAFLD	Month 12
Visceral fat measurement	Month 12
Liver fibrosis by transient elastography	Month 12
Metabolic endpoints	Month 12

Trial Locations

Locations (1)

Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China