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Completed

NCT Number: NCT00868933

Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong SAR, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low glycemic index dietary intervention program

Other

The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.

simple lifestyle advice

Other

The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.

Primary outcomes

  1. Resolution of NAFLD by proton-magnetic resonance spectroscopy

    Time frame: Month 12

Secondary outcomes

  1. Partial resolution of NAFLD

    Time frame: Month 12

  2. Visceral fat measurement

    Time frame: Month 12

  3. Liver fibrosis by transient elastography

    Time frame: Month 12

  4. Metabolic endpoints

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2009
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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