Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry LY Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00868933
First received: March 24, 2009
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Nonalcoholic Fatty Liver Disease
Other: Low glycemic index dietary intervention program
Other: simple lifestyle advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Resolution of NAFLD by proton-magnetic resonance spectroscopy [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial resolution of NAFLD [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Visceral fat measurement [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Liver fibrosis by transient elastography [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Metabolic endpoints [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low glycemic index dietary intervention program
The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.
Other: Low glycemic index dietary intervention program
The intervention group involves dietary advice and monitoring. No drug or invasive procedure is involved.
Placebo Comparator: Simple lifestyle advice
The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.
Other: simple lifestyle advice
The control group receives lifestyle advice from a clinician, and the clinical care is not inferior to current practice.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868933

Locations
China
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henry LY Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00868933     History of Changes
Other Study ID Numbers: NAFLD-Diet
Study First Received: March 24, 2009
Last Updated: February 20, 2014
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014