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Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT00868933
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
Henry LY Chan, 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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Other: Low glycemic index dietary intervention program Other: simple lifestyle advice Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease - A Randomized Controlled Trial
Study Start Date : February 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Resolution of NAFLD by proton-magnetic resonance spectroscopy [ Time Frame: Month 12 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

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
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases