Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

February 20, 2014 updated by: Henry LY Chan, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 24, 2009

First Posted (Estimate)

March 25, 2009

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFLD-Diet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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