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Low Glycemic Index Dietary Intervention Program in Nonalcoholic Fatty Liver Disease

NCT00868933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2014-02-24

No results posted yet for this study

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.

Conditions

  • Nonalcoholic Fatty Liver Disease

Interventions

OTHER

Low glycemic index dietary intervention program

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

OTHER

simple lifestyle advice

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868933 on ClinicalTrials.gov