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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Nonalcoholic Fatty Liver Disease

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Resolution of NAFLD by proton-magnetic resonance spectroscopy

Outcome Time Frame:

Month 12

Safety Issue:

No

Authority:

Hong Kong: Department of Health

Study ID:

NAFLD-Diet

NCT ID:

NCT00868933

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Nonalcoholic Fatty Liver Disease
  • Fatty Liver
  • Liver Diseases

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