Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
Not Applicable
Completed
- Conditions
- Fatty Liver
- Registration Number
- NCT00815009
- Lead Sponsor
- San Antonio Military Medical Center
- Brief Summary
Moderate exercise with a low fat and/or a moderate fat with low processed carbohydrate diet will have a greater effect on slowing disease progression and reversing hepatic steatosis and/or necro-inflammation in the liver of adult patients with NAFLD and NASH when compared to a regular healthy diet alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Age 18-70 yrs
- DEERS eligible (DoD beneficiary)
- All participants must plan to be in the area for at least nine months
- Liver biopsy confirmed NAFLD/NASH (NAS Score evaluating steatosis, lobular inflammation and hepatocyte ballooning) within the past 6 months
Exclusion Criteria
- Alcohol consumption > 20 g/d or history of alcohol abuse
- Hepatitis A, B, C
- Chronic liver disease of any other etiology
- Fatty acid oxidation disorder (Inborn errors of metabolism)
- Insulin therapy regime for treatment of diabetes
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis) 6 months
- Secondary Outcome Measures
Name Time Method Insulin resistance (IR) 6 months
Trial Locations
- Locations (1)
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
San Antonio Military Medical Center🇺🇸Fort Sam Houston, Texas, United States