Fatty Liver
Conditions
Keywords
NAFLD, NASH
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.
Interventions
BEHAVIORALMod Fat/Low Processed Carb Diet and Moderate Exercise
Follow a moderate fat with low processed carbohydrate diet with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
BEHAVIORALLow Fat Diet and Moderate Exercise
Follow a low fat diet along with moderate exercise at the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
BEHAVIORALModerate Exercise Only
No special dietary meal plan. Moderate exercise in the cardiac rehab clinic (2x/wk for 8 wks, 1x/wk for 8 wks, 1x/2wks for 8 wks)
Sponsors
San Antonio Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Insulin resistance (IR) | 6 months |
Countries
United States
Outcome results
None listed