Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease

Conditions
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Fatty Liver

Intervention / Treatment
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* Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise
* Behavioral: Low Fat Diet and Moderate Exercise
* Behavioral: Moderate Exercise Only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A (Std of Care)<br>Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD). | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise<br>* 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)<br>* Other names: Low Carb / Mod Fat;|
| Experimental: B (Low Fat)<br>Standard of Care, plus Low Fat Diet and Moderate Exercise | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise<br>* 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)<br>* Other names: Low Carb / Mod Fat;Behavioral: Low Fat Diet and Moderate Exercise<br>* 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)<br>* Other names: Low Fat;|
| Experimental: C (Mod Fat)<br>Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise<br>* 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)<br>* Other names: Low Carb / Mod Fat;|
| Experimental: D (Exercise only)<br>Standard of Care plus Moderate Exercise only | Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise<br>* 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)<br>* Other names: Low Carb / Mod Fat;Behavioral: Moderate Exercise Only<br>* 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)<br>* Other names: Mod exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance (IR) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, NASH