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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Std of Care) | No Intervention | Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD). |
|
| B (Low Fat) | Experimental | Standard of Care, plus Low Fat Diet and Moderate Exercise |
|
| C (Mod Fat) | Experimental | Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise |
|
| D (Exercise only) | Experimental | Standard of Care plus Moderate Exercise only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mod Fat/Low Processed Carb Diet and Moderate Exercise | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance (IR) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee E Cole, MS, PhD | San Antonio Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78234 | United States |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| Low Fat Diet and Moderate Exercise | Behavioral | 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) |
|
|
| Moderate Exercise Only | Behavioral | 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) |
|
|
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |