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

San Antonio Military Medical Center56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fatty Liver

Interventions

Mod Fat/Low Processed Carb Diet and Moderate ExerciseBEHAVIORAL

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)

Low Fat Diet and Moderate ExerciseBEHAVIORAL

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 OnlyBEHAVIORAL

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

San Antonio Military Medical Center

Fort Sam Houston, Texas, United States

Outcomes

Primary Outcomes

NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)

Time frame: 6 months

Secondary Outcomes

Insulin resistance (IR)

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.