Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
A (Std of Care)
Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD).
Intervention: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
B (Low Fat)
Standard of Care, plus Low Fat Diet and Moderate Exercise
Intervention: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
B (Low Fat)
Standard of Care, plus Low Fat Diet and Moderate Exercise
Intervention: Low Fat Diet and Moderate Exercise (Behavioral)
C (Mod Fat)
Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise
Intervention: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
D (Exercise only)
Standard of Care plus Moderate Exercise only
Intervention: Mod Fat/Low Processed Carb Diet and Moderate Exercise (Behavioral)
D (Exercise only)
Standard of Care plus Moderate Exercise only
Intervention: Moderate Exercise Only (Behavioral)
Outcomes
Primary Outcomes
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
Time Frame: 6 months
Secondary Outcomes
- Insulin resistance (IR)(6 months)
Investigators
Renee E. Cole
Director, US Military Dietetic Internship Consortium
San Antonio Military Medical Center