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

Not Applicable

Completed

• Conditions: Fatty Liver
• Interventions: Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise; Behavioral: Low Fat Diet and Moderate Exercise; Behavioral: Moderate Exercise Only

• Registration Number: NCT00815009
• Lead Sponsor: San Antonio Military Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-24
• Study First Submitted QC: 2008-12-24
• Study First Posted: 2008-12-29
• Primary Completion: 2010-03
• Study Completion: 2010-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-13
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (Std of Care)	Mod Fat/Low Processed Carb Diet and Moderate Exercise	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)	Mod Fat/Low Processed Carb Diet and Moderate Exercise	Standard of Care, plus Low Fat Diet and Moderate Exercise
B (Low Fat)	Low Fat Diet and Moderate Exercise	Standard of Care, plus Low Fat Diet and Moderate Exercise
C (Mod Fat)	Mod Fat/Low Processed Carb Diet and Moderate Exercise	Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise
D (Exercise only)	Mod Fat/Low Processed Carb Diet and Moderate Exercise	Standard of Care plus Moderate Exercise only
D (Exercise only)	Moderate Exercise Only	Standard of Care plus Moderate Exercise only

Primary Outcome Measures

Name	Time	Method
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)	6 months

Secondary Outcome Measures

Name	Time	Method
Insulin resistance (IR)	6 months

Trial Locations

Locations (1)

San Antonio Military Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States