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

Fatty Liver Clinical Trial

— NAFLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815009
• Other study ID #: C.2008.171
• Status: Completed
• Phase: N/A
• First received: December 24, 2008
• Last updated: July 13, 2012
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: San Antonio Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases

Intervention

Behavioral:
• Mod Fat/Low Processed Carb Diet and Moderate Exercise
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 Exercise
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
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)

Locations

Country	Name	City	State
United States	San Antonio Military Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
San Antonio Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)		6 months	No
Secondary	Insulin resistance (IR)		6 months	No