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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Renee E. Cole, San Antonio Military Medical Center
ClinicalTrials.gov Identifier:
NCT00815009
First received: December 24, 2008
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Fatty Liver
 Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise
Behavioral: Low Fat Diet and Moderate Exercise
Behavioral: Moderate Exercise Only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by San Antonio Military Medical Center:

Primary Outcome Measures:
  • NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance (IR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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).
 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)
Other Name: Low Carb / Mod Fat
Experimental: B (Low Fat)
Standard of Care, plus Low Fat Diet and Moderate Exercise
 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)
Other Name: Low Carb / Mod Fat
Behavioral: 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)
Other Name: Low Fat
Experimental: C (Mod Fat)
Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise
 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)
Other Name: Low Carb / Mod Fat
Experimental: D (Exercise only)
Standard of Care plus Moderate Exercise only
 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)
Other Name: Low Carb / Mod Fat
Behavioral: 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)
Other Name: Mod exercise

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815009

Locations
United States, Texas
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
San Antonio Military Medical Center
Investigators
Principal Investigator: Renee E Cole, MS, PhD San Antonio Military Medical Center
  More Information

No publications provided

Responsible Party: Renee E. Cole, Director, US Military Dietetic Internship Consortium, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT00815009     History of Changes
Other Study ID Numbers: C.2008.171
Study First Received: December 24, 2008
Last Updated: July 13, 2012
Health Authority: United States: Federal Government

Keywords provided by San Antonio Military Medical Center:
NAFLD
NASH

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 13, 2013