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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815009
First Posted: December 29, 2008
Last Update Posted: July 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Renee E. Cole, San Antonio Military Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Renee E. Cole, San Antonio Military Medical Center:

Primary Outcome Measures:
  • NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Insulin resistance (IR) [ Time Frame: 6 months ]

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 24, 2008
First Posted: December 29, 2008
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by Renee E. Cole, San Antonio Military Medical Center:
NAFLD
NASH

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases