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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Liver Diseases
Fatty Liver
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014