Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
NAFLD
Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 24, 2008
CompletedFirst Posted
Study publicly available on registry
December 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 16, 2012
July 1, 2012
1.4 years
December 24, 2008
July 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
6 months
Secondary Outcomes (1)
Insulin resistance (IR)
6 months
Study Arms (4)
A (Std of Care)
NO INTERVENTIONStandard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD).
B (Low Fat)
EXPERIMENTALStandard of Care, plus Low Fat Diet and Moderate Exercise
C (Mod Fat)
EXPERIMENTALStandard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise
D (Exercise only)
EXPERIMENTALStandard of Care plus Moderate Exercise only
Interventions
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)
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)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renee E Cole, MS, PhD
San Antonio Military Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, US Military Dietetic Internship Consortium
Study Record Dates
First Submitted
December 24, 2008
First Posted
December 29, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2010
Study Completion
December 1, 2010
Last Updated
July 16, 2012
Record last verified: 2012-07