- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00815009
Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
July 13, 2012 updated by: Renee E. Cole, San Antonio Military Medical Center
Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- San Antonio Military Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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 Names:
|
Experimental: B (Low Fat)
Standard of Care, plus Low Fat 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 Names:
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 Names:
|
Experimental: C (Mod Fat)
Standard of Care, plus Moderate Fat/Low Processed Carbohydrate 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 Names:
|
Experimental: D (Exercise only)
Standard of Care plus Moderate Exercise only
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin resistance (IR)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Renee E Cole, MS, PhD, San Antonio Military Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 24, 2008
First Submitted That Met QC Criteria
December 24, 2008
First Posted (Estimate)
December 29, 2008
Study Record Updates
Last Update Posted (Estimate)
July 16, 2012
Last Update Submitted That Met QC Criteria
July 13, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.2008.171
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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