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

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:
  • Low Carb / Mod Fat
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:
  • Low Carb / Mod Fat
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:
  • Low Fat
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:
  • Low Carb / Mod Fat
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:
  • Low Carb / Mod Fat
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:
  • Mod exercise

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

Keywords

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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