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

Primary Purpose

Fatty Liver

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mod Fat/Low Processed Carb Diet and Moderate Exercise

Low Fat Diet and Moderate Exercise

Moderate Exercise Only

About this trial

This is an interventional treatment trial for Fatty Liver focused on measuring NAFLD, NASH

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Antonio Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

A (Std of Care)

B (Low Fat)

C (Mod Fat)

D (Exercise only)

Arm Description

Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD).

Standard of Care, plus Low Fat Diet and Moderate Exercise

Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise

Standard of Care plus Moderate Exercise only

Outcomes

Primary Outcome Measures

NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)

Secondary Outcome Measures

Insulin resistance (IR)

Full Information

NCT ID

NCT00815009

First Posted

December 24, 2008

Last Updated

July 13, 2012

Sponsor

San Antonio Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00815009

Brief Title

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

Acronym

NAFLD

Official Title

Prospective Histopathologic Evaluation of Diet and Exercise in Patients With Non-Alcoholic Fatty Liver Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

San Antonio Military Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver

Keywords

NAFLD, NASH

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A (Std of Care)

Arm Type

No Intervention

Arm Description

Standard of Care/Control, including Lifestyle Advice (attend a basic healthy nutrition class as well as follow up appointments with GI MD).

Arm Title

B (Low Fat)

Arm Type

Experimental

Arm Description

Standard of Care, plus Low Fat Diet and Moderate Exercise

Arm Title

C (Mod Fat)

Arm Type

Experimental

Arm Description

Standard of Care, plus Moderate Fat/Low Processed Carbohydrate Diet and Moderate Exercise

Arm Title

D (Exercise only)

Arm Type

Experimental

Arm Description

Standard of Care plus Moderate Exercise only

Intervention Type

Behavioral

Intervention Name(s)

Mod Fat/Low Processed Carb Diet and Moderate Exercise

Other Intervention Name(s)

Low Carb / Mod Fat

Intervention Description

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)

Intervention Type

Behavioral

Intervention Name(s)

Low Fat Diet and Moderate Exercise

Other Intervention Name(s)

Low Fat

Intervention Description

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)

Intervention Type

Behavioral

Intervention Name(s)

Moderate Exercise Only

Other Intervention Name(s)

Mod exercise

Intervention Description

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)

Primary Outcome Measure Information:

Title

NAFLD Activity Score (Percent liver steatosis, inflammation, and fibrosis)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Insulin resistance (IR)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renee E Cole, MS, PhD

Organizational Affiliation

San Antonio Military Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Antonio Military Medical Center

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

12. IPD Sharing Statement

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

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