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

NCT00815009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2012-07-16

No results posted yet for this study

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.

Conditions

Interventions

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)

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)

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)

Sponsors & Collaborators

  • San Antonio Military Medical Center

    lead FED

Principal Investigators

  • Renee E Cole, MS, PhD · San Antonio Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-03-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815009 on ClinicalTrials.gov