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Completed

NCT Number: NCT00815009

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.

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Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mod Fat/Low Processed Carb Diet and Moderate Exercise

Behavioral

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

Low Fat Diet and Moderate Exercise

Behavioral

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

Moderate Exercise Only

Behavioral

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

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Insulin resistance (IR)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

San Antonio Military Medical Center

Fed

Registry information

Official study title

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

Acronym: NAFLD

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 29, 2008
Registry last updated
Jul 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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