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

San Antonio Military Medical Center

Status: Completed

Conditions: Fatty Liver

Treatments: Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise; Behavioral: Low Fat Diet and Moderate Exercise; Behavioral: Moderate Exercise Only

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00815009

C.2008.171

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 4 patient groups

A (Std of Care)

No Intervention group

Description:

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

Treatment:

Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise

B (Low Fat)

Experimental group

Description:

Standard of Care, plus Low Fat Diet and Moderate Exercise

Treatment:

Behavioral: Low Fat Diet and Moderate Exercise

Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise

C (Mod Fat)

Experimental group

Description:

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

Treatment:

Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise

D (Exercise only)

Experimental group

Description:

Standard of Care plus Moderate Exercise only

Treatment:

Behavioral: Moderate Exercise Only

Behavioral: Mod Fat/Low Processed Carb Diet and Moderate Exercise