Overview

This trial is active, not recruiting.

Conditions metabolic syndrome, non-alcoholic fatty liver disease, obesity
Treatments low-fat diet, low-carbohydrate diet
Sponsor University of Texas Southwestern Medical Center
Start date September 2007
End date June 2012
Trial size 24 participants
Trial identifier NCT01371396, 5RL-1DK081187

Summary

The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking open label
Primary purpose basic science
Arm
(Other)
Subjects will identify as Hispanic ethnicity.
low-fat diet
The subject will consume a diet that is calorically restricted to cause at least a 6% body weight loss over 4 months. Fat will make up less than 30% of dietary energy.
low-carbohydrate diet
The diet will be restricted in energy to cause at least a 6% loss of body weight over a 4 month period. Carbohydrate will provide less than 40% of total dietary energy.
(Other)
Subjects will self-identify as African American in origin.
low-fat diet
The subject will consume a diet that is calorically restricted to cause at least a 6% body weight loss over 4 months. Fat will make up less than 30% of dietary energy.
low-carbohydrate diet
The diet will be restricted in energy to cause at least a 6% loss of body weight over a 4 month period. Carbohydrate will provide less than 40% of total dietary energy.

Primary Outcomes

Measure
de novo lipogenesis
time frame: Change from Baseline in fatty acid synthesis at 5 months

Secondary Outcomes

Measure
Dietary fatty acid clearance to liver
time frame: Change from Baseline in dietary fat clearance at 5 months
Adipose fatty acid flux
time frame: Change from Baseline in adipose fat flux at 5 months

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria: - Elevated serum ALT or metabolic syndrome - African American or Hispanic - Nondiabetic - Men or women - Smokers and nonsmokers - Pre- and post-menopausal (+/- HRT) - Stable body weight - Age 20-65 years - BMI between 25-45 kg/m2 Exclusion Criteria: - Diabetes or Pregnancy - Ethanol intake: males > 140 g/week, females > 70 g/week - Chronic hepatitis B or chronic hepatitis C - Hemochromatosis or Wilson's Disease - Autoimmune hepatitis or primary biliary cirrhosis

Additional Information

Official title Effect of Dietary Macronutrient Composition on Liver Substrate Metabolism
Principal investigator Elizabeth J Parks, PhD
Description Obesity is a major factor driving the increased prevalence of hepatic steatosis in the US. However, little is known regarding the relationship between dietary intake and hepatic fat deposition or about the factors that promote loss of hepatic steatosis. Here, the investigators will determine how differences in dietary composition affect the development and regression of fatty liver. The investigators hypothesize that Hispanic subjects with metabolic syndrome will have higher liver fat synthesis rates compared to African American subjects. Using detailed in vivo, serial measurements of fuel metabolism (GC/MS and NMR) fatty acid metabolism will be measured in the liver and periphery. This will be the first study in which these two methodologies are used together to assess both glucose and fatty acid metabolism in the same subjects. Subjects will be tested before and after a dietary weight-loss intervention producing 6% body weight loss over 5 months. The specific aims are as follows: AIM 1: Determine the contribution of peripheral and dietary fat to liver-TG in Hispanics and African Americans with metabolic syndrome. Hypothesis: De novo lipogenesis will contribute to liver-TG in greater quantities compared to African Americans. AIM 2: Determine the effects of low-CHO and low-fat diets on liver fat regression. Hypothesis: Compared to a low-fat diet, a low-CHO diet will markedly decrease markers of inflammation coincident with greater improvements in insulin sensitivity as assessed by an intravenous glucose tolerance test.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.