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Completed

NCT Number: NCT01371396

Effect of Dietary Macronutrient Composition

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

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Key information

Conditions

Metabolic Syndrome Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Non-Alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Human Nutrition

Dallas, Texas, 75390-9052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Low-Fat Diet

Other

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

Other

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

  1. de novo lipogenesis

    Time frame: Change from Baseline in fatty acid synthesis at 5 months

    In vivo measurement is made of liver fatty acid synthesis using stable isotope administration and analysis of plasma samples by GS/MS

Secondary outcomes

  1. Dietary fatty acid clearance to liver

    Time frame: Change from Baseline in dietary fat clearance at 5 months

    Using a dietary stable isotope we will quantitate fat absorption and recycling of fat through the liver.

  2. Adipose fatty acid flux

    Time frame: Change from Baseline in adipose fat flux at 5 months

    A stable isotope is infused and the rate of adipose fatty acid release is calculated after analyzing blood samples.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Effect of Dietary Macronutrient Composition on Liver Substrate Metabolism

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2011
Registry last updated
Feb 6, 2019

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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