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Effect of Dietary Macronutrient Composition

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Elizabeth Parks, University of Texas Southwestern Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371396
First Posted: June 10, 2011
Last Update Posted: April 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth Parks, University of Texas Southwestern Medical Center
June 7, 2011
June 10, 2011
April 23, 2012
September 2007
June 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01371396 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Effect of Dietary Macronutrient Composition
Effect of Dietary Macronutrient Composition on Liver Substrate Metabolism
The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Metabolic Syndrome
  • Non-alcoholic Fatty Liver Disease
  • Obesity
  • Other: 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.
  • Other: 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.
  • Hispanic subjects
    Subjects will identify as Hispanic ethnicity.
    Interventions:
    • Other: Low-fat diet
    • Other: Low-carbohydrate diet
  • African American subjects
    Subjects will self-identify as African American in origin.
    Interventions:
    • Other: Low-fat diet
    • Other: Low-carbohydrate diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
June 2014
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01371396
5RL-1DK081187
Yes
Not Provided
Not Provided
Elizabeth Parks, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Elizabeth J Parks, PhD UTSW Medical Center
University of Texas Southwestern Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP