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Effect of Diet Composition on Liver Fat and Glucose Metabolism (DietLFAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930371
First Posted: June 30, 2009
Last Update Posted: December 3, 2015
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.
Collaborator:
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Kristina Utzschneider, University of Washington
June 26, 2009
June 30, 2009
December 3, 2015
June 2009
September 2012   (Final data collection date for primary outcome measure)
hepatic triglyceride content by MRS [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00930371 on ClinicalTrials.gov Archive Site
  • insulin sensitivity [ Time Frame: 4 weeks ]
  • systemic and subcutaneous adipose tissue inflammation [ Time Frame: 4 weeks ]
  • oxidative stress markers [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
Effect of Diet Composition on Liver Fat and Glucose Metabolism
Effect of Diet Composition on Liver Fat and Glucose Metabolism
This study is designed to determine if the amount of fat and saturated fat in the diet contributes to the development of a condition called fatty liver disease in the absence of changes in weight.
A condition called non-alcoholic steatohepatitis is characterized by fat accumulation in the liver and associated inflammation. This condition is strongly associated with obesity, insulin resistance and type 2 diabetes. Diets high in saturated fat result in fatty liver, insulin resistance and liver injury in animal models. Dietary composition may contribute not only to hepatic fat accumulation and insulin resistance but may also promote inflammation leading to chronic liver disease in humans. This study will test the hypothesis that a diet high in fat and saturated fat contributes to liver fat accumulation, insulin resistance and inflammation by comparing the effects of a four-week, weight stable high fat/high saturated fat diet (55% calories from fat/25% saturated fat) with a four-week, weight stable low fat/low saturated fat diet (20% fat/8% saturated fat) in overweight and obese subjects.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Fatty Liver
  • Other: high fat/high saturated fat diet
    4 weeks 55% fat/25% saturated fat isocaloric diet
    Other Name: Diet
  • Other: low fat/low saturated fat diet
    4 weeks 20% fat/8% saturated fat isocaloric diet
    Other Name: Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-55 years old, men and women, otherwise in good general health, BMI >27 kg/m2

Exclusion Criteria:

  • Abnormal glucose tolerance, fasting glucose>100 mg/dl or diabetes
  • History of liver condition or alanine aminotransferase (ALT) above the upper limit of the normal range
  • Use of medications that cause insulin resistance or fatty liver: niacin, glucocorticoids, estrogens, tamoxifen, amiodarone, accutane, sertraline, atypical antipsychotics, anti-HIV medications
  • Chronic use of anti-inflammatory medications (aspirin, ibuprofen, naprosyn, steroids, etc)
  • Average alcohol intake >20 grams/day
  • Tobacco use
  • Creatinine >1.5 mg/dl for men and >1.4 mg/dl for women
  • Hematocrit <33%
  • Pregnancy or lactation
  • Significant weight loss within the past 6 months (>5% body weight)
  • Claustrophobia or any contraindications to being placed in the magnet for the MRS scan such as pacemakers, defibrillators, brain aneurysm clips, etc.
  • Other serious medical conditions or inflammatory conditions such as cancer, inflammatory arthritis, etc.
  • History of multiple food allergies or intolerances or severe food allergies
  • History of coronary artery disease, history of or treatment of hyperlipidemia, LDL >200 mg/dl, fasting triglycerides >300 mg/dl
  • Weight >300 pounds
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00930371
35016-D
No
Not Provided
Not Provided
Kristina Utzschneider, University of Washington
University of Washington
VA Puget Sound Health Care System
Principal Investigator: Kristina M Utzschneider, MD VA Puget Sound Health Care System/University of Washington
University of Washington
December 2015

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