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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
VA Puget Sound Health Care System
Information provided by (Responsible Party):
Kristina Utzschneider, University of Washington
ClinicalTrials.gov Identifier:
NCT00930371
First received: June 26, 2009
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Fatty Liver
Other: high fat/high saturated fat diet
Other: low fat/low saturated fat diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Diet Composition on Liver Fat and Glucose Metabolism

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • hepatic triglyceride content by MRS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin sensitivity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • systemic and subcutaneous adipose tissue inflammation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • oxidative stress markers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930371

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98108
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
VA Puget Sound Health Care System
Investigators
Principal Investigator: Kristina M Utzschneider, MD VA Puget Sound Health Care System/University of Washington
  More Information

No publications provided

Responsible Party: Kristina Utzschneider, Associate Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00930371     History of Changes
Other Study ID Numbers: 35016-D
Study First Received: June 26, 2009
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
fatty liver
insulin resistance
diet
inflammation
oxidative stress

Additional relevant MeSH terms:
Fatty Liver
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 22, 2014