This trial is active, not recruiting.

Condition fatty liver
Treatments high fat/high saturated fat diet, low fat/low saturated fat diet
Sponsor University of Washington
Collaborator VA Puget Sound Health Care System
Start date June 2009
End date June 2014
Trial size 16 participants
Trial identifier NCT00930371, 35016-D


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking single blind (subject)
Primary purpose basic science

Primary Outcomes

hepatic triglyceride content by MRS
time frame: 4 weeks

Secondary Outcomes

insulin sensitivity
time frame: 4 weeks
systemic and subcutaneous adipose tissue inflammation
time frame: 4 weeks
oxidative stress markers
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Effect of Diet Composition on Liver Fat and Glucose Metabolism
Principal investigator Kristina M Utzschneider, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University of Washington.