Clinical trial NCT00930371: Effect of Diet Composition on Liver Fat and Glucose Metabolism
Official title: Effect of Diet Composition on Liver Fat and Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Keywords: fatty liver
insulin resistance
diet
inflammation
oxidative stress
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: VA Puget Sound Health Care System
First posted: 2009-06-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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

Primary outcomes:
measure: hepatic triglyceride content by MRS
timeFrame: 4 weeks
Secondary outcomes:
measure: insulin sensitivity
timeFrame: 4 weeks
measure: systemic and subcutaneous adipose tissue inflammation
timeFrame: 4 weeks
measure: oxidative stress markers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System/University of Washington
name: Kristina M Utzschneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marina A, von Frankenberg AD, Suvag S, Callahan HS, Kratz M, Richards TL, Utzschneider KM. Effects of dietary fat and saturated fat content on liver fat and markers of oxidative stress in overweight/obese men and women under weight-stable conditions. Nutrients. 2014 Oct 28;6(11):4678-90. doi: 10.3390/nu6114678.
citation: von Frankenberg AD, Marina A, Song X, Callahan HS, Kratz M, Utzschneider KM. A high-fat, high-saturated fat diet decreases insulin sensitivity without changing intra-abdominal fat in weight-stable overweight and obese adults. Eur J Nutr. 2017 Feb;56(1):431-443. doi: 10.1007/s00394-015-1108-6. Epub 2015 Nov 28.