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

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.

Study Overview

• Status: Completed
• Conditions: Fatty Liver
• Intervention / Treatment: Other: high fat/high saturated fat diet; Other: low fat/low saturated fat 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • University of Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hepatic triglyceride content by MRS	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
insulin sensitivity	4 weeks
systemic and subcutaneous adipose tissue inflammation	4 weeks
oxidative stress markers	4 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: VA Puget Sound Health Care System
• Investigators: Principal Investigator: Kristina M Utzschneider, MD, VA Puget Sound Health Care System/University of Washington

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 26, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: inflammation; insulin resistance; diet; fatty liver; oxidative stress
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: 35016-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No