Effect of Diet Composition on Liver Fat and Glucose Metabolism

NCT ID: NCT00930371

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-09-30

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.

Conditions

Fatty Liver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Interventions

high fat/high saturated fat diet

4 weeks 55% fat/25% saturated fat isocaloric diet

Intervention Type: OTHER

low fat/low saturated fat diet

4 weeks 20% fat/8% saturated fat isocaloric diet

Intervention Type: OTHER

Other Intervention Names

Diet; Diet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Puget Sound Health Care System

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kristina Utzschneider

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristina M Utzschneider, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System/University of Washington

Locations

University of Washington

Seattle, Washington, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25353663 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26615402 (View on PubMed)

Other Identifiers

35016-D

Identifier Type: -

Identifier Source: org_study_id