Effect of Diet Composition on Liver Fat and Glucose Metabolism

Fatty Liver Clinical Trial

— DietLFAT  

Official title:

Effect of Diet Composition on Liver Fat and Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930371
• Other study ID #: 35016-D
• Status: Completed
• Phase: N/A
• First received: June 26, 2009
• Last updated: December 1, 2015
• Start date: June 2009
• Est. completion date: September 2012

Study information

• Verified date: December 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatty Liver

Intervention

Other:
• high fat/high saturated fat diet
4 weeks 55% fat/25% saturated fat isocaloric diet
• low fat/low saturated fat diet
4 weeks 20% fat/8% saturated fat isocaloric diet

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Nutr — View 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. 2015 Nov 28. [Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatic triglyceride content by MRS		4 weeks	No
Secondary	insulin sensitivity		4 weeks	No
Secondary	systemic and subcutaneous adipose tissue inflammation		4 weeks	No
Secondary	oxidative stress markers		4 weeks	No