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

Primary Purpose

Fatty Liver

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high fat/high saturated fat diet
low fat/low saturated fat diet
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatty Liver focused on measuring fatty liver, insulin resistance, diet, inflammation, oxidative stress

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington
  • VA Puget Sound Health Care System

Outcomes

Primary Outcome Measures

hepatic triglyceride content by MRS

Secondary Outcome Measures

insulin sensitivity
systemic and subcutaneous adipose tissue inflammation
oxidative stress markers

Full Information

First Posted
June 26, 2009
Last Updated
December 1, 2015
Sponsor
University of Washington
Collaborators
VA Puget Sound Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT00930371
Brief Title
Effect of Diet Composition on Liver Fat and Glucose Metabolism
Acronym
DietLFAT
Official Title
Effect of Diet Composition on Liver Fat and Glucose Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
VA Puget Sound Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
Keywords
fatty liver, insulin resistance, diet, inflammation, oxidative stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
high fat/high saturated fat diet
Other Intervention Name(s)
Diet
Intervention Description
4 weeks 55% fat/25% saturated fat isocaloric diet
Intervention Type
Other
Intervention Name(s)
low fat/low saturated fat diet
Other Intervention Name(s)
Diet
Intervention Description
4 weeks 20% fat/8% saturated fat isocaloric diet
Primary Outcome Measure Information:
Title
hepatic triglyceride content by MRS
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
4 weeks
Title
systemic and subcutaneous adipose tissue inflammation
Time Frame
4 weeks
Title
oxidative stress markers
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina M Utzschneider, MD
Organizational Affiliation
VA Puget Sound Health Care System/University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25353663
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.
Results Reference
result
PubMed Identifier
26615402
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.
Results Reference
result

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Effect of Diet Composition on Liver Fat and Glucose Metabolism

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