NCT00930371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

June 26, 2009

Last Update Submit

December 1, 2015

Conditions

Fatty Liver

Keywords

fatty liverinsulin resistancedietinflammationoxidative stress

Outcome Measures

Primary Outcomes (1)

  • hepatic triglyceride content by MRS

    4 weeks

Secondary Outcomes (3)

  • insulin sensitivity

    4 weeks

  • systemic and subcutaneous adipose tissue inflammation

    4 weeks

  • oxidative stress markers

    4 weeks

Interventions

high fat/high saturated fat dietOTHER

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

Also known as: Diet
low fat/low saturated fat dietOTHER

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

Also known as: Diet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55 years old, men and women, otherwise in good general health, BMI \>27 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Washington

Seattle, Washington, 98108, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related 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. Nutrients. 2014 Oct 28;6(11):4678-90. doi: 10.3390/nu6114678.

    PMID: 25353663RESULT

  • 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.

    PMID: 26615402RESULT

MeSH Terms

Conditions

Fatty LiverInsulin ResistanceInflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kristina M Utzschneider, MD

    VA Puget Sound Health Care System/University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 30, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(2)