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CompletedNCT00930371DietLFATUpdated Dec 3, 2015

Effect of Diet Composition on Liver Fat and Glucose Metabolism

An interventional study of high fat/high saturated fat diet and low fat/low saturated fat diet in Fatty Liver, sponsored by University of Washington. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by University of Washington · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fatty Liver

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Keywords

  • fatty liver
  • insulin resistance
  • diet
  • inflammation
  • oxidative stress
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 16 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
16 participants (actual)

Interventions

  • Otherhigh fat/high saturated fat diet

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

    Also known as: Diet

  • Otherlow fat/low saturated fat diet

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

    Also known as: Diet

06

What researchers measure

Primary outcomes

  1. hepatic triglyceride content by MRS

    Time frame: 4 weeks

Secondary outcomes

  1. insulin sensitivity

    Time frame: 4 weeks

  2. systemic and subcutaneous adipose tissue inflammation

    Time frame: 4 weeks

  3. oxidative stress markers

    Time frame: 4 weeks

07

Study locations

2 sites
  • University of Washington
    Seattle, Washington 98108, United States
  • VA Puget Sound Health Care System
    Seattle, Washington 98108, United States
08

References and documents

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. PubMed 25353663 ↗
  • 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. PubMed 26615402 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00930371
Lead sponsor
University of Washington
Collaborators
VA Puget Sound Health Care System
Responsible party
Kristina Utzschneider (Associate Professor of Medicine, University of Washington) — Principal investigator
First posted
Jun 30, 2009
Start date
Jun 2009
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Dec 3, 2015

Study contacts

Kristina M Utzschneider, MD
principal investigator · VA Puget Sound Health Care System/University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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