Fatty LiverDietLFATNCT00930371
Effect of Diet Composition on Liver Fat and Glucose Metabolism
A study testing high fat/high saturated fat diet and low fat/low saturated fat diet in people with Fatty Liver, run by University of Washington at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Liver
- What is being tested?
- high fat/high saturated fat diet and low fat/low saturated fat diet
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55 years old, men and women, otherwise in good general health, BMI >27 kg/m2
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington
Seattle, Washington, 98108
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
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.
- Conditions
- Fatty Liver
- Being tested
- high fat/high saturated fat diet, low fat/low saturated fat diet
- Keywords
- fatty liver, insulin resistance, diet, inflammation, oxidative stress
- Medical subject headings
- Fatty Liver, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high fat/high saturated fat dietOther
Also called Diet
4 weeks 55% fat/25% saturated fat isocaloric diet
low fat/low saturated fat dietOther
Also called Diet
4 weeks 20% fat/8% saturated fat isocaloric diet
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic triglyceride content by MRS
Measured: 4 weeks
Secondary outcomes (3)
insulin sensitivity
Measured: 4 weeks
systemic and subcutaneous adipose tissue inflammation
Measured: 4 weeks
oxidative stress markers
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System
- Responsible party
- Principal investigator, Kristina Utzschneider, University of Washington
- Investigators
- Kristina M Utzschneider, MD, Principal investigator, VA Puget Sound Health Care System/University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930371
- Sponsor's protocol ID
- 35016-D
- Acronym
- DietLFAT
- Status last verified
- Dec 2015
- First submitted
- 26 Jun 2009
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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 25353663von 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet Composition on Liver Fat and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT00930371
- Acronym / sponsor ID
- DietLFAT / 35016-D
- Conditions
- Fatty Liver
- Keywords
- fatty liver, insulin resistance, diet, inflammation, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System
- Study start
- Jun 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-55 years old, men and women, otherwise in good general health, BMI >27 kg/m2
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high fat/high saturated fat dietAlso: Diet4 weeks 55% fat/25% saturated fat isocaloric diet | Other | – |
| low fat/low saturated fat dietAlso: Diet4 weeks 20% fat/8% saturated fat isocaloric diet | Other | – |
Primary outcome
hepatic triglyceride content by MRS
Time frame: 4 weeks
3 secondary outcomes
insulin sensitivity
Time frame: 4 weeks
systemic and subcutaneous adipose tissue inflammation
Time frame: 4 weeks
oxidative stress markers
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Results publication: PubMed 25353663Marina 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 publication: PubMed 26615402von 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina M Utzschneider, MD principal investigator
VA Puget Sound Health Care System/University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fat/high saturated fat diet and low fat/low saturated fat diet in people with Fatty Liver, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatic triglyceride content by MRS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00930371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.