Effect of Omega-3 PUFA Supplementation in NAFLD Patients - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00230113

Purpose

The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids will decrease the amount of fat in liver.

Condition	Intervention	Phase
Non-Alcoholic Fatty Liver Disease	Dietary Supplement: Omega-3 fatty acid diet supplementation Dietary Supplement: safflower oil	Phase II

MedlinePlus related topics: Dietary Supplements Diets Liver Diseases

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Safflower oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Masked, Controlled Study of Omega-3 Polyunsaturated Fatty Acid vs Monounsaturated Fatty Acid Diet Supplementation for the Treatment of Nonalcoholic Fatty Liver Disease

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy [ Time Frame: 2 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in serum aminotransferase levels Change in lipid profile Change in levels of proinflammatory cytokines [ Time Frame: 2 month ] [ Designated as safety issue: No ]
Change in insulin resistance determined by HOMA [ Time Frame: 2 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2005
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Dietary Supplement: Omega-3 fatty acid diet supplementation 4 gm fish oil per day
2: Placebo Comparator	Dietary Supplement: safflower oil 4 gm per day safflower oil

Detailed Description:

NAFLD is the most common liver disease in the United States and is also a common cause of abnormal liver tests in the United States. NAFLD includes mild as well as a more severe nonalcoholic fatty liver disease involving liver cell inflammation and damage, called Nonalcoholic Steatohepatitis (NASH). NAFLD is usually discovered because of abnormal liver tests or from a liver ultrasound or CT scan in persons with normal liver enzymes. Liver biopsy may show a mix of fat, inflammation and scarring in the liver. Patients with NAFLD do not drink large amounts of alcohol that can cause this type of liver damage.

NAFLD is thought to be related to obesity and diabetes. Unfortunately, there is very little information about important features of NAFLD. These include biochemical, genetic and other features that may help to predict disease progression. The few known risk factors include high blood sugar and lipid levels. Patients with NAFLD often have resistance to the normal action of insulin, a hormone which is important for processing sugar and fat. Increased resistance to insulin leads to fat in the liver. Currently, there is no proven treatment for NAFLD. Several studies in animals suggest that diets containing high levels of omega-3 polyunsaturated fatty acids (PUFA) will decrease the amount of liver fat.

It has long been known that omega-3 fatty acids have several health benefits. For example, a diet rich in these fatty acids reduces the amount of certain fats ("triglycerides") in blood, and might improve the action of the important hormone insulin. Omega-3 fatty acids are contained in certain plant oils (such as canola oil and linseed oil) and marine fish (such as salmon). The purpose of this study is to determine the effect of dietary supplementation with ω-3 polyunsaturated vs monounsaturated fatty acids on intrahepatic fat content in patients with non-alcoholic fatty liver disease as determined by magnetic resonance spectroscopy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acceptance into NASH CRN Database Study
Exclusion from or unwillingness to participate in the NASH CRN PIVENS Study
Histological diagnosis or imaging study suggesting NAFLD with at least 20% steatosis
Willingness to maintain study diet for duration of the study
At least 18 years of age
No contraindication for MRI scanning (i.e., pacemaker, shunts etc)

Exclusion Criteria:

Use of lipid lowering drugs (i.e., statins and fibrate drugs)
Use of insulin or thiazolidinediones
Use of drugs possibly associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, or other known hepatotoxins) for more than 2 consecutive weeks in the 2 years prior to screening
Initiation of anti-diabetic drugs (insulin, biguanides, sulfonylureas, metformin, thiazolidinediones) in the 3 months prior to randomization
Initiation of anti-NASH drugs (thiazolidinediones, vitamin E, metformin, UDCA, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies, probiotics) in the 3 months prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230113

Contacts

Contact: Jim Nelson, PhD	206-221-4537	jamesn@medicine.washington.edu
Contact: Virginia Mugford, BS	206-221-4538	virginiam@medicine.washington.edu

Locations

United States, Washington
University of Washington Medical Center	Recruiting
Seattle, Washington, United States, 98195
Contact: Jim Nelson, PhD 206-221-4537 jamesn@medicine.washington.edu

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Kris V Kowdley, MD

University of Washington

More Information

No publications provided

Responsible Party:	Virginia Mason Medical Center ( Kris Kowdley MD )
Study ID Numbers:	DK61728-S2
Study First Received:	September 29, 2005
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00230113 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

NAFLD
NASH
Fatty Liver Disease
Omega-3 Fatty Acid
Fish oil

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases
Fatty Liver

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on May 07, 2009