Effect of Omega-3 PUFA Supplementation in NAFLD Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00230113
First received: September 29, 2005
Last updated: July 9, 2013
Last verified: July 2013

September 29, 2005
July 9, 2013
September 2005
June 2010   (final data collection date for primary outcome measure)
Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy [ Time Frame: 2 month ] [ Designated as safety issue: No ]
• Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy
Complete list of historical versions of study NCT00230113 on ClinicalTrials.gov Archive Site
  • 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 ]
  • • Change in serum aminotransferase levels
  • • Change in lipid profile
  • • Change in levels of proinflammatory cytokines
  • • Change in insulin resistance determined by HOMA
Not Provided
Not Provided
 
Effect of Omega-3 PUFA Supplementation in NAFLD Patients
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Non-Alcoholic Fatty Liver Disease
  • Dietary Supplement: Omega-3 fatty acid diet supplementation
    4 gm fish oil per day
  • Dietary Supplement: safflower oil
    4 gm per day safflower oil
  • Active Comparator: 1
    Intervention: Dietary Supplement: Omega-3 fatty acid diet supplementation
  • Placebo Comparator: 2
    Intervention: Dietary Supplement: safflower oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230113
DK61728-S2
No
Kris Kowdley MD, Virginia Mason Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Kris V Kowdley, MD University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP