Effect of Omega-3 PUFA Supplementation in NAFLD Patients

NCT00230113 | Completed Phase 2

• 1 other identifier: DK61728-S2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy

  2 month

Secondary Outcomes (2)

• Change in serum aminotransferase levels Change in lipid profile Change in levels of proinflammatory cytokines

  2 month

• Change in insulin resistance determined by HOMA

  2 month

Study Arms (2)

1

ACTIVE COMPARATOR

Dietary Supplement: Omega-3 fatty acid diet supplementation

2

PLACEBO COMPARATOR

Dietary Supplement: safflower oil

Interventions

Omega-3 fatty acid diet supplementation DIETARY_SUPPLEMENT

4 gm fish oil per day

1

safflower oil DIETARY_SUPPLEMENT

4 gm per day safflower oil

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acceptance into NASH CRN Database 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Safflower Oil

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kris V Kowdley, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: September 30, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

US (1)