CompletedNot Applicable

Effect of Omega-3 PUFA Supplementation in NAFLD Patients

United States30 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested omega-3 fatty acid supplements specifically for reducing fat inside the liver, measured by MRI spectroscopy — since it's now completed, can you tell me what the results showed and whether omega-3 supplementation actually made a meaningful difference in liver fat for people like me?
2Because this study is finished, is the evidence from it strong enough to influence how you'd treat my non-alcoholic fatty liver disease today, or are there newer or larger studies you'd weigh more heavily?
3The trial used magnetic resonance spectroscopy to measure liver fat — is that kind of imaging something you'd use to track my progress too, or do you typically monitor NAFLD differently in routine care?
4Omega-3 supplements are available over the counter, so how does that affect the conversation — is there a specific dose or formulation from this type of research that you'd consider recommending, and are there any liver-related risks I should know about before trying it?
5Before considering omega-3 supplementation as part of my treatment, are there lifestyle changes or other standard approaches I should try first that have stronger evidence for reducing liver fat in NAFLD?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy

Timeframe: 2 month

Trial details

NCT IDNCT00230113

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

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2010-06

View on ClinicalTrials.gov More Non-Alcoholic Fatty Liver Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.