Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease (NCT01556113) | Clinical Trial Compass
CompletedNot Applicable
Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease
United States17 participantsStarted 2012-03
Plain-language summary
To explore whether there is a different response to omega-3 fatty acid rich diet with respect to the hepatic fat fraction % (HFF), triglyceride, and ALT levels between the rs738409 minor allele (GG) and the common allele homozygous (CC) of PNPLA3.
Hypothesis: We expect that subjects homozygous for the minor allele of the rs73049 SNP will lower their triglyceride, hepatic fat content, and ALT levels more with dietary intervention than the common allele homozygous supplementation.
Who can participate
Age range
10 Years – 19 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:
* 10 to 19 years of age
* BMI equal or greater than the 95th percentile for age and gender
* Genotype PNPLA3 CC or GG
* Liver MRI Hepatic Fat fraction ≥5.5%
Exclusion Criteria:
* Food allergy to fish or any components of the pills which include alpha tocopherol partially hydrogenated vegetable oils including soybean oils, gelatin, glycerol, corn or iron oxide
* Pregnant or breastfeeding
* Known bleeding disorder or coagulopathy or treatment with anticoagulant mechanisms or low platelet counts, abnormal PT or PTT
* Impaired glucose tolerance, Type 1 or 2 diabetes
* Birth control pills
* Alcohol consumption
* Other liver disease
* Taking any medication that alters triglyceride levels, liver function, blood pressure, glucose or lipid metabolism
* Taking over the counter supplements that affect triglycerides or lipid metabolism including fish oil supplements
* Treatment for or diagnosis of thyroid disorder or have an elevated TSH at baseline
* Use of any antipsychotic medication
* Taking chronic anti-inflammatory medications
* Less than 100 pounds (45 kg)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.