Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease
Completed · Not applicable
Conditions studied: Non Alcoholic Fatty Liver Disease, Steatohepatitis, Hypertriglyceridemia, Alanine Aminotransferase, Plasma Level of, Quantitative Trait Locus 1
In brief
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.
Key facts
- Study ID
- NCT01556113
- Run by
- Yale University
- People needed
- 17
- Starts
- 2012-03-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2017-04-28
Who can join
Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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)
Where it is running
- Yale School of Medicine — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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