Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease

Hypertriglyceridemia Clinical Trial

Official title:

The Genetic Effect on Omega 3 Fatty Acid Supplementation for the Treatment of Non Alcoholic Fatty Liver Disease in Obese Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556113
• Other study ID #: 1112009408
• Secondary ID: R01HD040787
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: April 26, 2017
• Start date: March 2012
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Nonalcoholic fatty liver disease (NAFLD) is emerging as one of the most common complications of childhood obesity. It is associated with and predicts the metabolic syndrome, independent of overall obesity. Increased ALT levels are associated with deterioration in insulin sensitivity and glucose tolerance, as well as with increasing free fatty acid (FFA) and triglyceride levels. The prevalence of metabolic syndrome and prediabetes increases with the increases in hepatic fat content in a cohort of obese adolescents.

Fatty liver, independent of visceral and intramyocellular lipid content plays a central role in the impairment of liver, muscle and adipose insulin sensitivity in obese adolescents. Thus, fatty liver disease may be the hepatic component of the metabolic syndrome.

Omega 3 fatty acids lower plasma triglyceride concentrations. The subjects entering the omega diet study will be consuming an omega rich diet that is tailored to their caloric needs. This calculation is based on the patient's weight, age, and gender with the purpose of not modifying their weight at all. Weight maintenance is a very important factor in this arm of the study. They will be on the diet for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alanine Aminotransferase, Plasma Level of, Quantitative Trait Locus 1
• Fatty Liver
• Hypertriglyceridemia
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease
• Steatohepatitis

Intervention

Other:
• Omega diet
Eligible subjects will receive omega rich diet for 12 weeks with weekly appointments to obtain food records, draw serum samples and provide meals.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in hepatic fat fraction	subjects follow study designed meal plan	12 weeks
Secondary	reduction in triglycerides	subjects follow study designed meal plan	12 weeks
Secondary	lower ALT levels	subjects follow study designed meal plan	12 weeks