Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease
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.
Non Alcoholic Fatty Liver Disease
Alanine Aminotransferase, Plasma Level of, Quantitative Trait Locus 1
Other: Omega diet
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- reduction in hepatic fat fraction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- reduction in triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- lower ALT levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Active Comparator: omega diet
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 omega diet intervention than the common allele homozygous supplementation. Subjects entering the diet arm of the intervention will be provided food by the researchers for 12 weeks. (Meal plan provided in Appendix A.) The meal plan is an ω6/ω3 ratio will range between 4:1 to 3:1. Each subject will be instructed by an RD monthly to assist with adherence. Subjects will meet with the RD, or other study personnel, every 3-4 days for replenishment of food, anthropometric measurements, and compliance concerns.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556113
|Contact: Bridget Pierpont, M.A.||firstname.lastname@example.org|
|United States, Connecticut|
|Yale School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Bridget Pierpont, M.A. 203-785-2942 email@example.com|
|Contact: Melissa Shaw, B.A. 203-785-6459 firstname.lastname@example.org|
|Principal Investigator: Nicola Santoro, M.D./Ph.D.|
|Principal Investigator:||Nicola Santoro, MD/PhD||Yale University|