Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01556113
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date February 2017

See also
  Status Clinical Trial Phase
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT02250105 - Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia Phase 2
Completed NCT02859129 - Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) Phase 1
Completed NCT01455844 - TRIal For Efficacy of Capre on hyperTriglyceridemiA Phase 2
Completed NCT01437930 - Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients N/A
Completed NCT01010399 - Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects Phase 4
Completed NCT00959842 - Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia Phase 1/Phase 2
Completed NCT00519714 - A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA) Phase 2/Phase 3
Recruiting NCT00186537 - Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. N/A
Completed NCT00246402 - Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV N/A
Completed NCT06020950 - Chia Seeds Consumption in Hypertriglyceridemia N/A
Completed NCT02354976 - A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. Phase 2
Completed NCT04966494 - Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women N/A
Completed NCT04630366 - A Phase 1, First Time in Humans Study of NST-1024 Phase 1
Completed NCT04650152 - Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Completed NCT03693131 - Efficacy of MND-2119 in Participants With Hypertriglyceridemia Phase 3
Completed NCT02868177 - Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes Phase 2/Phase 3
Completed NCT04756180 - An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia. Phase 3
Completed NCT01968720 - Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia Phase 2
Completed NCT01462877 - A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic Phase 4