ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01556113
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Yale University

March 12, 2012
March 16, 2012
April 28, 2017
March 2012
February 2017   (Final data collection date for primary outcome measure)
reduction in hepatic fat fraction [ Time Frame: 12 weeks ]
subjects follow study designed meal plan
reduction in hepatic fat fraction [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01556113 on ClinicalTrials.gov Archive Site
  • reduction in triglycerides [ Time Frame: 12 weeks ]
    subjects follow study designed meal plan
  • lower ALT levels [ Time Frame: 12 weeks ]
    subjects follow study designed meal plan
Not Provided
Not Provided
Not Provided
 
Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease
The Genetic Effect on Omega 3 Fatty Acid Supplementation for the Treatment of Non Alcoholic Fatty Liver Disease in Obese Children and Adolescents

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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non Alcoholic Fatty Liver Disease
  • Steatohepatitis
  • Hypertriglyceridemia
  • Alanine Aminotransferase, Plasma Level of, Quantitative Trait Locus 1
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.
  • Active Comparator: omega diet carrying CC/CG genotype
    Subjects homozygous for the major allele of the rs73049 SNP or heterozygous (CC and CG)
    Intervention: Other: Omega diet
  • Active Comparator: omega diet carrying GG genotype
    Subjects homozygous for the minor allele of the rs73049 SNP (GG)
    Intervention: Other: Omega diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
60
February 2017
February 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
10 Years to 19 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01556113
1112009408
R01HD040787 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Yale University
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Nicola Santoro, MD/PhD Yale University
Yale University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP