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

Primary Purpose

Non Alcoholic Fatty Liver Disease, Steatohepatitis, Hypertriglyceridemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Omega diet

About this trial

This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease focused on measuring fatty liver, hypertriglyceridemia, elevated liver enzymes

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

omega diet carrying CC/CG genotype

omega diet carrying GG genotype

Arm Description

Subjects homozygous for the major allele of the rs73049 SNP or heterozygous (CC and CG)

Subjects homozygous for the minor allele of the rs73049 SNP (GG)

Outcomes

Primary Outcome Measures

reduction in hepatic fat fraction

subjects follow study designed meal plan

Secondary Outcome Measures

reduction in triglycerides

subjects follow study designed meal plan

lower ALT levels

subjects follow study designed meal plan

Full Information

NCT ID

NCT01556113

First Posted

March 12, 2012

Last Updated

April 26, 2017

Sponsor

Yale University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT01556113

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

fatty liver, hypertriglyceridemia, elevated liver enzymes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

omega diet carrying CC/CG genotype

Arm Type

Active Comparator

Arm Description

Subjects homozygous for the major allele of the rs73049 SNP or heterozygous (CC and CG)

Arm Title

omega diet carrying GG genotype

Arm Type

Active Comparator

Arm Description

Subjects homozygous for the minor allele of the rs73049 SNP (GG)

Intervention Type

Other

Intervention Name(s)

Omega diet

Intervention Description

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

Primary Outcome Measure Information:

Title

reduction in hepatic fat fraction

Description

subjects follow study designed meal plan

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

reduction in triglycerides

Description

subjects follow study designed meal plan

Time Frame

12 weeks

Title

lower ALT levels

Description

subjects follow study designed meal plan

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicola Santoro, MD/PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32652034

Citation

Van Name MA, Savoye M, Chick JM, Galuppo BT, Feldstein AE, Pierpont B, Johnson C, Shabanova V, Ekong U, Valentino PL, Kim G, Caprio S, Santoro N. A Low omega-6 to omega-3 PUFA Ratio (n-6:n-3 PUFA) Diet to Treat Fatty Liver Disease in Obese Youth. J Nutr. 2020 Sep 1;150(9):2314-2321. doi: 10.1093/jn/nxaa183.

Results Reference

derived

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

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