NCT01556113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

4.9 years

First QC Date

March 12, 2012

Last Update Submit

April 26, 2017

Conditions

Non Alcoholic Fatty Liver DiseaseSteatohepatitisHypertriglyceridemiaAlanine Aminotransferase, Plasma Level of, Quantitative Trait Locus 1

Keywords

fatty liverhypertriglyceridemiaelevated liver enzymes

Outcome Measures

Primary Outcomes (1)

  • reduction in hepatic fat fraction

    subjects follow study designed meal plan

    12 weeks

Secondary Outcomes (2)

  • reduction in triglycerides

    12 weeks

  • lower ALT levels

    12 weeks

Study Arms (2)

omega diet carrying CC/CG genotype

ACTIVE COMPARATOR

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

Other: Omega diet

omega diet carrying GG genotype

ACTIVE COMPARATOR

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

Other: Omega diet

Interventions

Omega dietOTHER

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

omega diet carrying CC/CG genotypeomega diet carrying GG genotype

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 32652034DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty LiverHypertriglyceridemia

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nicola Santoro, MD/PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 16, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)