Genotype-related Effects of PUFA

November 17, 2014 updated by: Nestlé

Response to PUFA Intervention According to PPAR Genotypes

To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult between 18 and 40 years of age
  • BMI between 18.5 and 30 kg/m2
  • Sedentary to moderate physical activity habits

Exclusion Criteria:

  • Concomitant treatment: Consumption of dietary supplements or any medication that can affect the study outcomes
  • Actively smoking
  • Suspected abuse of alcohol or illicit drugs
  • Significant illness within the two weeks prior to study start or any active systemic infection or medical condition that may require treatment during the study
  • Known or suspected medical condition related to coagulation
  • Subject who cannot be expected to comply with the study procedures
  • Currently participating or having participated in another clinical trial during the last 4 weeks prior to beginning of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplementation
Dietary supplement: Triple Strength Fish Oil
Triple Strength Fish Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in triglyceride levels in plasma
Time Frame: Baseline and 6 weeks intervention
Baseline and 6 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess bioefficacy of EPA and DHA supplementation
Time Frame: Baseline and 6 weeks intervention
The bioefficacy will be evaluated by characterizing and measuring the effects on lipid metabolism, glucose metabolism and insulin resistance, and inflammatory response
Baseline and 6 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Maria Elizabeth Tejero Barrera, PhD, Instituto Nacional de Medicina Genómica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11.16.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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