NCT02296385

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable healthy

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

June 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

November 12, 2014

Last Update Submit

November 17, 2014

Conditions

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • Changes in triglyceride levels in plasma

    Baseline and 6 weeks intervention

Secondary Outcomes (1)

  • Assess bioefficacy of EPA and DHA supplementation

    Baseline and 6 weeks intervention

Study Arms (1)

Supplementation

EXPERIMENTAL

Supplementation

Dietary Supplement: Triple Strength Fish Oil

Interventions

Triple Strength Fish OilDIETARY_SUPPLEMENT

Triple Strength Fish Oil

Supplementation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Binia A, Vargas-Martinez C, Ancira-Moreno M, Gosoniu LM, Montoliu I, Gamez-Valdez E, Soria-Contreras DC, Angeles-Quezada A, Gonzalez-Alberto R, Fernandez S, Martinez-Conde D, Hernandez-Moran B, Ramirez-Solano M, Perez-Ortega C, Rodriguez-Carmona Y, Castan I, Rubio-Aliaga I, Vadillo-Ortega F, Marquez-Velasco R, Bojalil R, Lopez-Alvarenga JC, Valet P, Kussmann M, Silva-Zolezzi I, Tejero ME. Improvement of cardiometabolic markers after fish oil intervention in young Mexican adults and the role of PPARalpha L162V and PPARgamma2 P12A. J Nutr Biochem. 2017 May;43:98-106. doi: 10.1016/j.jnutbio.2017.02.002. Epub 2017 Feb 10.

Study Officials

  • Maria Elizabeth Tejero Barrera, PhD

    Instituto Nacional de Medicina Genomica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 20, 2014

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11