Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes (O3Sport)

November 19, 2015 updated by: FRANCISCO DROBNIC, MD, PhD, Centre d'Alt Rendiment

Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response

A suitable concentration of omega-3 fatty acids in relation to omega 6 is considered necessary for a good cell function and prevention of various inflammatory processes. Diet and supplementation are the fundamental procedures to achieve the reference values for several years. Athletes are individuals under physical stress and higher tissue restoration, while maintaining adequate diets they show, as the rest of humans, lower than desired levels. In the present study the investigators aims to determine the modification of those levels by the administration of two different doses of a given product, keeping the same model of diet and physical and competition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to assess concentrations of the different fatty acids in the erythrocyte membrane before and after administration of a compound with high quality omega3 (EPA and DHA) in two different doses, compared with control group . The period of evaluation and management is four months, one month for the proposed renewal of red blood cells. The composition of the diet, the sports calendar, caloric expenditure and level of training is determined. During the study process it is excluded subjects with injuries or disease processes and ensure that no one take any supplement or modify workouts or diet.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Early Phase 1

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, young men and women athletes from the Olympic Training Center (OTC) of Sant Cugat del Valles in Barcelona (Spain) (20 to 45 years of age) belonging to different summer sport activities were asked to participate.

Exclusion Criteria:

  • Any type of inflammatory process, or the use of anti-inflammatory medications, consumption of n-3 Fatty Acids (FA) supplements and n-3 FA-supplemented foods in the past 3 months; planning to change dietary habits, or training schedule.
  • During the study, any subject that falls under injury or need nonsteroidal antiinflammatory drug or get sick by inflammatory or infectious disease.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 Gums
Athletes that continued their usual training and diet, who took 2 gums of omega 3 (DHA 760 mg) during the experimental period.
Dietary supplement: 2 Gums
760 mg DHA
Experimental: 3 Gums
Athletes that continued their usual training and diet, who took 3 gums of omega 3 (DHA 1140 mg) during the experimental period.
Dietary supplement: 3 Gums
1140 mg DHA
No Intervention: Control
Athletes and coaches that continued their usual training and diet, but did not take any supplements during the experimental period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatty acid levels at the membrane of the red blood cells
Time Frame: Four months
Evaluation will be obtained before and after the experimental period
Four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impregnation in relation to dosage administrated to the athletes
Time Frame: Four months
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the subjects characteristics, sex (M,F), omega3 index (EPA/DHA%), weight (kg), age(years), etc. looking for a relationships of better or worse impregnation depending on sex, body weight, body mass index, previous level of omega3, etc.
Four months
Different level of impregnation of the red blood cells in relation to dosage and weight of the athletes
Time Frame: Four months
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the subjects characteristics, weight (kg).
Four months
Different level of impregnation of the red blood cells in relation to dosage and different previous omega 3 index of the athletes
Time Frame: Four months
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the subjects characteristic of previous level of omega3 index (EPA/DHA%)
Four months
Different level of impregnation of the red blood cells in relation to dosage and different sex of the athletes
Time Frame: Four months
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the sex (M,F) of the subjects
Four months
Different level of impregnation of the red blood cells in relation to dosage and different age of the athletes
Time Frame: Four months
Evaluate the impregnation level of the membrane of red blood cells, taken into account the two dosages in relation of the age(years) of the subjects etc.
Four months

Collaborators and Investigators

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

Sponsor

Centre d'Alt Rendiment

Investigators

  • Principal Investigator: Franchek Drobnic, MD PhD, Olympic Training Center, Centre d'Alt Rendiment CAR

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, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAR-2

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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