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NCT Number: NCT02610270

Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes

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.

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Key information

Conditions

Healthy

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2 Gums

Dietary Supplement

760 mg DHA

3 Gums

Dietary Supplement

1140 mg DHA

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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%)

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Centre d'Alt Rendiment

Other

Registry information

Official study title

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

Acronym: O3Sport

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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