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

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ClinicalTrials.gov Identifier: NCT02610270
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
FRANCISCO DROBNIC, MD, PhD, Centre d'Alt Rendiment

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: 2 Gums Dietary Supplement: 3 Gums Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610270


Sponsors and Collaborators
Centre d'Alt Rendiment
Investigators
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Principal Investigator: Franchek Drobnic, MD PhD Olympic Training Center, Centre d'Alt Rendiment CAR
Publications:
Drobnic F, CordobillaB, Rueda F, Domingo JC. Caracterización de diferentes suplementos de ácidos omega-3 en su aplicación en las edades pediátricas Acta Pediatr Esp. 2013; 71(11): e353-e357

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: FRANCISCO DROBNIC, MD, PhD, MD PhD, Centre d'Alt Rendiment
ClinicalTrials.gov Identifier: NCT02610270    
Other Study ID Numbers: CAR-2
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by FRANCISCO DROBNIC, MD, PhD, Centre d'Alt Rendiment:
Sport
fatty acid
omega 3