Clinical trial NCT02610270: Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes
Official title: Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Sport
fatty acid
omega 3
Lead sponsor: Centre d'Alt Rendiment
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: fatty acid levels at the membrane of the red blood cells
timeFrame: Four months
Secondary outcomes:
measure: Impregnation in relation to dosage administrated to the athletes
timeFrame: Four months
measure: Different level of impregnation of the red blood cells in relation to dosage and weight of the athletes
timeFrame: Four months
measure: Different level of impregnation of the red blood cells in relation to dosage and different previous omega 3 index of the athletes
timeFrame: Four months
measure: Different level of impregnation of the red blood cells in relation to dosage and different sex of the athletes
timeFrame: Four months
measure: Different level of impregnation of the red blood cells in relation to dosage and different age of the athletes
timeFrame: Four months
Other outcomes:
Locations:
Study officials:
affiliation: Olympic Training Center, Centre d'Alt Rendiment CAR
name: Franchek Drobnic, MD PhD
role: PRINCIPAL_INVESTIGATOR
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