Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: 2 Gums
* Dietary Supplement: 3 Gums


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 Gums<br>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<br>* 760 mg DHA<br>|
| Experimental: 3 Gums<br>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<br>* 1140 mg DHA<br>|
| No Intervention: Control<br>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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sport, fatty acid, omega 3