Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: 2 Gums; Dietary Supplement: 3 Gums

• Registration Number: NCT02610270
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Status Verified: 2015-11
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-19
• Last Update Submitted: 2015-11-19
• Study First Posted: 2015-11-20
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 Gums	2 Gums	Athletes that continued their usual training and diet, who took 2 gums of omega 3 (DHA 760 mg) during the experimental period.
3 Gums	3 Gums	Athletes that continued their usual training and diet, who took 3 gums of omega 3 (DHA 1140 mg) during the experimental period.

Primary Outcome Measures

Name	Time	Method
fatty acid levels at the membrane of the red blood cells	Four months	Evaluation will be obtained before and after the experimental period

Secondary Outcome Measures

Name	Time	Method
Impregnation in relation to dosage administrated to the athletes	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.
Different level of impregnation of the red blood cells in relation to dosage and different age of the athletes	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.
Different level of impregnation of the red blood cells in relation to dosage and different previous omega 3 index of the athletes	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%)
Different level of impregnation of the red blood cells in relation to dosage and weight of the athletes	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).
Different level of impregnation of the red blood cells in relation to dosage and different sex of the athletes	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