An Early Phase 1 interventional study of 2 Gums and 3 Gums in Healthy, sponsored by Centre d'Alt Rendiment. Completed. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Centre d'Alt Rendiment · Early Phase 1, Interventional, and Basic science
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.
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.
Centre d'Alt Rendiment is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Athletes and coaches that continued their usual training and diet, but did not take any supplements during the experimental period.
760 mg DHA
1140 mg DHA
fatty acid levels at the membrane of the red blood cells
Evaluation will be obtained before and after the experimental period
Time frame: Four months
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.
Time frame: 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).
Time frame: 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%)
Time frame: 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
Time frame: 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.
Time frame: Four months
No study locations are listed for this record.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Centre d'Alt Rendiment