Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes (O3Sport)
19 novembre 2015 aggiornato da: FRANCISCO DROBNIC, MD, PhD, Centre d'Alt Rendiment
Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
24
Fase
- Prima fase 1
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 2 Gums
Athletes that continued their usual training and diet, who took 2 gums of omega 3 (DHA 760 mg) during the experimental period.
|
760 mg DHA
|
|
Sperimentale: 3 Gums
Athletes that continued their usual training and diet, who took 3 gums of omega 3 (DHA 1140 mg) during the experimental period.
|
1140 mg DHA
|
|
Nessun intervento: Control
Athletes and coaches that continued their usual training and diet, but did not take any supplements during the experimental period.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
fatty acid levels at the membrane of the red blood cells
Lasso di tempo: Four months
|
Evaluation will be obtained before and after the experimental period
|
Four months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Impregnation in relation to dosage administrated to the athletes
Lasso di tempo: 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.
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and weight of the athletes
Lasso di tempo: 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).
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and different previous omega 3 index of the athletes
Lasso di tempo: 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%)
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and different sex of the athletes
Lasso di tempo: 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
|
Four months
|
|
Different level of impregnation of the red blood cells in relation to dosage and different age of the athletes
Lasso di tempo: 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.
|
Four months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Franchek Drobnic, MD PhD, Olympic Training Center, Centre d'Alt Rendiment CAR
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Michael-Titus AT, Priestley JV. Omega-3 fatty acids and traumatic neurological injury: from neuroprotection to neuroplasticity? Trends Neurosci. 2014 Jan;37(1):30-8. doi: 10.1016/j.tins.2013.10.005. Epub 2013 Nov 22.
- Yates CM, Calder PC, Ed Rainger G. Pharmacology and therapeutics of omega-3 polyunsaturated fatty acids in chronic inflammatory disease. Pharmacol Ther. 2014 Mar;141(3):272-82. doi: 10.1016/j.pharmthera.2013.10.010. Epub 2013 Nov 4.
- Mickleborough TD. Omega-3 polyunsaturated fatty acids in physical performance optimization. Int J Sport Nutr Exerc Metab. 2013 Feb;23(1):83-96. doi: 10.1123/ijsnem.23.1.83.
- Bloomer RJ, Larson DE, Fisher-Wellman KH, Galpin AJ, Schilling BK. Effect of eicosapentaenoic and docosahexaenoic acid on resting and exercise-induced inflammatory and oxidative stress biomarkers: a randomized, placebo controlled, cross-over study. Lipids Health Dis. 2009 Aug 19;8:36. doi: 10.1186/1476-511X-8-36.
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- Di Girolamo FG, Situlin R, Mazzucco S, Valentini R, Toigo G, Biolo G. Omega-3 fatty acids and protein metabolism: enhancement of anabolic interventions for sarcopenia. Curr Opin Clin Nutr Metab Care. 2014 Mar;17(2):145-50. doi: 10.1097/MCO.0000000000000032.
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- Drobnic F, Rueda F, Pons V, Banquells M, Cordobilla B, Domingo JC. Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response Pilot Study. J Lipids. 2017;2017:1472719. doi: 10.1155/2017/1472719. Epub 2017 Jun 1.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2014
Completamento primario (Effettivo)
1 gennaio 2015
Completamento dello studio (Effettivo)
1 aprile 2015
Date di iscrizione allo studio
Primo inviato
13 novembre 2015
Primo inviato che soddisfa i criteri di controllo qualità
19 novembre 2015
Primo Inserito (Stima)
20 novembre 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
20 novembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 novembre 2015
Ultimo verificato
1 novembre 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CAR-2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .