Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes (O3Sport)
19 de noviembre de 2015 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
24
Fase
- Fase temprana 1
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
|
|
Experimental: 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
|
|
Sin intervención: Control
Athletes and coaches that continued their usual training and diet, but did not take any supplements during the experimental period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
fatty acid levels at the membrane of the red blood cells
Periodo de tiempo: Four months
|
Evaluation will be obtained before and after the experimental period
|
Four months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Impregnation in relation to dosage administrated to the athletes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Franchek Drobnic, MD PhD, Olympic Training Center, Centre d'Alt Rendiment CAR
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25. Erratum In: N Engl J Med. 2014 Feb 27;370(9):886.
- Arterburn LM, Hall EB, Oken H. Distribution, interconversion, and dose response of n-3 fatty acids in humans. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1467S-1476S. doi: 10.1093/ajcn/83.6.1467S.
- Cao J, Schwichtenberg KA, Hanson NQ, Tsai MY. Incorporation and clearance of omega-3 fatty acids in erythrocyte membranes and plasma phospholipids. Clin Chem. 2006 Dec;52(12):2265-72. doi: 10.1373/clinchem.2006.072322. Epub 2006 Oct 19.
- Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.
- Welch RW, Antoine JM, Berta JL, Bub A, de Vries J, Guarner F, Hasselwander O, Hendriks H, Jakel M, Koletzko BV, Patterson CC, Richelle M, Skarp M, Theis S, Vidry S, Woodside JV; International Life Sciences Institute Europe Functional Foods Task Force. Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr. 2011 Nov;106 Suppl 2:S3-15. doi: 10.1017/S0007114511003606.
- Skulas-Ray AC, Kris-Etherton PM, Harris WS, Vanden Heuvel JP, Wagner PR, West SG. Dose-response effects of omega-3 fatty acids on triglycerides, inflammation, and endothelial function in healthy persons with moderate hypertriglyceridemia. Am J Clin Nutr. 2011 Feb;93(2):243-52. doi: 10.3945/ajcn.110.003871. Epub 2010 Dec 15.
- Luchtman DW, Song C. Cognitive enhancement by omega-3 fatty acids from child-hood to old age: findings from animal and clinical studies. Neuropharmacology. 2013 Jan;64:550-65. doi: 10.1016/j.neuropharm.2012.07.019. Epub 2012 Jul 27.
- 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.
- Lewis EJ, Radonic PW, Wolever TM, Wells GD. 21 days of mammalian omega-3 fatty acid supplementation improves aspects of neuromuscular function and performance in male athletes compared to olive oil placebo. J Int Soc Sports Nutr. 2015 Jun 18;12:28. doi: 10.1186/s12970-015-0089-4. eCollection 2015.
- Bailes JE, Patel V. The potential for DHA to mitigate mild traumatic brain injury. Mil Med. 2014 Nov;179(11 Suppl):112-6. doi: 10.7205/MILMED-D-14-00139.
- Hasadsri L, Wang BH, Lee JV, Erdman JW, Llano DA, Barbey AK, Wszalek T, Sharrock MF, Wang HJ. Omega-3 fatty acids as a putative treatment for traumatic brain injury. J Neurotrauma. 2013 Jun 1;30(11):897-906. doi: 10.1089/neu.2012.2672. Epub 2013 Jun 5.
- 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.
- Skulas-Ray AC. Omega-3 fatty acids and inflammation: a perspective on the challenges of evaluating efficacy in clinical research. Prostaglandins Other Lipid Mediat. 2015 Jan-Mar;116-117:104-11. doi: 10.1016/j.prostaglandins.2015.02.001. Epub 2015 Feb 16.
- Enns JE, Yeganeh A, Zarychanski R, Abou-Setta AM, Friesen C, Zahradka P, Taylor CG. The impact of omega-3 polyunsaturated fatty acid supplementation on the incidence of cardiovascular events and complications in peripheral arterial disease: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2014 May 31;14:70. doi: 10.1186/1471-2261-14-70.
- von Schacky C, Kemper M, Haslbauer R, Halle M. Low Omega-3 Index in 106 German elite winter endurance athletes: a pilot study. Int J Sport Nutr Exerc Metab. 2014 Oct;24(5):559-64. doi: 10.1123/ijsnem.2014-0041. Epub 2014 Sep 8.
- Delodder F, Tappy L, Liaudet L, Schneiter P, Perrudet C, Berger MM. Incorporation and washout of n-3 PUFA after high dose intravenous and oral supplementation in healthy volunteers. Clin Nutr. 2015 Jun;34(3):400-8. doi: 10.1016/j.clnu.2014.07.005. Epub 2014 Jul 15.
- Flock MR, Skulas-Ray AC, Harris WS, Etherton TD, Fleming JA, Kris-Etherton PM. Determinants of erythrocyte omega-3 fatty acid content in response to fish oil supplementation: a dose-response randomized controlled trial. J Am Heart Assoc. 2013 Nov 19;2(6):e000513. doi: 10.1161/JAHA.113.000513.
- Walker CG, Browning LM, Mander AP, Madden J, West AL, Calder PC, Jebb SA. Age and sex differences in the incorporation of EPA and DHA into plasma fractions, cells and adipose tissue in humans. Br J Nutr. 2014 Feb;111(4):679-89. doi: 10.1017/S0007114513002985. Epub 2013 Sep 24.
- Katan MB, Deslypere JP, van Birgelen AP, Penders M, Zegwaard M. Kinetics of the incorporation of dietary fatty acids into serum cholesteryl esters, erythrocyte membranes, and adipose tissue: an 18-month controlled study. J Lipid Res. 1997 Oct;38(10):2012-22.
- Harris WS, Mozaffarian D, Lefevre M, Toner CD, Colombo J, Cunnane SC, Holden JM, Klurfeld DM, Morris MC, Whelan J. Towards establishing dietary reference intakes for eicosapentaenoic and docosahexaenoic acids. J Nutr. 2009 Apr;139(4):804S-19S. doi: 10.3945/jn.108.101329. Epub 2009 Feb 25.
- Aranceta J, Perez-Rodrigo C. Recommended dietary reference intakes, nutritional goals and dietary guidelines for fat and fatty acids: a systematic review. Br J Nutr. 2012 Jun;107 Suppl 2:S8-22. doi: 10.1017/S0007114512001444.
- Gomez Candela C, Bermejo Lopez LM, Loria Kohen V. Importance of a balanced omega 6/omega 3 ratio for the maintenance of health: nutritional recommendations. Nutr Hosp. 2011 Mar-Apr;26(2):323-9. doi: 10.1590/S0212-16112011000200013.
- Browning LM, Walker CG, Mander AP, West AL, Madden J, Gambell JM, Young S, Wang L, Jebb SA, Calder PC. Incorporation of eicosapentaenoic and docosahexaenoic acids into lipid pools when given as supplements providing doses equivalent to typical intakes of oily fish. Am J Clin Nutr. 2012 Oct;96(4):748-58. doi: 10.3945/ajcn.112.041343. Epub 2012 Aug 29.
- Tartibian B, Maleki BH, Abbasi A. The effects of omega-3 supplementation on pulmonary function of young wrestlers during intensive training. J Sci Med Sport. 2010 Mar;13(2):281-6. doi: 10.1016/j.jsams.2008.12.634. Epub 2009 Jun 12.
- Drobnic F, CordobillaB, Rueda F, Domingo JC. Caracterización de diferentes suplementos de ácidos omega-3 en su aplicación en las edades pediátricas Acta Pediatr Esp. 2013; 71(11): e353-e357
- Flock MR, Harris WS, Kris-Etherton PM. Long-chain omega-3 fatty acids: time to establish a dietary reference intake. Nutr Rev. 2013 Oct;71(10):692-707. doi: 10.1111/nure.12071. Epub 2013 Oct 3.
- Lemaitre RN, Tanaka T, Tang W, Manichaikul A, Foy M, Kabagambe EK, Nettleton JA, King IB, Weng LC, Bhattacharya S, Bandinelli S, Bis JC, Rich SS, Jacobs DR Jr, Cherubini A, McKnight B, Liang S, Gu X, Rice K, Laurie CC, Lumley T, Browning BL, Psaty BM, Chen YD, Friedlander Y, Djousse L, Wu JH, Siscovick DS, Uitterlinden AG, Arnett DK, Ferrucci L, Fornage M, Tsai MY, Mozaffarian D, Steffen LM. Genetic loci associated with plasma phospholipid n-3 fatty acids: a meta-analysis of genome-wide association studies from the CHARGE Consortium. PLoS Genet. 2011 Jul;7(7):e1002193. doi: 10.1371/journal.pgen.1002193. Epub 2011 Jul 28.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2014
Finalización primaria (Actual)
1 de enero de 2015
Finalización del estudio (Actual)
1 de abril de 2015
Fechas de registro del estudio
Enviado por primera vez
13 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
19 de noviembre de 2015
Publicado por primera vez (Estimar)
20 de noviembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
19 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CAR-2
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .