Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes
NCT ID: NCT02610270
Last Updated: 2015-11-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
EARLY_PHASE1
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-06-30
Study Completion Date
2015-04-30
Brief Summary
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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
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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.
Conditions
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Healthy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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2 Gums
Athletes that continued their usual training and diet, who took 2 gums of omega 3 (DHA 760 mg) during the experimental period.
Group Type
EXPERIMENTAL
2 Gums
Intervention Type
DIETARY_SUPPLEMENT
760 mg DHA
3 Gums
Athletes that continued their usual training and diet, who took 3 gums of omega 3 (DHA 1140 mg) during the experimental period.
Group Type
EXPERIMENTAL
3 Gums
Intervention Type
DIETARY_SUPPLEMENT
1140 mg DHA
Control
Athletes and coaches that continued their usual training and diet, but did not take any supplements during the experimental period.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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2 Gums
760 mg DHA
Intervention Type
DIETARY_SUPPLEMENT
3 Gums
1140 mg DHA
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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.
* During the study, any subject that falls under injury or need nonsteroidal antiinflammatory drug or get sick by inflammatory or infectious disease.
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Centre d'Alt Rendiment
OTHER
Sponsor Role
lead
Responsible Party
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FRANCISCO DROBNIC, MD, PhD
MD PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Franchek Drobnic, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Olympic Training Center, Centre d'Alt Rendiment CAR
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
DERIVED
Other Identifiers
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CAR-2
Identifier Type: -
Identifier Source: org_study_id