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HealthyEarly Phase 1O3SportNCT02610270

Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes

A Early Phase 1 study testing 2 Gums and 3 Gums in people with Healthy, run by Centre d'Alt Rendiment.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
2 Gums and 3 Gums
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Jun 2014to Apr 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
2 Gums, 3 Gums
Keywords
Sport, fatty acid, omega 3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2 GumsDietary supplement

    760 mg DHA

  • 3 GumsDietary supplement

    1140 mg DHA

Study groups in NCT02610270
Study groupRoleWhat they receive
2 GumsExperimentalAthletes that continued their usual training and diet, who took 2 gums of omega 3 (DHA 760 mg) during the experimental period.
Receives: Dietary Supplement: 2 Gums
3 GumsExperimentalAthletes that continued their usual training and diet, who took 3 gums of omega 3 (DHA 1140 mg) during the experimental period.
Receives: Dietary Supplement: 3 Gums
ControlNo interventionAthletes and coaches that continued their usual training and diet, but did not take any supplements during the experimental period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fatty acid levels at the membrane of the red blood cells

    Evaluation will be obtained before and after the experimental period

    Measured: Four months

Secondary outcomes (5)

  1. 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.

    Measured: Four months

  2. 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).

    Measured: Four months

  3. 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%)

    Measured: Four months

  4. 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

    Measured: Four months

  5. 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.

    Measured: Four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionJan 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02610270
Sponsor's protocol ID
CAR-2
Acronym
O3Sport
Status last verified
Nov 2015
First submitted
13 Nov 2015
Last updated
20 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22841917

  • 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.

    PubMed 24268818

  • 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.

    PubMed 24201219

  • 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.

    PubMed 23400626

  • 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.

    PubMed 19691834

  • 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.

    PubMed 26085822

  • 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.

    PubMed 25373094

  • 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.

    PubMed 23363551

  • 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.

    PubMed 24500439

  • 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.

    PubMed 25698680

  • 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.

    PubMed 15208005

  • 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.

    PubMed 24885361

  • 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.

    PubMed 25203220

  • 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.

    PubMed 25066733

  • 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.

    PubMed 24252845

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 2 Gums and 3 Gums in people with Healthy, run by Centre d'Alt Rendiment.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fatty acid levels at the membrane of the red blood cells (time frame: Four months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02610270, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

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