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Tendon InjuriesNCT03880149

The Effects of Omega-3 Status and Supplementation on Tendon Structure in Competitive Athletes

A study testing Omega-3 in people with Tendon Injuries and Inflammation, run by Meir Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study will examine the association between omega-3 status and the effects of omega-3 supplementation on changes in tendon structure and recovery from tendon injuries and inflammatory markers in competitive athletes. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Tendon Injuries, Inflammation
What is being tested?
Omega-3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteIsrael
Study dates
1 Feb 2020to 1 Jun 2021
Phase
Interventional
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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Part one:
  • Training for at least 5 hours per week.
  • No complaints about lower extremities pains during the last 12 months.
  • Part two:
  • Training for at least 5 hours per week.
  • Diagnosed with patellar and Achilles tendinitis.

Who cannot join

  • Underwent lower extremities surgeries.
  • Allergic to Fish products.
  • Athletes who use anti-inflammatory drugs and/or omega-3 supplements.
  • Pregnant and/or nursing mothers.

Trial locations and contacts

1 site in 1 country.

Dan Nemet, MD contact

972-9-7471640

Dan.Nemet@clalit.org.il

Michal Pantanowitz, PhD contact

972-9-7471596

michalmirochnik@gmail.com

Israel1 site, 1 recruiting

  • Wingate institute

    Netanya, 4290200

    Dan Nemet, MD, +972-9-7471596, Dan.Nemet@clalit.org.il

    Recruiting

Other trials in Israel

About this study

Official title: The Effects of Omega-3 Status and Supplementation on Tendon Structure and Recovery From Sports Injuries in Competitive Athletes

The study will examine the association between omega-3 status and the effects of omega-3 supplementation on changes in tendon structure and recovery from tendon injuries and inflammatory markers in competitive athletes. Half of the participants will receive omega-3 in combination with vitamin E, while the other half will receive a placebo and vitamin E.

Read the detailed description

Sports injuries are common among athletes, while injury prevention received much clinical attention, there is no consensus among clinicians and researchers as to which injury-causing factors are dominant. It has been suggested that increased training load may be the leading cause of sports injuries, since tendons are sensitive to changes in load, making them vulnerable to injury. Inflammation is one of the reversible risk factors to sports injuries, and there are numerous methods which are used to treat inflammation. It has been recently suggested that inflammation reactions are affected by Omega-3 status and that omega-3 deficiency may increase the risk of sports and tendon injuries. The omega-3 fatty acid may act as a regulator of membrane structure and function, intracellular signaling pathways, transcription factor activity, and gene expression and reducing inflammation. Due to these functions, omega-3 may influence exercise-induced injuries/inflammation in athletes, thus, may influence their health and allowing training.

Being tested
Omega-3, Placebo
Keywords
Omega-3, Athletes, Sports injuries, Inflammatory markers, Isokinetic muscle force
Medical subject headings
Tendon Injuries, Inflammation, Athletic Injuries

What participants receive

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

  • Omega-3Dietary supplement

    Each omega-3 capsule contains 600 mg, including 400 mg EPA + 200 mg Docosahexaenoic acid (DHA) and 400 IU of vitamin E for 5 omega-3 capsules. Omega-3 dosage: 1 g per 15 kg body mass

  • PlaceboOther

    Medium-chain triglyceride (MCT) and vitamin E

Study groups in NCT03880149
Study groupRoleWhat they receive
Omega-3 supplementationExperimentalOmega-3 fatty supplementation and vitamin E. Each 1 g omega-3 capsule contain 600 mg omega-3 including 400 mg EPA + 200 mg DHA. Individual omega-3 dose will be determined according to the athlete's body mass, 1 g omega-3 / 15 kg body mass per day and vitamin E: 1 capsule of vitamin E (400 IU) for every five omega-3 capsules
Receives: Dietary Supplement: Omega-3
PlaceboPlacebo comparatorMedium-chain triglyceride (MCT) and vitamin E. Each MCT capsule contain 1 g, the dose will be 115 mg per kg body mass per day, and vitamin E: 1 capsule of vitamin E (400 IU) for every five MCT capsules
Receives: Other: Placebo

What is being measured

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

  1. Tendon Structure

    Changes in the echo pattern of patellar and Achilles tendons structure using Ultrasound Tissue Characterization (UTC). Distribution (%) of echo type 1-3.

    Measured: 6 months

Secondary outcomes (9)

  1. Inflammatory marker

    Serum interleukin 6 (IL-6) (pg/mL)

    Measured: 3 months

  2. Muscle Strength

    Total work (Kjoule) (using Biodex isokinetic testing protocol)

    Measured: 6 months

  3. Omega-3 status

    Distribution (%) of 26 identified fatty acids - measured in Blood

    Measured: 6 months

  4. Cross sectional area of Achilles tendon

    measured using Ultrasound Tissue Characterization (UTC) (cm^2)

    Measured: 6 months

  5. Range of motion - knee

    using digital inclinometer for range of motion measurement (degrees)

    Measured: 6 months

  6. Pain assessment

    pain severity using visual analog scale (VAS) - on a scale of 0 -10, 0 being no pain and 10 the worst pain ever

    Measured: 6 months

  7. functional assessment

    VISA P questionnaire - scale 0-100

    Measured: 3 months

  8. Pro-inflammatory cytokine.

    Serum interleukin 17 (IL-17) (pg/mL)

    Measured: 3 months

  9. Marker for inflammation

    C Reactive Protein (CRP) (mg/L)

    Measured: 3 months

Timeline

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

  1. First posted19 Mar 2019
  2. Study start1 Feb 2020
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2021 (estimated)

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
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03880149
Sponsor's protocol ID
MeirMc0242-18CTIL
Status last verified
Sep 2020
First submitted
2 Dec 2018
Last updated
1 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Da Boit M, Hunter AM, Gray SR. Fit with good fat? The role of n-3 polyunsaturated fatty acids on exercise performance. Metabolism. 2017 Jan;66:45-54. doi: 10.1016/j.metabol.2016.10.007. Epub 2016 Oct 26.

    PubMed 27923448

  • Black KE, Witard OC, Baker D, Healey P, Lewis V, Tavares F, Christensen S, Pease T, Smith B. Adding omega-3 fatty acids to a protein-based supplement during pre-season training results in reduced muscle soreness and the better maintenance of explosive power in professional Rugby Union players. Eur J Sport Sci. 2018 Nov;18(10):1357-1367. doi: 10.1080/17461391.2018.1491626. Epub 2018 Jul 9.

    PubMed 29985775

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 in people with Tendon Injuries and Inflammation, run by Meir Medical Center at 1 site in Israel.

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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

Results are not available in the source record.

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

Contact Dan Nemet, MD (972-9-7471640, Dan.Nemet@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tendon Structure (time frame: 6 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 NCT03880149, which also lists 4 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 1 Oct 2020.

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