Clinical trial NCT03880149: The Effects of Omega-3 Status and Supplementation on Tendon Structure in Competitive Athletes
Official title: The Effects of Omega-3 Status and Supplementation on Tendon Structure and Recovery From Sports Injuries in Competitive Athletes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tendon Injuries
Inflammation
Keywords: Omega-3
Athletes
Sports injuries
Inflammatory markers
Isokinetic muscle force
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: University of Haifa
name: Tel Hai College
First posted: 2019-03-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. Half of the participants will receive omega-3 in combination with vitamin E, while the other half will receive a placebo and vitamin E.

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Tendon Structure
timeFrame: 6 months
Secondary outcomes:
measure: Inflammatory marker
timeFrame: 3 months
measure: Muscle Strength
timeFrame: 6 months
measure: Omega-3 status
timeFrame: 6 months
measure: Cross sectional area of Achilles tendon
timeFrame: 6 months
measure: Range of motion - knee
timeFrame: 6 months
measure: Pain assessment
timeFrame: 6 months
measure: functional assessment
timeFrame: 3 months
measure: Pro-inflammatory cytokine.
timeFrame: 3 months
measure: Marker for inflammation
timeFrame: 3 months
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate institute
Study officials:
affiliation: Meir Medical Center, Kfar-Saba, Israel
name: Dan Nemet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Haifa
name: Gali Dar, PhD
role: STUDY_DIRECTOR
affiliation: Tel Hai Academic College
name: Yitzhak Weinstein, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.