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

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Clalit Health Services

Status

Unknown

Conditions

Inflammation
Tendon Injuries

Treatments

Dietary Supplement: Omega-3
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03880149
MeirMc0242-18CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

140 participants in 2 patient groups, including a placebo group

Omega-3 supplementation
Experimental group
Description:
Omega-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
Treatment:
Dietary Supplement: Omega-3
Placebo
Placebo Comparator group
Description:
Medium-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
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Michal Pantanowitz, PhD; Dan Nemet, MD

Data sourced from clinicaltrials.gov

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