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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tendon Injuries, Inflammation

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 supplementation<br>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 | Dietary Supplement: Omega-3<br>* 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<br>|
| Placebo Comparator: Placebo<br>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 | Other: Placebo<br>* Medium-chain triglyceride (MCT) and vitamin E<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon Structure | Changes in the echo pattern of patellar and Achilles tendons structure using Ultrasound Tissue Characterization (UTC). Distribution (%) of echo type 1-3. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory marker | Serum interleukin 6 (IL-6) (pg/mL) | 3 months | 
| Muscle Strength | Total work (Kjoule) (using Biodex isokinetic testing protocol) | 6 months | 
| Omega-3 status | Distribution (%) of 26 identified fatty acids - measured in Blood | 6 months | 
| Cross sectional area of Achilles tendon | measured using Ultrasound Tissue Characterization (UTC) (cm^2) | 6 months | 
| Range of motion - knee | using digital inclinometer for range of motion measurement (degrees) | 6 months | 
| 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 | 6 months | 
| functional assessment | VISA P questionnaire - scale 0-100 | 3 months | 
| Pro-inflammatory cytokine. | Serum interleukin 17 (IL-17) (pg/mL) | 3 months | 
| Marker for inflammation | C Reactive Protein (CRP) (mg/L) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3, Athletes, Sports injuries, Inflammatory markers, Isokinetic muscle force