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

Not Applicable

• Conditions: Tendon Injuries; Inflammation
• Interventions: Dietary Supplement: Omega-3; Other: Placebo

• Registration Number: NCT03880149
• Lead Sponsor: Meir Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2019-03-17
• Study First Posted: 2019-03-19
• Study Start: 2020-02-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 supplementation	Omega-3	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
Placebo	Placebo	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Inflammatory marker	3 months	Serum interleukin 6 (IL-6) (pg/mL)
Marker for inflammation	3 months	C Reactive Protein (CRP) (mg/L)
Muscle Strength	6 months	Total work (Kjoule) (using Biodex isokinetic testing protocol)
Omega-3 status	6 months	Distribution (%) of 26 identified fatty acids - measured in Blood
Cross sectional area of Achilles tendon	6 months	measured using Ultrasound Tissue Characterization (UTC) (cm\^2)
Range of motion - knee	6 months	using digital inclinometer for range of motion measurement (degrees)
Pain assessment	6 months	pain severity using visual analog scale (VAS) - on a scale of 0 -10, 0 being no pain and 10 the worst pain ever
Pro-inflammatory cytokine.	3 months	Serum interleukin 17 (IL-17) (pg/mL)
functional assessment	3 months	VISA P questionnaire - scale 0-100

Trial Locations

Locations (1)

Wingate institute; 🇮🇱 Netanya, Israel