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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880149
• Other study ID #: MeirMc0242-18CTIL
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: Meir Medical Center
• Contact: Dan Nemet, MD
• Phone: 972-9-7471640
• Email: Dan.Nemet[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Tendon Injuries

Intervention

Dietary Supplement:
• Omega-3
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

Other:
• Placebo
Medium-chain triglyceride (MCT) and vitamin E

Locations

Country	Name	City	State
Israel	Wingate institute	Netanya

Sponsors (3)

Lead Sponsor	Collaborator
Meir Medical Center	Tel Hai College, University of Haifa

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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 pow — View Citation

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. Review. — View 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: 1 — View 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. — View Citation

Outcome

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