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| Name | Class |
|---|---|
| University of Haifa | OTHER |
| Tel Hai College | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 supplementation | Experimental | 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 Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Part one:
Part two:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Nemet, MD | Contact | 972-9-7471640 | Dan.Nemet@clalit.org.il | |
| Michal Pantanowitz, PhD | Contact | 972-9-7471596 | michalmirochnik@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Nemet, MD | Meir Medical Center, Kfar-Saba, Israel | Principal Investigator |
| Gali Dar, PhD | University of Haifa | Study Director |
| Yitzhak Weinstein, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wingate institute | Recruiting | Netanya | 4290200 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27923448 | Background | 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. | |
| 29985775 | Result | 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. |
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| ID | Term |
|---|---|
| D013708 | Tendon Injuries |
| D007249 | Inflammation |
| D001265 | Athletic Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Placebo | Other | Medium-chain triglyceride (MCT) and vitamin E |
|
| 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 |
| Tel Hai Academic College |
| Study Director |
| 26085822 | Result | 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. |
| 25203220 | Result | 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. |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |