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

NCT ID: NCT03880149

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-06-01

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.

Conditions

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Tendon Injuries Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Omega-3 supplementation

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

Group Type EXPERIMENTAL

Omega-3

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Medium-chain triglyceride (MCT) and vitamin E

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Medium-chain triglyceride (MCT) and vitamin E

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Haifa

OTHER

Sponsor Role collaborator

Tel Hai College

OTHER

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dan Nemet, MD

Professor of Pediatrics. Director, Child Health and Sports Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Nemet, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center, Kfar-Saba, Israel

Gali Dar, PhD

Role: STUDY_DIRECTOR

University of Haifa

Yitzhak Weinstein, PhD

Role: STUDY_DIRECTOR

Tel Hai Academic College

Locations

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Wingate institute

Netanya, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Dan Nemet, MD

Role: CONTACT

972-9-7471640

Michal Pantanowitz, PhD

Role: CONTACT

972-9-7471596

Facility Contacts

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Dan Nemet, MD

Role: primary

+972-9-7471596

References

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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.

Reference Type BACKGROUND
PMID: 27923448 (View on PubMed)

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.

Reference Type RESULT
PMID: 29985775 (View on PubMed)

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.

Reference Type RESULT
PMID: 26085822 (View on PubMed)

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.

Reference Type RESULT
PMID: 25203220 (View on PubMed)

Other Identifiers

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MeirMc0242-18CTIL

Identifier Type: -

Identifier Source: org_study_id

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