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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880149
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : October 1, 2020
Sponsor:
Collaborators:
University of Haifa
Tel Hai College
Information provided by (Responsible Party):
Dan Nemet, MD, 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.

Condition or disease Intervention/treatment Phase
Tendon Injuries Inflammation Dietary Supplement: Omega-3 Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: The Effects of Omega-3 Status and Supplementation on Tendon Structure and Recovery From Sports Injuries in Competitive Athletes
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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

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




Primary Outcome Measures :
  1. Tendon Structure [ Time Frame: 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 :
  1. Inflammatory marker [ Time Frame: 3 months ]
    Serum interleukin 6 (IL-6) (pg/mL)

  2. Muscle Strength [ Time Frame: 6 months ]
    Total work (Kjoule) (using Biodex isokinetic testing protocol)

  3. Omega-3 status [ Time Frame: 6 months ]
    Distribution (%) of 26 identified fatty acids - measured in Blood

  4. Cross sectional area of Achilles tendon [ Time Frame: 6 months ]
    measured using Ultrasound Tissue Characterization (UTC) (cm^2)

  5. Range of motion - knee [ Time Frame: 6 months ]
    using digital inclinometer for range of motion measurement (degrees)

  6. Pain assessment [ Time Frame: 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

  7. functional assessment [ Time Frame: 3 months ]
    VISA P questionnaire - scale 0-100

  8. Pro-inflammatory cytokine. [ Time Frame: 3 months ]
    Serum interleukin 17 (IL-17) (pg/mL)

  9. Marker for inflammation [ Time Frame: 3 months ]
    C Reactive Protein (CRP) (mg/L)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880149


Contacts
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Contact: Dan Nemet, MD 972-9-7471640 Dan.Nemet@clalit.org.il
Contact: Michal Pantanowitz, PhD 972-9-7471596 michalmirochnik@gmail.com

Locations
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Israel
Wingate institute Recruiting
Netanya, Israel, 4290200
Contact: Dan Nemet, MD    +972-9-7471596    Dan.Nemet@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
University of Haifa
Tel Hai College
Investigators
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Principal Investigator: Dan Nemet, MD Meir Medical Center, Kfar-Saba, Israel
Study Director: Gali Dar, PhD University of Haifa
Study Director: Yitzhak Weinstein, PhD Tel Hai Academic College
Publications of Results:
Other Publications:
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Responsible Party: Dan Nemet, MD, Professor of Pediatrics. Director, Child Health and Sports Center, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03880149    
Other Study ID Numbers: MeirMc0242-18CTIL
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Nemet, MD, Meir Medical Center:
Omega-3
Athletes
Sports injuries
Inflammatory markers
Isokinetic muscle force
Additional relevant MeSH terms:
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Inflammation
Tendon Injuries
Wounds and Injuries
Pathologic Processes