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

Sponsor
Meir Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03880149
Collaborator
University of Haifa (Other), Tel Hai College (Other)
140
1
2
16
8.8

Study Details

Study Description

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
  • Dietary Supplement: Omega-3
  • Other: Placebo
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Inflammatory marker [3 months]

    Serum interleukin 6 (IL-6) (pg/mL)

  2. Muscle Strength [6 months]

    Total work (Kjoule) (using Biodex isokinetic testing protocol)

  3. Omega-3 status [6 months]

    Distribution (%) of 26 identified fatty acids - measured in Blood

  4. Cross sectional area of Achilles tendon [6 months]

    measured using Ultrasound Tissue Characterization (UTC) (cm^2)

  5. Range of motion - knee [6 months]

    using digital inclinometer for range of motion measurement (degrees)

  6. 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

  7. functional assessment [3 months]

    VISA P questionnaire - scale 0-100

  8. Pro-inflammatory cytokine. [3 months]

    Serum interleukin 17 (IL-17) (pg/mL)

  9. Marker for inflammation [3 months]

    C Reactive Protein (CRP) (mg/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wingate institute Netanya Israel 4290200

Sponsors and Collaborators

  • Meir Medical Center
  • University of Haifa
  • Tel Hai College

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Mar 19, 2019
Last Update Posted:
Oct 1, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dan Nemet, MD, Professor of Pediatrics. Director, Child Health and Sports Center, Meir Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2020