- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880149
The Effects of Omega-3 Status and Supplementation on Tendon Structure in Competitive Athletes
September 29, 2020 updated by: Dan Nemet, MD, Meir Medical Center
The Effects of Omega-3 Status and Supplementation on Tendon Structure and Recovery From Sports Injuries in Competitive Athletes
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dan Nemet, MD
- Phone Number: 972-9-7471640
- Email: Dan.Nemet@clalit.org.il
Study Contact Backup
- Name: Michal Pantanowitz, PhD
- Phone Number: 972-9-7471596
- Email: michalmirochnik@gmail.com
Study Locations
-
-
-
Netanya, Israel, 4290200
- Recruiting
- Wingate Institute
-
Contact:
- Dan Nemet, MD
- Phone Number: +972-9-7471596
- Email: Dan.Nemet@clalit.org.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
|
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
|
Medium-chain triglyceride (MCT) and vitamin E
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory marker
Time Frame: 3 months
|
Serum interleukin 6 (IL-6) (pg/mL)
|
3 months
|
Muscle Strength
Time Frame: 6 months
|
Total work (Kjoule) (using Biodex isokinetic testing protocol)
|
6 months
|
Omega-3 status
Time Frame: 6 months
|
Distribution (%) of 26 identified fatty acids - measured in Blood
|
6 months
|
Cross sectional area of Achilles tendon
Time Frame: 6 months
|
measured using Ultrasound Tissue Characterization (UTC) (cm^2)
|
6 months
|
Range of motion - knee
Time Frame: 6 months
|
using digital inclinometer for range of motion measurement (degrees)
|
6 months
|
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
|
6 months
|
functional assessment
Time Frame: 3 months
|
VISA P questionnaire - scale 0-100
|
3 months
|
Pro-inflammatory cytokine.
Time Frame: 3 months
|
Serum interleukin 17 (IL-17) (pg/mL)
|
3 months
|
Marker for inflammation
Time Frame: 3 months
|
C Reactive Protein (CRP) (mg/L)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dan Nemet, MD, Meir Medical Center, Kfar-Saba, Israel
- Study Director: Yitzhak Weinstein, PhD, Tel Hai Academic College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
December 2, 2018
First Submitted That Met QC Criteria
March 17, 2019
First Posted (Actual)
March 19, 2019
Study Record Updates
Last Update Posted (Actual)
October 1, 2020
Last Update Submitted That Met QC Criteria
September 29, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MeirMc0242-18CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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