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

Primary Purpose

Tendon Injuries, Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Omega-3
Placebo
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tendon Injuries focused on measuring Omega-3, Athletes, Sports injuries, Inflammatory markers, Isokinetic muscle force

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wingate instituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 supplementation

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Tendon Structure
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

Inflammatory marker
Serum interleukin 6 (IL-6) (pg/mL)
Muscle Strength
Total work (Kjoule) (using Biodex isokinetic testing protocol)
Omega-3 status
Distribution (%) of 26 identified fatty acids - measured in Blood
Cross sectional area of Achilles tendon
measured using Ultrasound Tissue Characterization (UTC) (cm^2)
Range of motion - knee
using digital inclinometer for range of motion measurement (degrees)
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
functional assessment
VISA P questionnaire - scale 0-100
Pro-inflammatory cytokine.
Serum interleukin 17 (IL-17) (pg/mL)
Marker for inflammation
C Reactive Protein (CRP) (mg/L)

Full Information

First Posted
December 2, 2018
Last Updated
September 29, 2020
Sponsor
Meir Medical Center
Collaborators
University of Haifa, Tel Hai College
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1. Study Identification

Unique Protocol Identification Number
NCT03880149
Brief Title
The Effects of Omega-3 Status and Supplementation on Tendon Structure in Competitive Athletes
Official Title
The Effects of Omega-3 Status and Supplementation on Tendon Structure and Recovery From Sports Injuries in Competitive Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
Collaborators
University of Haifa, Tel Hai College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries, Inflammation
Keywords
Omega-3, Athletes, Sports injuries, Inflammatory markers, Isokinetic muscle force

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 supplementation
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
Medium-chain triglyceride (MCT) and vitamin E
Primary Outcome Measure Information:
Title
Tendon Structure
Description
Changes in the echo pattern of patellar and Achilles tendons structure using Ultrasound Tissue Characterization (UTC). Distribution (%) of echo type 1-3.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Inflammatory marker
Description
Serum interleukin 6 (IL-6) (pg/mL)
Time Frame
3 months
Title
Muscle Strength
Description
Total work (Kjoule) (using Biodex isokinetic testing protocol)
Time Frame
6 months
Title
Omega-3 status
Description
Distribution (%) of 26 identified fatty acids - measured in Blood
Time Frame
6 months
Title
Cross sectional area of Achilles tendon
Description
measured using Ultrasound Tissue Characterization (UTC) (cm^2)
Time Frame
6 months
Title
Range of motion - knee
Description
using digital inclinometer for range of motion measurement (degrees)
Time Frame
6 months
Title
Pain assessment
Description
pain severity using visual analog scale (VAS) - on a scale of 0 -10, 0 being no pain and 10 the worst pain ever
Time Frame
6 months
Title
functional assessment
Description
VISA P questionnaire - scale 0-100
Time Frame
3 months
Title
Pro-inflammatory cytokine.
Description
Serum interleukin 17 (IL-17) (pg/mL)
Time Frame
3 months
Title
Marker for inflammation
Description
C Reactive Protein (CRP) (mg/L)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Nemet, MD
Phone
972-9-7471640
Email
Dan.Nemet@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Pantanowitz, PhD
Phone
972-9-7471596
Email
michalmirochnik@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Organizational Affiliation
Meir Medical Center, Kfar-Saba, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Organizational Affiliation
University of Haifa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yitzhak Weinstein, PhD
Organizational Affiliation
Tel Hai Academic College
Official's Role
Study Director
Facility Information:
Facility Name
Wingate institute
City
Netanya
ZIP/Postal Code
4290200
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Phone
+972-9-7471596
Email
Dan.Nemet@clalit.org.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
27923448
Citation
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.
Results Reference
background
PubMed Identifier
29985775
Citation
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.
Results Reference
result
PubMed Identifier
26085822
Citation
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.
Results Reference
result
PubMed Identifier
25203220
Citation
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.
Results Reference
result

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

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