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

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

Study Contact Backup

Study Locations

      • Netanya, Israel, 4290200

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.

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.

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

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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