NCT03880149

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

December 2, 2018

Last Update Submit

September 29, 2020

Conditions

Tendon InjuriesInflammation

Keywords

Omega-3AthletesSports injuriesInflammatory markersIsokinetic muscle force

Outcome Measures

Primary Outcomes (1)

  • Tendon Structure

    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 Outcomes (9)

  • Inflammatory marker

    3 months

  • Muscle Strength

    6 months

  • Omega-3 status

    6 months

  • Cross sectional area of Achilles tendon

    6 months

  • Range of motion - knee

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Omega-3 supplementation

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Omega-3DIETARY_SUPPLEMENT

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

Omega-3 supplementation
PlaceboOTHER

Medium-chain triglyceride (MCT) and vitamin E

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Underwent lower extremities surgeries.
  • Allergic to Fish products.
  • Athletes who use anti-inflammatory drugs and/or omega-3 supplements.
  • Pregnant and/or nursing mothers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate institute

Netanya, 4290200, Israel

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27923448BACKGROUND

  • 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.

    PMID: 29985775RESULT

  • 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.

    PMID: 26085822RESULT

  • 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.

    PMID: 25203220RESULT

MeSH Terms

Conditions

Tendon InjuriesInflammationAthletic Injuries

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Dan Nemet, MD

    Meir Medical Center, Kfar-Saba, Israel

    PRINCIPAL INVESTIGATOR

  • Gali Dar, PhD

    University of Haifa

    STUDY DIRECTOR

  • Yitzhak Weinstein, PhD

    Tel Hai Academic College

    STUDY DIRECTOR

Central Study Contacts

Dan Nemet, MD

CONTACT

972-9-7471640Dan.Nemet@clalit.org.il

Michal Pantanowitz, PhD

CONTACT

972-9-7471596michalmirochnik@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics. Director, Child Health and Sports Center

Study Record Dates

First Submitted

December 2, 2018

First Posted

March 19, 2019

Study Start

February 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

October 1, 2020

Record last verified: 2020-09

Locations

IL(1)