An interventional study of Omega-3 and Placebo in Tendon Injuries and Inflammation, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Other
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.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 140 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Part one:
Part two:
Exclusion Criteria:
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
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
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
Medium-chain triglyceride (MCT) and vitamin E
Tendon Structure
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
Inflammatory marker
Serum interleukin 6 (IL-6) (pg/mL)
Time frame: 3 months
Muscle Strength
Total work (Kjoule) (using Biodex isokinetic testing protocol)
Time frame: 6 months
Omega-3 status
Distribution (%) of 26 identified fatty acids - measured in Blood
Time frame: 6 months
Cross sectional area of Achilles tendon
measured using Ultrasound Tissue Characterization (UTC) (cm\^2)
Time frame: 6 months
Range of motion - knee
using digital inclinometer for range of motion measurement (degrees)
Time frame: 6 months
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
Time frame: 6 months
functional assessment
VISA P questionnaire - scale 0-100
Time frame: 3 months
Pro-inflammatory cytokine.
Serum interleukin 17 (IL-17) (pg/mL)
Time frame: 3 months
Marker for inflammation
C Reactive Protein (CRP) (mg/L)
Time frame: 3 months
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Meir Medical Center