跳至主要内容
临床试验/NCT03880149
NCT03880149Unknown不适用

The Effects of Omega-3 Status and Supplementation on Tendon Structure and Recovery From Sports Injuries in Competitive Athletes

Meir Medical Center2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
2
主要终点
Tendon Structure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Training for at least 5 hours per week.
  • No complaints about lower extremities pains during the last 12 months.
  • Training for at least 5 hours per week.
  • Diagnosed with patellar and Achilles tendinitis.

排除标准

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

结局指标

主要结局

Tendon Structure

时间窗: 6 months

Changes in the echo pattern of patellar and Achilles tendons structure using Ultrasound Tissue Characterization (UTC). Distribution (%) of echo type 1-3.

次要结局

  • functional assessment(3 months)
  • Pro-inflammatory cytokine.(3 months)
  • Inflammatory marker(3 months)
  • Marker for inflammation(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)
  • Pain assessment(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Nemet, MD

Professor of Pediatrics. Director, Child Health and Sports Center

Meir Medical Center

研究点 (2)

Loading locations...

相似试验