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临床试验/NCT05562232
NCT05562232招募中不适用

The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms - a Pilot Study Protocol

Psychiatric Research Unit, Region Zealand, Denmark2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
45
试验地点
2
主要终点
Change from Baseline Post-Concussion Symptoms at 7 weeks

研究概览

简要总结

The purpose of this study, is to investigate whether creatine monohydrate as a supplement reduces the number and severity of symptoms in patients with persistent post-concussive symptoms through self-reported post-concussion symptoms questionnaires.

详细描述

Mild traumatic brain injury (mTBI), which throughout the literature is used interchangeably with concussion, is a problem of public concern. It is estimated that between 0.6 % and 1.2 % of the general population will suffer an mTBI each year which equals to 48-96 millions of people on a world scale. Out of these, an estimated 10-30 % of the patients, will suffer from persistent PPCS. These symptoms typically includes headache, poor concentration, memory problems, fatigue, sleep difficulties, dizziness, irritability, feeling nervous or anxious. PPCS has proven to be not only a health problem, but also a socioeconomical problem. Data has showed that salary in Denmark five years after a concussion decreased 4.2 %, with an increased risk of losing ones job. At the moment no single treatment option is available with guaranteed success, and therefore nutritional supplements are a possibility.

The nutritional supplement CrM is one of the most popular ergogenic aids on the market among professional and amateur athletes. It is mostly used in the development of muscle mass, as creatine is primarily located skeletal muscle. Roughly five percent of the body's creatine is distributed in the brain and testicles. As mTBI's also see a change in the metabolism of the brain, creatine supplementation might be beneficial for patients with PPCS. This is further supported by a newly conducted study, that creatine supplementation may reduce the severity of mild concussion in animal models.

Furthermore, as the enzyme Creatine Kinease (CK), which is involved in ATP energy system, also has a brain specific isoform (BB-CK), creatine may be a relevant part of the energy system of the central nervous system (CNS). In addition evidence points towards creatine supplementation can increase cellular energy availability. It has been reported to increase brain phosphocreatine content by as much as 15 %, which in turn improves the metabolic processes of the brain.

CrM has been described to be a potent anti-inflammatory molecule. It has been shown to reduce the cytotoxic effects in oxidatively-injured cells without affecting antioxidant enzyme activities, and has been shown to inhibit reactive oxygen species-induced formation of mitochondrial permeability transition pores in the liver mitochondria of mice. At the same time, concussion seems to increase inflammation in the brain, and this inflammation has been hypothesized to correlate with the symptomatology and duration. And even though research in the area of recovery is still scarce, neuroinflammation seems to play a vital role in the pathophysiology of concussions. This warrants hopes of a decrease in post-concussive symptoms.

Other studies have indicated an improvement of cognitive functions, including fatigue, working memory and mood state. All symptoms related to PPCS. Additionally evidence points towards creatine supplementation can help with chronic fatigue, depression and anxiety. All this points towards CrM being helpful in the treatment of PPCS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Have had PPCS for a minimum of six months and a maximum of 18 months at the start of the study.
  • Being between 20 and 45 years of age

排除标准

  • Elite athletes, as well as people who in general is physical active, at an intensity of moderat to high, for more than ten hours a week on average.
  • Participation in other interventions/treatment that could affect this study
  • Have had PPCS in:
  • =<6 months
  • =>18 months

结局指标

主要结局

Change from Baseline Post-Concussion Symptoms at 7 weeks

时间窗: Baseline, 3 weeks and 7 weeks (follow-up)

Rivermead Post-Concussion Symptom Questionnaire

次要结局

  • Change from Baseline Body weight at 7 weeks(Baseline, 3 weeks and 7 weeks (follow-up))

研究者

发起方
Psychiatric Research Unit, Region Zealand, Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Haurum Marcussen

Dr.

Psychiatric Research Unit, Region Zealand, Denmark

研究点 (2)

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