The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers and Coagulation After Marathon Running
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running
研究概览
简要总结
The aim of the present study is to investigate changes in inflammatory status and incidence of infection after extreme aerobic physical stress (participation in a marathon). In addition, the impact of marathon running on the hemostasis and muscular state will be evaluated. Changes at the inflammatory, muscular, and rheological level will be related to ingestion of oral hydrolytic enzymes and bioflavonoids.
详细描述
The influence of extreme physical stress, such as that experienced during marathon competition, on the inflammatory system and coagulation has been investigated. However, up until now, countermeasures against these adverse effects are not adequately identified.
Immune-modulators (e.g. flavonoids) are known to be present in fruits and vegetables. There are also several different proteolytic and hydrolytic enzymes found in fruits most of whom are attributed protective properties. Therefore, 160 trained and untrained runners will consume a mixture of different enzymes and flavonoids (Wobenzym Plus®) or PL 1 (placebo) and effects on changes in inflammation and hemostasiologic parameters will be investigated during and after extreme physical stress (participation in a marathon race). The clinical result of the perturbation of the immune system will be assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) with regard to symptoms of the upper respiratory tract system.
It is hypothesized that the intake of a product with immunomodulatory potential (Wobenzym Plus ®, consisting of hydrolytic enzymes and flavonoids) can positively influence both inflammation and blood coagulation pertubations observed after a marathon race.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •• Healthy male
- •Age 20-65 years
- •History of at least one successfully finished half marathon
- •Intention to participate at the Munich Marathon 2013
- •Subject is able to read, understand, and sign a written Informed Consent to participate in the Enzy-MagIC-Study
排除标准
- •Known cardiac disease
- •Known allergy against the active ingredient of the study medication or pineapple, papaya, or kiwi
- •Known severe coagulopathy
- •Known lactose intolerance
- •Pharmaceutical treatment for diabetes mellitus or arterial hypertension
- •Acute or chronic renal failure
- •Acute or chronic liver disease
- •Acute or chronic infection or inflammatory disease
- •Use of medications or supplements influencing immune function
- •Musculoskeletal or psychiatric disease
- •Neoplasia
- •Participation in other interventional trials
研究组 & 干预措施
Wobenzym plus
3 x 4 tablets of the study medication each day for the one week before and 3 x 2 tablets of the study medication each day for the two weeks after the marathon.
干预措施: Wobenzym plus (Drug)
Placebo PL1
3 x 4 tablets of the study medication each day for the one week before and 3 x 2 tablets of the study medication each day for the two weeks after the marathon.
干预措施: PL 1 (Drug)
结局指标
主要结局
The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Inflammatory Markers after Marathon Running
时间窗: one months
Change of the inflammatory marker (IL-6) before and after a marathon in relation to the consumption of oral hydrolytic enzymes and bioflavonoids.
次要结局
- The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on upper respiratory tract infections after Marathon Running(one months)
- The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on Coagulation after Marathon Running(1 month)
- The Effects of Oral Proteolytic and Hydrolytic Enzymes and Flavonoids on muscular strain after Marathon Running(1 month)