Effects of Recoverben® on Recovery After Exhaustive Exercise in Healthy People - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of muscle soreness (VAS) over time
研究概览
简要总结
The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.
详细描述
The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.
Targeted parameter will be determined at the beginning of the study and after supplementation, each. Parameter include maximal strength (MVC), muscle soreness (VAS), pain sensitivity (Algometry) and biomarkers (CK, IL-6, glutathione peroxidase).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- •Health volunteers: Subject is in good physical and mental health as established by medical his-tory, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
- •Men and women
- •Age ≥ 22 and ≤ 50 years
- •BMI: 19-30 kg/m2
- •Physically active 1-3 times per week
- •Nonsmoker
- •Able and willing to follow the study protocol procedures
排除标准
- •Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or anti-oxidative drugs or supplements, antihyper-tensive drugs) potentially interfering with this study at screening.
- •For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
- •Diabetes or serious cardiovascular diseases
- •Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))
- •Diet high in vegetables and fruits ≥ 5 portions per day
- •Participants anticipating a change in their lifestyle or physical activity levels during the study.
- •Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to visit 2 until visit
- •Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
- •Known hypersensitivity to the study preparation or to single ingredients
- •Pregnant subject or subject planning to become pregnant during the study; breast-
- •Known HIV-infection
- •Known acute or chronic hepatitis B and C infection
- •Blood donation within 4 weeks prior to visit 1 or during the study.
- •Subject involved in any clinical or food study within the preceding month
研究组 & 干预措施
Aloysia citriodora extract
Dietary Supplement: Aloysia citriodora extract
干预措施: Aloysia citriodora extract (Dietary Supplement)
Placebo Formulation
Dietary Supplement: Maltodextrin (no active ingredient)
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Change of muscle soreness (VAS) over time
时间窗: Chance over time after 10 days of supplementation (pre stress test and 3h, 24h, 48 h, 96h after stress test)
In the current study, pain following eccentric exercise will be assessed by using a 100 mm visual analogue scale after the subjects performing a standardized movement.
次要结局
- Change of pressure pain (Algometry) over time(Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test))
- Change of creatine kinase over time(Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test))
- Change of of glutathione peroxidase over time(Chance over time after 10 days of supplementation (pre stress test and 24h and 48 h after stress test))
- Change of interleukin-6 over time(Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test))
- Monitoring of related adverse events(During study execution over 15 days)
- Change of retrospective pain (Likert scale) over time(Chance over time after 10 days of supplementation (pre stress test and 24h, 48h, 96h after stress test))
- Change of maximal concentric strength/ maximal voluntary contraction (MVC) over time(Chance over time after 10 days of supplementation (pre stress test and 3h, 24h and 48 h after stress test))