Investigation of Safety of WS®1442 in Slightly Overweight Subjects With Pilot Assessment of Pharmacodynamic Effects of WS®1442 on Endothelial Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lab parameters
研究概览
简要总结
The purpose of this study is to test:
- Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²)
- Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects
详细描述
60 overweight subjects with a BMI of 25 to 29,9 kg/m2 are to be included. The safety of 900 mg/1800 mg per day WS® 1442 is determined by adverse events, laboratory parameters, vital signs as well as by a treadmill test at the beginning and the end of the study. Endothelial function measured before and after two different training modalities is compared to that measured before and after intake of two different doses of WS® 1442.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •male and female subjects aged 45-75 years
- •untrained
- •BMI between 25 and 29,9 kg/m²
- •resting blood pressure in sitting position ≤ 140/90 mmHg
- •inconspicuous ergometry
排除标准
- •pregnancy or breastfeeding
- •any other current medication
- •intake of other hawthorn preparation or dietary supplements with possible influence on the interpretation of study results
- •any known diseases
- •alcohol or drug abuse/addiction
- •nicotine abuse
- •any known hypersensitivity to any of the ingredients of the investigated drug
- •inability or inadequate ability to write or speak German
- •not-postmenopausal women: positive pregnancy test or unsafe contraception
- •any urinary test finding requiring diagnostic assessment or treatment
- •deformation of the 2nd to 5th finger of both hands preventing an adequate measurement of endothelial function
研究组 & 干预措施
WS® 1442 900 mg
干预措施: WS® 1442 900 mg/d (Drug)
WS® 1442 1800 mg
干预措施: WS® 1442 1800 mg/d (Drug)
Nordic walking training 2x30 min
干预措施: Nordic walking training 2 x 30 min/week (Behavioral)
Nordic walking training 4x45 min
干预措施: Nordic walking training 4x45 min/week (Behavioral)
结局指标
主要结局
Lab parameters
时间窗: 12 weeks
Vital signs
时间窗: 12 weeks
Treadmill test including lactate measurement
时间窗: 12 weeks
Adverse events
时间窗: 12 weeks
次要结局
- Endothelial function(12 weeks)