Blood and Urine Sample Collection From Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Collection of blood samples from healthy volunteers to serve as a healthy control group.
研究概览
简要总结
The aim of the study is to obtain blood and urine samples from healthy volunteers to serve as a healthy control group for cross-cohort comparisons.
详细描述
The aim of the study is to obtain peripheral venous blood samples and a urine sample from 100 healthy volunteers on one day at three different times of the day, to serve as a healthy control group for cross-cohort comparisons.
With the help of the urine and blood samples obtained in this context, a cohort of a healthy collective is to be established for further research purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 40-70 years.
- •Caucasian
- •Non-smokers or ex-smokers
- •Body Mass Index (BMI): ≥18.5 and ≤32 kg/m2
- •Presence of a negative SARS-CoV-2 PCR test.
排除标准
- •Complaints that may indicate the presence of an infection, including Covid-
- •Pathological alcohol consumption.
- •Positive alcohol breath test at the preliminary examination.
- •Alcohol consumption within the last 24 hours before the start of sampling.
- •History of drug dependence.
- •Positive urine drug test during the preliminary examination.
- •Clinically significant acute or chronic disease. In particular, chronic inflammation, rheumatological and other autoimmune diseases, diabetes and other metabolic diseases.
- •Indications in the medical history or during the medical examination that may jeopardize the safety of the study participant by participating in the study.
- •History of relevant clinically significant cardiovascular disorders or clinically relevant hyper- or hypotension or clinically relevant brady- or tachycardia at screening as assessed by an investigator.
- •Heart rate <45/min after 5 minutes in a quiet sitting position.
- •Heart rate >100/min after 5 minutes in a quiet sitting position.
- •Systolic blood pressure of > 170 mmHg or < 90 mmHg.
- •Diastolic blood pressure of > 95 mmHg and/or < 60 mmHg.
- •Regular use of prescription medication within 3 months prior to inclusion in the research project.
- •Use of non-prescription medications within 3 days prior to inclusion in the research project.
- •Presence of clinically significant food intolerance and/or food allergy as assessed by the investigator.
- •Medically relevant previous operations.
- •Condition following radio- or chemotherapy.
- •History of oncological diseases.
- •Blood and/or plasma donation within the last 30 days prior to sample collection.
- •Pregnant or nursing female.
- •Employees of study site.
结局指标
主要结局
Collection of blood samples from healthy volunteers to serve as a healthy control group.
时间窗: 1 day
There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the blood samples as a control group.
Collection of urine samples from healthy volunteers to serve as a healthy control group.
时间窗: 1 day
There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the urine samples as a control group.
次要结局
未报告次要终点