Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Evotec International GmbH
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Complaints that may indicate the presence of an infection, including Covid-19. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of blood samples from healthy volunteers to serve as a healthy control group. | 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. | 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. |
Countries
Germany
Outcome results
None listed