Blood and Urine Sample Collection From Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-05-27

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hanna Peradziryi

Role: STUDY_CHAIR

[email protected]

Locations

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CTC North

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EVT_CTC_01

Identifier Type: -

Identifier Source: org_study_id