Sample collection for assessment of variability of metabolite and protein biomarkers in healthy male volunteers
- Conditions
- Explorative research for future use of specific biomarkers as endpoints in (pharmacological) intervention studies.NA
- Registration Number
- NL-OMON43491
- Lead Sponsor
- niversiteit Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1. Healthy male volunteers aged 18 to 45 years of Caucasian origin;
2. Body Mass Index (BMI) in the range of 20 to 30 kg/m²;
3. Normal results from standard laboratory examination;
4. Non-smoking;
5. Ability to communicate well with the investigator;
6. Volunteers must be able to give written informed consent and willing to comply with all study-related procedures.
1. Chronic illness, or any other clinically significant abnormality as determined by medical history taking and laboratory examination as obtained during the screening visit;
2. Any recent infectious disease;
3. Current use of any prescription drugs and OTC medications (including vitamins, minerals, herbals, dietary supplements);
4. Dietary restrictions, or following a diet to gain or lose weight, or a medically prescribed diet;
5. History of alcohol or drug abuse;
6. Any psychological or physical condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol;
7. A reported food allergy or sensitivity (wheat, milk, eggs, nuts, etc.);
8. Reported unexplained weight loss or weight gain of > 2 kg in the month prior to screening;
9. Donation of blood within 3 months prior to screening.
10. Participation in an investigational trial within 3 months prior to screening;
11. Not having a general practitioner.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The biological specimens collected in this study will be used for extensive<br /><br>proteomic and metabolomic analysis, and provide insight into the variability of<br /><br>an extensive set of biomarkers. The endpoints will comprise hundreds of<br /><br>metabolites and more than 1,300 different targeted proteins by proteomic<br /><br>analysis in blood and urine samples. Genetic information will not be collected<br /><br>in this study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>