Explorative research for future use of specific biomarkers as endpoints in (pharmacological) intervention studies. NA
Conditions
Interventions
None listed
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The biological specimens collected in this study will be used for extensive proteomic and metabolomic analysis, and provide insight into the variability of an extensive set of biomarkers. The endpoints will comprise hundreds of metabolites and more than 1,300 different targeted proteins by proteomic analysis in blood and urine samples. Genetic information will not be collected in this study. | — |
Countries
Netherlands
Outcome results
None listed