Explorative research on age related disease specific biomarkers as endpoints in (pharmacological) intervention studies. Biological age Biomarker profiling
Conditions
Interventions
None listed
Sponsors
Janssen Prevention Center
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Healthy male and female volunteers aged 20 * 30 years (including 30), or 40 * 50 (including 50), or 60 * 70 (including 70). Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical history and a complete physical examination including urinalysis. 2. Body Mass Index (BMI) below 30 kg/m². 3. Ability to communicate well with the investigator in the Dutch language. 4. Able to give written informed consent and willing to comply with all study-related procedures, and have signed an informed consent prior to any study-mandated procedure.
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria on the study day:;1. Are pregnant (positive pregnancy test) or lactating. 2. Taking any prescription drugs within 14 days of the study day or within 5 times the elimination half-life of the medication (whichever is longer), except female subjects who use contraceptives. Occasional acetaminophen/paracetamol is allowed. Exceptions may apply when, judged by the investigator, use of concomitant medication does not interfere with the study objectives. 3. Currently have, or have history of, clinically significant pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal or genitourinary disease or cancer. 4. Have had significant acute infection within two weeks of the study day. 5. Positive test for drugs of abuse and/or positive alcohol test on the study day . 6. Have a history of alcohol and/or drug abuse. 7. Smoking more than 5 cigarettes or equivalent per day in the past 6 months prior to the study day and unable to abstain from smoking whilst in the unit. 8. Donation or loss of blood over 500 mL within three months (males) or four months (females) days prior to the study day. 9. Have any dermatological condition (including eczema, skin disease at vein puncture site, keloids or scarring) that, in the opinion of the investigator, could increase the risk of adverse events to the volunteer from the sampling procedure. 10. Participation in a clinical trial within 90 days of the study day or more than 4 times in the previous year. 11. Have had prior unforeseen (serious) adverse reactions to blood donation including fainting, angina, severe bruising, scarring, allergic reactions, or any other adverse events. 12. Not having a general practitioner. 13. Have any physical or psychological medical condition which, in the opinion of the investigator, would be a contraindication to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The biological age will be estimated across different chronological age categories using biological age parameters including FEV1, systolic blood pressure, clinical chemistry parameters and epigenetic tests. For all clinical chemistry parameters (except glycated haemoglobin), different sample matrices (frozen serum versus frozen plasma) will be obtained and results will be compared. For some of these parameters, different laboratories will be compared. Overall the following aging parameters will be analysed: 1. Physical parameters: FEV1 and systolic blood pressure. 2. Clinical chemistry: total cholesterol, C-reactive protein (CRP), cytomegalovirus IgG, creatinine, urea nitrogen, alkaline phosphatase, albumin, glycated haemoglobin, alpha-1-acid glycoprotein, citrate, ceruloplasmin, haptoglobin, alpha-1-antitrypsin, IL-6,IL-18, IL-1*, TNF*, IGF-1, estradiol and dehydroepiandrosterone (DHEAS). 3. Epigenetic markers: DNA methylation age and aging-related microRNAs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remaining blood samples may be used for disease-specific markers and exploratory analyses. Disease-specific markers for Alzheimer*s disease may include: total concentration of anti-(phospho-)tau antibodies, (phospho-)tau concentration, *-amyloid concentration, Herpes Simplex Virus IgG and IgM and Alzheimer*s disease-related microRNAs. Exploratory analyses may include: additional aging parameters (e.g. telomere length, transcriptomic age, other aging and/or tissue-related differential DNA methylation, other aging-related differentially expressed (non-coding) RNAs including microRNAs, other acute phase proteins, VLDL particle size and other metabolomics parameters), other disease*specific parameters (e.g. cardiovascular biomarkers), long-term sample stability testing (up to 15 years) or bridging to state of the art methodologies. Determination of additional parameters in already collected materials, which are in agreement with the study objectives and do not provide prognostic or genetic information, will be communicated with the Ethics Committee by means of a non-substantial amendment. | — |
Countries
Netherlands
Outcome results
None listed