To study the variation of biological age within and between different chronological age categories using forced expiratory volume in 1 second (FEV1), systolic blood pressure, clinical chemistry and epigenetic tests in blood samples of healthy…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Explorative research on age related disease specific biomarkers as endpoints in (pharmacological) intervention studies.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The incidence of age-related disease like Alzheimer*s disease, prostate cancer
and cardiovascular diseases increases significantly with age and therefore
aging is an important factor when studying these diseases. In future studies,
the Janssen Prevention Center of Crucell Holland BV, part of the Janssen
Pharmaceutical Companies of Johnson & Johnson, herein forth mentioned as the
Janssen Prevention Center intends to study the variation of biological age in
relation to disease-specific markers for the estimation of disease risk.
Study objective
To study the variation of biological age within and between different
chronological age categories using forced expiratory volume in 1 second (FEV1),
systolic blood pressure, clinical chemistry and epigenetic tests in blood
samples of healthy subjects.
Study design
This is an exploratory cross-sectional study which will be executed at the
Centre for Human Drug Research (CHDR) in Leiden. A total of 60 healthy
volunteers will participate: 20 subjects aged between 20 and 30 years, 20
subjects aged between 40 and 50 years and 20 subjects aged between 60 and 70
years. Of the participating subjects 50% needs to be women and 50% men within
each age category
Study burden and risks
This study requires physical examination, vital signs, FEV1, and collection of
blood and urine samples. The burden for the volunteer related to the study
procedures is limited. All collections will be performed in a state of the art
clinical unit and medically supervised by qualified medical staff.
Archimedesweg 4-6
Leiden 2333 CN
NL
Archimedesweg 4-6
Leiden 2333 CN
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57181.056.16 |