healthy or diverse
Conditions
Interventions
Group 1: homogeneous group - healthy, young (reduced biological variability)
Group 2: heterogeneous - diverse, all ages (higher biological variability)
Sponsors
CBmed GmbH - Center for Biomarker Research in Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Subject Inclusion Criteria heterogeneous group 1. Signed informed consent before any trial-related activities 2. Male or female or transgender (any) 3. Age between 18 – 90 years (both inclusive) 4. Body mass index (BMI) above = 18.5 kg/m2 5. With at least one of any metabolism impacting specialty or medical condition such as (but not limited to): o Non-standard diet (e.g. vegan, raw, Atkins low carbohydrate, intermittent fasting, ketogenic…) o Non-Caucasian ethnicity o Age outside the range of homogenous group (outside 20-30) o Chronic metabolic disease (e.g. Diabetes, obesity) o Chronic autoimmune disease (e.g. systemic lupus erythema, rheumatoid diseases, multiple sclerosis) o Chronic lung disease (e.g. pulmonary hypertension, chronic obstructive lung disease) o Partial or total removal of organs (e.g. Hysterectomy, kidney donation, bariatric surgery) or transplant receiver o Substance abuse (e.g. alcohol, drug of abuse, smoking) o Digestive diseases or malabsorption necessitating specific diet (e.g. glu-ten-free, fructose-free, Morbus Crohn, Phenylketonuria) o Concomitant medication (e.g. heparin, nonsteroidal or steroidal anti-inflammatory drugs, corticosteroids, growth hormones, antihistamines or selective serotonin reuptake inhibitors) o Women in midst of their menopause o Acute disease (e.g. common cold, light fever, recuperating from a bone fracture or surgery) o Hormonal contraception (e.g. oral, coil, Implanon, 3 month injection) o As judged by the investigator and accordingly noted in the SDF Gender distribution within the group should be approximately balanced, i.e. each should be between 40-60% of total group size: 12-18 female, 12-18 male. Subject Inclusion Criteria homogeneous group 1. Signed informed consent before any trial-related activities 2. Male or female 3. Age between 20 – 30 years (both inclusive) 4. Body mass index (BMI) between18.5 – 25 kg/m2(both inclusive) 5. Ethnicity Caucasian 6. Drug of abuse abstinent (for >1 year pre-trial) 7. Non-smoker or light smoker (=1 cigarette/week) 8. Abstinent or only light alcohol consumption (=7 units/week, 1 unit = 10 ml or 8 g alcohol)
Exclusion criteria
Exclusion criteria: Subject Exclusion Criteria heterogeneous group 1. Severe acute, or severe chronic diseases or any other condition which at the investigator’s judgement would interfere with the safety of the subject or with the study results 2. Known anaemia, blood or plasma donation within the last month 3. Pregnancy, breastfeeding, intention of becoming pregnant or not using ade-quate contraception 4. Mental incapacity, unwillingness or language barriers precluding adequate un-derstanding or co-operation Subject Exclusion Criteria homogeneous group 1. Any acute or chronic diseases or any other condition which at the investigator’s judgement would interfere with the safety of the subject or with the study results 2. Known anaemia, blood or plasma donation within the last month 3. Pregnancy, breastfeeding, intention of becoming pregnant or not using ade-quate contraception 4. Hormonal contraception (e.g. oral, coil, Implanon, 3 month injection) 5. Intake of medication with heparin, nonsteroidal or steroidal anti-inflammatory drugs within the last 10 days, and medication with antihistamines or selective serotonin reuptake inhibitors within the last 4 weeks, in vitro fertilization (IVF) treatment in the last 3 months 6. Surgery within the last 3 months 7. Non-standard diet (e.g. vegan, vegetarian, gluten-free, malabsorption specific diets, atkins, raw, intermittent-fasting, ketogenic…) 8. Mental incapacity, unwillingness or language barriers precluding adequate un-derstanding or co-operation Gender distribution within the group should be approximately balanced, i.e. each should be between 40-60% of total group size: 8-12 female, 8-12 male. 8.6 2nd Study Visit – Exclusion Criteria only for homogenous group 1. Any acute or chronic diseases or any other condition which at the investigator’s judgement would interfere with the safety of the subject or with the study results 2. No overnight fast (12 h, last meal 18:00 of the previous day) 3. Intensive physical activity (>30 min with pulse >120 or sweating for >15 min) in the last 24 h 4. Consumed alcohol/smoking in the last 24 h 5. Result of alcohol breath test = 0 ‰ 6. Consumed drugs of abuse since 1st Visit 7. Intake of any medication since 1st Visit 8. Abnormal body temperature (outside of 35.9–37.6°C) Subjects not compliant with the instructions for the 2nd visit (fasting, abstinence) can be rescheduled within up to three weeks if compliance is foreseeable, possible and likely. Subjects excluded from the homogenous group according to criteria which are unlikely to be compliant even after a reschedule can be reassigned to the heterogeneous group if compliant to those in-/exclusion criteria.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| A. To reliably detect various extents of centrifugation delay, correla-tions of observed spectral differences between delayed vs. imme-diately centrifuged samples will be investigated for linear and non-linear correlation. Reliable detection is achieved with a classifica-tion in at least three time bands with a sensitivity of = 0.8 and speci-ficity of = 0.6 (or vice versa) or a prediction of the delay time with an accuracy and precision of approximately 30 min. • Results from NEM stabilized tubes will deliver initial amounts of metabolites with oxidation sensitive thiol groups allowing improved correlation of time delay versus spectral differences with time dependency B. The performance of detected sample quality biomarkers or bi-omarker patterns will be investigated and compared to results from standard clinical laboratory sample quality measurements. Medical data from subjects will be collected in order to increase the ro-bustness of biomarkers against the possible biological variability of blood sample compositions. The collection is placing an emphasis on factors known from literature to influence metabolome and/or proteome profiles. | — |
Primary
| Measure | Time frame |
|---|---|
| In order to achieve the primary objective, PESI-MS spectral differences from optimally handled samples vs. samples with delayed centrifugation will be obtained by means of single peak and full spectra (fingerprint) ap-proaches. The performance of sample quality biomarkers or biomarker pattern based on these spectral differences will be tested. Reliable detec-tion of a delay of =3 h versus immediate centrifugation of blood samples for plasma preparation is defined here as achieving an area under the curve (AUC) =0.85 in a receiver operator characteristic (ROC). | — |
Countries
Austria
Contacts
Public ContactEva Svehlikova
Clinical Research Center (CRC)Medizinische Universität Graz
Outcome results
None listed