healthy subjects
Conditions
Interventions
Group 1: Observational study with a single measurement time point (cross-sectional analysis). The study investigates biophysical markers of blood cells (including deformability, size, circumference, p
Sponsors
Institute of Food and One Health, Leibniz Universität Hannover
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Capable of giving informed consent, healthy men and women aged 18–75 years Written informed consent after detailed written information regarding the content, requirements, and risks of the study German-speaking individuals
Exclusion criteria
Exclusion criteria: Serious medical conditions (e.g. tumours, myocardial infarction, renal failure, liver cirrhosis, non-alcoholic fatty liver disease) Serious hematological diseases, in particular hereditary hemolytic anemias/hemoglobinopathies (e.g. sickle cell disease, thalassemias, hereditary spherocytosis/elliptocytosis); additionally exclusion of acute or chronic thrombotic microangiopathies (e.g. TTP) Reproductive status: pregnancy, breastfeeding, or intention to become pregnant during the study Blood donation: no blood donation within the last 3 months Acute infectious diseases Acute allergic symptoms or conditions Medication use: chronic use of corticosteroids, immunosuppressants, anticoagulants (except acetylsalicylic acid [aspirin]) and/or antiplatelet agents Alcohol or drug abuse Dietary changes: current energy-restricted diets Study participation: concurrent participation in another clinical study or within the last 2 months prior to study start Active smoking (tobacco use)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biophysical markers of blood cells (including deformability, size, circumference, porosity, moment of inertia, and cell membrane stability) In the context of this exploratory cross-sectional study, no single primary endpoint can be defined at this time. The aim of the study is to generate hypotheses, not to test a specific, predefined hypothesis. To date, there is no established scientific basis for prioritizing a single biophysical cell marker as the primary endpoint, and different cell types may also exhibit different response patterns. Therefore, in this study, several biophysical parameters are considered as equally important exploratory endpoints and must be evaluated using multivariate analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete blood count (including derived parameters: neutrophil-to-lymphocyte ratio [NLR], systemic inflammatory index [SII], low-grade inflammation score [INFLA], red cell distribution width [RDW]) C-reactive protein (CRP), cytokines (interleukin-6, interleukin-1 beta, TNF-a) Fibrinogen Serum lipids (triglycerides [TG], LDL, HDL, total cholesterol) Parameters of glucose metabolism (glucose, insulin, HbA1c, HOMA index) Biomarkers of nutritional status: 25-hydroxyvitamin D, RBC fatty acid profile including omega-3 index, erythrocyte folate (RBC folate), holotranscobalamin (holo-TC) + methylmalonic acid (MMA) + homocysteine (Hcy), ferritin, transferrin, serum iron | — |
Countries
Germany
Contacts
Public ContactAndreas Hahn
Institute of Food and One Health, Leibniz Universität Hannover
Outcome results
None listed