blood pressure capillary density microcirculation sodium Th17 cells
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Male between 18 and 40 years of age - Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination (PE) and laboratory tests carried out in the screening visit. - Non-treated office blood pressure
Exclusion criteria
Exclusion criteria: - An office blood pressure >130/85 mmHg - A body mass index > 30 kg/m2 - A major illness in the past 3 months or any significant chronic medical illness that the Investigator would deem unfavourable for enrolment, including chronic inflammatory diseases - A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell cancer of the skin - A history of any renal disease - A history of any auto-immune disease - A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction, (un-)stable angina pectoris or acute coronary syndrome, precutenaous transluminal coronary angioplasty, coronary artery bypass grafting, cerebrovascular disease including ischemic and hemorrhagic stroke or a subarachnodial bleeding, or peripheral artery disease including aortic aneurysmata - A history of eye-surgery, glaucoma or retinal eye disorder - A history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC, methamphetamine) - A history of alcoholism and/or drinking more than 3 units of alcohol per day. Alcoholism is defined as an average weekly intake of >21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits - Smoking or use of tobacco products less then 30 days ago - Any other issue that in opinion of the Investigator could be harmful to the subject or compromise interpretation of data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Several primary endpoints are proposed. 1. Microcirculation A. To assess the effect of dietary sodium intake on capillary recruitment and capillary perfusion determined by capillary density, proportion of perfused density, microculatory flow index and tortuosity, assessed by SDF-imaging, nailfold capillaroscopy and retinal vascular imaging. B. To assess whether high sodium-induced changes in microcirculation can be restored by nitroglycerin, being a NO donor to the capillary vessel bed. 2. Immune system A. To assess whether different sodium intakes (high or low salt diet) will lead to changes in circulating T-lymphocyte subpopulations (e.g., Th17 cells). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Microcirculation C. To assess if microcirculatory changes in response to dietary sodium are related to macrocirculatory changes, displayed by measurement of central and peripheral blood pressure by use of continuous finger arterial pressure (FinAp) waveform registration with the semi-automatic device Nexfin® and by using radial pulse waveforms with the semi-automatic device Sphygmocor®. 3. Other A. To assess whether different sodium intakes will lead to changes in eNOS and RNA expression and sulfation of glycosaminoglycans (GAGs) of the skin. This study is in line with other studies of our group studying the influence of dietary salt intake (SALT and SALT-2 study). Due to used storage conditions with formalin, techniques such as mass spectrometry, PCR or western blot are not possible to perform on skin biopsies collected in the SALT studies. Therefore we would like to use skin biopsies of this study in order to perform these techniques. The skin biopsies derived from the SALT-studies will be used to relate the effects of sodium intake on T-cell subpopulations, as part of the current protocol, to influx of inflammatory cells into the skin (macrophages and T-cells). | — |
Countries
Netherlands