The Dynamics Study: Influence of NaCl intake on Microcirculation and Immune sytem

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

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 <= 130/85 mmHg
- A body mass index <= 30 kg/m2
- Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Several primary endpoints are proposed.<br /><br><br /><br>1. Microcirculation<br /><br>A. To assess the effect of dietary sodium intake on capillary recruitment and<br /><br>capillary perfusion determined by capillary density, proportion of perfused<br /><br>density, microculatory flow index and tortuosity, assessed by SDF-imaging,<br /><br>nailfold capillaroscopy and retinal vascular imaging.<br /><br>B. To assess whether high sodium-induced changes in microcirculation can be<br /><br>restored by nitroglycerin, being a NO donor to the capillary vessel bed.<br /><br><br /><br>2. Immune system<br /><br>A. To assess whether different sodium intakes (high or low salt diet) will lead<br /><br>to changes in circulating T-lymphocyte subpopulations (e.g., Th17 cells).</p><br>

Secondary Outcome Measures