Elderly
Conditions
Brief summary
The investigators hypothesize that spirulina-silicon supplementation will lead to an improvement in vasomotor endothelial function, followed by decreased arterial wave velocity on the aorta and central arterial pressure compared to placebo subjects.
Interventions
DIETARY_SUPPLEMENT3.5g of spirulina per day in 1% silicone
5 tablets of 700mg per day
DIETARY_SUPPLEMENTplacebo
5 tablets per day of potato-based placebo
Sponsors
Phyco-Biotech
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject must have given their free and informed consent and signed the consent form * The subject must be a member or beneficiary of a health insurance plan * The subject is available for 6 months of follow-up * The subject must not have any pre-existing chronic illness nor any revealed during the pre-inclusion visit, either treated or requiring treatment according to current recommendations
Exclusion criteria
* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Presence of a chronic cardio-vascular and/or metabolic illness, known or revealed by the pre-inclusion exam and requiring treatment in accordance to official recommendations (HAS) * Any other chronic pathology requiring medical treatment * History of uric acid metabolism disorders (hyperuricemia, gout, urolithiasis). * Subject presenting a loss of limitation of autonomy * Treated with hormone replacement therapy in females * Active smoker or drug user * Presence of an abnormality revealed by the pre-inclusion biological assessment of dyslipidemia justifying a prescription medication, diabetes or intolerance to glucose (insulin resistance). * Presence of a stenosis (greater than 50% in diameter, NASCET method) or carotid occlusion revealed by the echo-Doppler screening test. * Presence of an aneurysm (dilation\> 30 mm) of the abdominal aorta revealed by the echo-Doppler screening test. * Arteriopathy of the lower limbs (toe systolic pressure (tsp) \<0.7) revealed by the screening test (SysToe™ device). * Subject already taking a food supplement based on spirulina or silicon. * History of cardio-vascular disease or heart attack * Subject develops a chronic illness requiring medical treatment for more than 7 days or a surgical intervention leading to incapacity for more than 7 days,or a pathological event during the 14-day period before each follow-up visit, or a serious adverse event
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Pressure Waveforms between groups | Month 6 | Applanation tonometry; m.s-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vasomotor endothelial function between groups | Day 0 | % post-ischemic vasorelaxation |
| intima-media thickness of common carotid arteries | Day 0 | echography; mm |
| left ventricular diastolic function | Day 0 | kPa |
| Central venous pressure | Day 0 | mmHg |
| Arterial Pressure Waveforms between groups | Day 0 | Applanation tonometry; mm |
| Vasomotor endothelial function of females compared to males | Month 6 | % post-ischemic vasorelaxation |
| Bone density | Day 0 | dual-photon absorptiometry |
| Biological markers of vascular remodeling, oxidative stress and inflammation | Day 0 | Total cholesterol, High density lipoproteins, Triglycerides, Complete Blood Count, high-sensitivity C-reactive protein, toe systolic pressure, Oxidized low density lipoprotein, Vitamin E, Vitamin C, Reduced (GSH) and Oxidized (GSSG) Glutathione ratio, Procollagen type I N propeptide, cross-linking telopeptide of type I collagen, Elastin, Osteoprotegerin, Sclerotin, Calcium, Phosphorus, Alkaline Bone Phosphatase |
| Arterial Pressure Waveforms of females compared to males | Month 6 | Applanation tonometry; m.s-1 |
Countries
France
Outcome results
None listed