Status:
COMPLETED
Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
Phyco-Biotech
Conditions:
Elderly
Eligibility:
All Genders
60-75 years
Phase:
NA
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 centra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03464760
Start Date
January 22 2020
End Date
November 30 2022
Last Update
December 4 2025
Active Locations (1)
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1
CHU Nimes
Nîmes, France, 30029