Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly (ANGIO SPIRUL)

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Elderly

Treatments

Dietary Supplement: 3.5g of spirulina per day in 1% silicone

Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03464760

LOCAL/2016/APM-01

2017-A00981-52 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

60 to 75 years old

Volunteers

Accepts Healthy Volunteers

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