Clinical trial NCT03464760: Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Official title: Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Phyco-Biotech
First posted: 2018-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Arterial Pressure Waveforms between groups
timeFrame: Month 6
Secondary outcomes:
measure: Arterial Pressure Waveforms between groups
timeFrame: Day 0
measure: Arterial Pressure Waveforms between groups
timeFrame: Month 1
measure: Arterial Pressure Waveforms between groups
timeFrame: Month 3
measure: Vasomotor endothelial function between groups
timeFrame: Day 0
measure: Vasomotor endothelial function between groups
timeFrame: Month 1
measure: Vasomotor endothelial function between groups
timeFrame: Month 3
measure: Vasomotor endothelial function between groups
timeFrame: Month 6
measure: intima-media thickness of common carotid arteries
timeFrame: Day 0
measure: intima-media thickness of common carotid arteries
timeFrame: Month 6
measure: left ventricular diastolic function
timeFrame: Day 0
measure: left ventricular diastolic function
timeFrame: Month 6
measure: Central venous pressure
timeFrame: Day 0
measure: Central venous pressure
timeFrame: Month 1
measure: Central venous pressure
timeFrame: Month 3
measure: Central venous pressure
timeFrame: Month 6
measure: Arterial Pressure Waveforms of females compared to males
timeFrame: Month 6
measure: Vasomotor endothelial function of females compared to males
timeFrame: Month 6
measure: Bone density
timeFrame: Day 0
measure: Bone density
timeFrame: Month 6
measure: Biological markers of vascular remodeling, oxidative stress and inflammation
timeFrame: Day 0
measure: Biological markers of vascular remodeling, oxidative stress and inflammation
timeFrame: Month 6
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Antonia Perez-Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: