ANGIO SPIRUL: Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Dietary Supplement: placebo
5 tablets per day of potato-based placebo
|
| Experimental: Spirulina-Silicon supplementation
|
Dietary Supplement: 3.5g of spirulina per day in 1% silicone
5 tablets of 700mg per day
|
Outcome Measures
Primary Outcome Measures
- Arterial Pressure Waveforms between groups [Month 6]
Applanation tonometry; m.s-1
Secondary Outcome Measures
- Arterial Pressure Waveforms between groups [Day 0]
Applanation tonometry; mm
- Arterial Pressure Waveforms between groups [Month 1]
Applanation tonometry; mm
- Arterial Pressure Waveforms between groups [Month 3]
Applanation tonometry; mm
- Vasomotor endothelial function between groups [Day 0]
% post-ischemic vasorelaxation
- Vasomotor endothelial function between groups [Month 1]
% post-ischemic vasorelaxation
- Vasomotor endothelial function between groups [Month 3]
% post-ischemic vasorelaxation
- Vasomotor endothelial function between groups [Month 6]
% post-ischemic vasorelaxation
- intima-media thickness of common carotid arteries [Day 0]
echography; mm
- intima-media thickness of common carotid arteries [Month 6]
echography; mm
- left ventricular diastolic function [Day 0]
kPa
- left ventricular diastolic function [Month 6]
kPa
- Central venous pressure [Day 0]
mmHg
- Central venous pressure [Month 1]
mmHg
- Central venous pressure [Month 3]
mmHg
- Central venous pressure [Month 6]
mmHg
- Arterial Pressure Waveforms of females compared to males [Month 6]
Applanation tonometry; m.s-1
- Vasomotor endothelial function of females compared to males [Month 6]
% post-ischemic vasorelaxation
- Bone density [Day 0]
dual-photon absorptiometry
- Bone density [Month 6]
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
- Biological markers of vascular remodeling, oxidative stress and inflammation [Month 6]
Total cholesterol, High density lipoproteins, Triglycerides, Complete Blood Count, high-sensitivity C-reactive protein, IsoP, 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
Eligibility Criteria
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
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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)
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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
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Presence of an abnormality revealed by the pre-inclusion biological assessment of dyslipidemia justifying a prescription medication, diabetes or intolerance to glucose (insulin resistance).
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Nimes | Nîmes | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
- Phyco-Biotech
Investigators
- Principal Investigator: Antonia Perez-Martin, MD, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LOCAL/2016/APM-01