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

Elderly Clinical Trial

— ANGIO SPIRUL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464760
• Other study ID #: LOCAL/2016/APM-01
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly

Intervention

Dietary Supplement:
• 3.5g of spirulina per day in 1% silicone
5 tablets of 700mg per day
• placebo
5 tablets per day of potato-based placebo

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Phyco-Biotech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Pressure Waveforms between groups	Applanation tonometry; m.s-1	Month 6
Secondary	Arterial Pressure Waveforms between groups	Applanation tonometry; mm	Day 0
Secondary	Arterial Pressure Waveforms between groups	Applanation tonometry; mm	Month 1
Secondary	Arterial Pressure Waveforms between groups	Applanation tonometry; mm	Month 3
Secondary	Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Day 0
Secondary	Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Month 1
Secondary	Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Month 3
Secondary	Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Month 6
Secondary	intima-media thickness of common carotid arteries	echography; mm	Day 0
Secondary	intima-media thickness of common carotid arteries	echography; mm	Month 6
Secondary	left ventricular diastolic function	kPa	Day 0
Secondary	left ventricular diastolic function	kPa	Month 6
Secondary	Central venous pressure	mmHg	Day 0
Secondary	Central venous pressure	mmHg	Month 1
Secondary	Central venous pressure	mmHg	Month 3
Secondary	Central venous pressure	mmHg	Month 6
Secondary	Arterial Pressure Waveforms of females compared to males	Applanation tonometry; m.s-1	Month 6
Secondary	Vasomotor endothelial function of females compared to males	% post-ischemic vasorelaxation	Month 6
Secondary	Bone density	dual-photon absorptiometry	Day 0
Secondary	Bone density	dual-photon absorptiometry	Month 6
Secondary	Biological markers of vascular remodeling, oxidative stress and inflammation	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	Day 0
Secondary	Biological markers of vascular remodeling, oxidative stress and inflammation	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	Month 6