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

Not Applicable

Completed

• Conditions: Elderly
• Interventions: Dietary Supplement: 3.5g of spirulina per day in 1% silicone; Dietary Supplement: placebo

• Registration Number: NCT03464760
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-14
• Study Start: 2020-01-22
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spirulina-Silicon supplementation	3.5g of spirulina per day in 1% silicone	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Arterial Pressure Waveforms between groups	Month 6	Applanation tonometry; m.s-1

Secondary Outcome Measures

Name	Time	Method
Vasomotor endothelial function of females compared to males	Month 6	% post-ischemic vasorelaxation
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
intima-media thickness of common carotid arteries	Month 6	echography; mm
Central venous pressure	Month 6	mmHg
Arterial Pressure Waveforms of females compared to males	Month 6	Applanation tonometry; m.s-1
Vasomotor endothelial function between groups	Month 6	% post-ischemic vasorelaxation
left ventricular diastolic function	Month 6	kPa
Bone density	Month 6	dual-photon absorptiometry
Arterial Pressure Waveforms between groups	Month 3	Applanation tonometry; mm

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France