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

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.

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: 3.5g of spirulina per day in 1% silicone

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Pressure Waveforms between groups	Applanation tonometry; m.s-1	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Pressure Waveforms between groups	Applanation tonometry; mm	Day 0
Arterial Pressure Waveforms between groups	Applanation tonometry; mm	Month 1
Arterial Pressure Waveforms between groups	Applanation tonometry; mm	Month 3
Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Day 0
Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Month 1
Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Month 3
Vasomotor endothelial function between groups	% post-ischemic vasorelaxation	Month 6
intima-media thickness of common carotid arteries	echography; mm	Day 0
intima-media thickness of common carotid arteries	echography; mm	Month 6
left ventricular diastolic function	kPa	Day 0
left ventricular diastolic function	kPa	Month 6
Central venous pressure	mmHg	Day 0
Central venous pressure	mmHg	Month 1
Central venous pressure	mmHg	Month 3
Central venous pressure	mmHg	Month 6
Arterial Pressure Waveforms of females compared to males	Applanation tonometry; m.s-1	Month 6
Vasomotor endothelial function of females compared to males	% post-ischemic vasorelaxation	Month 6
Bone density	dual-photon absorptiometry	Day 0
Bone density	dual-photon absorptiometry	Month 6
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Phyco-Biotech
• Investigators: Principal Investigator: Antonia Perez-Martin, MD, CHU Nîmes

Publications and helpful links

General Publications

• Virsolvy A, Benmira AM, Allal S, Demattei C, Sutra T, Cristol JP, Jouy N, Richard S, Perez-Martin A. Benefits of Dietary Supplementation with Specific Silicon-Enriched Spirulina on Arterial Function in Healthy Elderly Individuals: A Randomized, Placebo-Controlled Trial. Nutrients. 2025 Feb 28;17(5):864. doi: 10.3390/nu17050864.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Siloxanes; Organosilicon Compounds; Silicones
• Other Study ID Numbers: LOCAL/2016/APM-01; 2017-A00981-52 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No