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

NCT ID: NCT03464760

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2022-11-30

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.

Conditions

Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

5 tablets per day of potato-based placebo

Spirulina-Silicon supplementation

Group Type: EXPERIMENTAL

3.5g of spirulina per day in 1% silicone

Intervention Type: DIETARY_SUPPLEMENT

5 tablets of 700mg per day

Interventions

3.5g of spirulina per day in 1% silicone

5 tablets of 700mg per day

Intervention Type: DIETARY_SUPPLEMENT

placebo

5 tablets per day of potato-based placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Phyco-Biotech

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonia Perez-Martin, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

CHU Nimes

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 40077730 (View on PubMed)

Other Identifiers

2017-A00981-52

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2016/APM-01

Identifier Type: -

Identifier Source: org_study_id