NCT03464760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 4, 2025

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

March 8, 2018

Last Update Submit

November 27, 2025

Conditions

Elderly

Outcome Measures

Primary Outcomes (1)

  • Arterial Pressure Waveforms between groups

    Applanation tonometry; m.s-1

    Month 6

Secondary Outcomes (21)

  • Arterial Pressure Waveforms between groups

    Day 0

  • Arterial Pressure Waveforms between groups

    Month 1

  • Arterial Pressure Waveforms between groups

    Month 3

  • Vasomotor endothelial function between groups

    Day 0

  • Vasomotor endothelial function between groups

    Month 1

  • +16 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Spirulina-Silicon supplementation

EXPERIMENTAL
Dietary Supplement: 3.5g of spirulina per day in 1% silicone

Interventions

3.5g of spirulina per day in 1% siliconeDIETARY_SUPPLEMENT

5 tablets of 700mg per day

Spirulina-Silicon supplementation
placeboDIETARY_SUPPLEMENT

5 tablets per day of potato-based placebo

Placebo

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 40077730RESULT

MeSH Terms

Interventions

Silicones

Intervention Hierarchy (Ancestors)

SiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Antonia Perez-Martin, MD

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 14, 2018

Study Start

January 22, 2020

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

December 4, 2025

Record last verified: 2023-10

Locations

FR(1)