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OpenTrials
Completed

NCT Number: NCT03464760

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

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.

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Key information

Conditions

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3.5g of spirulina per day in 1% silicone

Dietary Supplement

5 tablets of 700mg per day

Placebo

Dietary Supplement

5 tablets per day of potato-based placebo

Primary outcomes

  1. Arterial Pressure Waveforms between groups

    Time frame: Month 6

    Applanation tonometry; m.s-1

Secondary outcomes

  1. Arterial Pressure Waveforms between groups

    Time frame: Day 0

    Applanation tonometry; mm

  2. Arterial Pressure Waveforms between groups

    Time frame: Month 1

    Applanation tonometry; mm

  3. Arterial Pressure Waveforms between groups

    Time frame: Month 3

    Applanation tonometry; mm

  4. Vasomotor endothelial function between groups

    Time frame: Day 0

    % post-ischemic vasorelaxation

  5. Vasomotor endothelial function between groups

    Time frame: Month 1

    % post-ischemic vasorelaxation

  6. Vasomotor endothelial function between groups

    Time frame: Month 3

    % post-ischemic vasorelaxation

  7. Vasomotor endothelial function between groups

    Time frame: Month 6

    % post-ischemic vasorelaxation

  8. intima-media thickness of common carotid arteries

    Time frame: Day 0

    echography; mm

  9. intima-media thickness of common carotid arteries

    Time frame: Month 6

    echography; mm

  10. left ventricular diastolic function

    Time frame: Day 0

    kPa

  11. left ventricular diastolic function

    Time frame: Month 6

    kPa

  12. Central venous pressure

    Time frame: Day 0

    mmHg

  13. Central venous pressure

    Time frame: Month 1

    mmHg

  14. Central venous pressure

    Time frame: Month 3

    mmHg

  15. Central venous pressure

    Time frame: Month 6

    mmHg

  16. Arterial Pressure Waveforms of females compared to males

    Time frame: Month 6

    Applanation tonometry; m.s-1

  17. Vasomotor endothelial function of females compared to males

    Time frame: Month 6

    % post-ischemic vasorelaxation

  18. Bone density

    Time frame: Day 0

    dual-photon absorptiometry

  19. Bone density

    Time frame: Month 6

    dual-photon absorptiometry

  20. Biological markers of vascular remodeling, oxidative stress and inflammation

    Time frame: Day 0

    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

  21. Biological markers of vascular remodeling, oxidative stress and inflammation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Phyco-Biotech

Registry information

Acronym: ANGIO SPIRUL

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2018
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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