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

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ClinicalTrials.gov Identifier: NCT03464760
Recruitment Status : Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Phyco-Biotech
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Elderly Dietary Supplement: 3.5g of spirulina per day in 1% silicone Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

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




Primary Outcome Measures :
  1. Arterial Pressure Waveforms between groups [ Time Frame: Month 6 ]
    Applanation tonometry; m.s-1


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464760


Contacts
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Contact: Antonia Perez-Martin, MD +33 (0)4 66 68 33 13 antonia.perez.martin@chu-nimes.fr

Locations
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France
CHU Nimes Not yet recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Sub-Investigator: Sarah Coudray, MD         
Sub-Investigator: Jeremy Laurent, MD         
Sub-Investigator: Jean-Eudes Trihan, MD         
Sub-Investigator: Isabelle Aichoun, MD         
Sub-Investigator: Jennifer Hampton, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Phyco-Biotech
Investigators
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Principal Investigator: Antonia Perez-Martin, MD CHU Nimes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03464760     History of Changes
Other Study ID Numbers: LOCAL/2016/APM-01
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Silicon
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs