Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT03464760
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2018-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012828', 'term': 'Silicones'}], 'ancestors': [{'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial Pressure Waveforms between groups', 'timeFrame': 'Month 6', 'description': 'Applanation tonometry; m.s-1'}], 'secondaryOutcomes': [{'measure': 'Arterial Pressure Waveforms between groups', 'timeFrame': 'Day 0', 'description': 'Applanation tonometry; mm'}, {'measure': 'Arterial Pressure Waveforms between groups', 'timeFrame': 'Month 1', 'description': 'Applanation tonometry; mm'}, {'measure': 'Arterial Pressure Waveforms between groups', 'timeFrame': 'Month 3', 'description': 'Applanation tonometry; mm'}, {'measure': 'Vasomotor endothelial function between groups', 'timeFrame': 'Day 0', 'description': '% post-ischemic vasorelaxation'}, {'measure': 'Vasomotor endothelial function between groups', 'timeFrame': 'Month 1', 'description': '% post-ischemic vasorelaxation'}, {'measure': 'Vasomotor endothelial function between groups', 'timeFrame': 'Month 3', 'description': '% post-ischemic vasorelaxation'}, {'measure': 'Vasomotor endothelial function between groups', 'timeFrame': 'Month 6', 'description': '% post-ischemic vasorelaxation'}, {'measure': 'intima-media thickness of common carotid arteries', 'timeFrame': 'Day 0', 'description': 'echography; mm'}, {'measure': 'intima-media thickness of common carotid arteries', 'timeFrame': 'Month 6', 'description': 'echography; mm'}, {'measure': 'left ventricular diastolic function', 'timeFrame': 'Day 0', 'description': 'kPa'}, {'measure': 'left ventricular diastolic function', 'timeFrame': 'Month 6', 'description': 'kPa'}, {'measure': 'Central venous pressure', 'timeFrame': 'Day 0', 'description': 'mmHg'}, {'measure': 'Central venous pressure', 'timeFrame': 'Month 1', 'description': 'mmHg'}, {'measure': 'Central venous pressure', 'timeFrame': 'Month 3', 'description': 'mmHg'}, {'measure': 'Central venous pressure', 'timeFrame': 'Month 6', 'description': 'mmHg'}, {'measure': 'Arterial Pressure Waveforms of females compared to males', 'timeFrame': 'Month 6', 'description': 'Applanation tonometry; m.s-1'}, {'measure': 'Vasomotor endothelial function of females compared to males', 'timeFrame': 'Month 6', 'description': '% post-ischemic vasorelaxation'}, {'measure': 'Bone density', 'timeFrame': 'Day 0', 'description': 'dual-photon absorptiometry'}, {'measure': 'Bone density', 'timeFrame': 'Month 6', 'description': 'dual-photon absorptiometry'}, {'measure': 'Biological markers of vascular remodeling, oxidative stress and inflammation', 'timeFrame': 'Day 0', 'description': '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'}, {'measure': 'Biological markers of vascular remodeling, oxidative stress and inflammation', 'timeFrame': 'Month 6', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elderly']}, 'referencesModule': {'references': [{'pmid': '40077730', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must have given their free and informed consent and signed the consent form\n* The subject must be a member or beneficiary of a health insurance plan\n* The subject is available for 6 months of follow-up\n* 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\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* 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)\n* Any other chronic pathology requiring medical treatment\n* History of uric acid metabolism disorders (hyperuricemia, gout, urolithiasis).\n* Subject presenting a loss of limitation of autonomy\n* Treated with hormone replacement therapy in females\n* Active smoker or drug user\n* Presence of an abnormality revealed by the pre-inclusion biological assessment of dyslipidemia justifying a prescription medication, diabetes or intolerance to glucose (insulin resistance).\n* Presence of a stenosis (greater than 50% in diameter, NASCET method) or carotid occlusion revealed by the echo-Doppler screening test.\n* Presence of an aneurysm (dilation\\> 30 mm) of the abdominal aorta revealed by the echo-Doppler screening test.\n* Arteriopathy of the lower limbs (toe systolic pressure (tsp) \\<0.7) revealed by the screening test (SysToe™ device).\n* Subject already taking a food supplement based on spirulina or silicon.\n* History of cardio-vascular disease or heart attack\n* 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'}, 'identificationModule': {'nctId': 'NCT03464760', 'acronym': 'ANGIO SPIRUL', 'briefTitle': 'Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of the Effect of Spirulina-Silicon Supplementation on the Morphological, Biomechanical and Functional Characteristics of the Arterial Wall in the Elderly', 'orgStudyIdInfo': {'id': 'LOCAL/2016/APM-01'}, 'secondaryIdInfos': [{'id': '2017-A00981-52', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Spirulina-Silicon supplementation', 'interventionNames': ['Dietary Supplement: 3.5g of spirulina per day in 1% silicone']}], 'interventions': [{'name': '3.5g of spirulina per day in 1% silicone', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 tablets of 700mg per day', 'armGroupLabels': ['Spirulina-Silicon supplementation']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 tablets per day of potato-based placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Antonia Perez-Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Phyco-Biotech', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}