Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-04 @ 12:07 AM
Study NCT ID:
NCT05313867
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-19', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'F0 voice frequency', 'timeFrame': 'Change from baseline at 5 minutes after the intake', 'description': 'The vocal parameters will be evaluated using the Praat software (duration of sound in sec, average duration of pauses in sec, average vocal frequency expressed in Hz (F0), standard deviation of F0 expressed in Hz, minimum and maximum of F0, "jitter " and "shimmer"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress', 'trace elements', 'voice parameters'], 'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'Preliminary data obtained by the company Pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters.\n\nTrace elements are pure minerals essential to the functioning of our body, present in very small quantities. They have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments.\n\nNo scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. The present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female over 18 years of age\n* Healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months)\n* Affiliated to the social security system\n* Signed consent\n\nExclusion Criteria:\n\n* Voice disorders: aphasia, dysphonia, aphonia...\n* Presence of a cardiac pacemaker\n* Person intolerant to lactose, or to any excipient present in the VX 1 product\n* Person under legal protection or unable to give consent\n* Minor\n* Pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception\n* Person deprived of liberty by a judicial or administrative decision or under psychiatric care'}, 'identificationModule': {'nctId': 'NCT05313867', 'briefTitle': 'Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Pronutri'}, 'officialTitle': 'Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects', 'orgStudyIdInfo': {'id': '2021-A02571-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 sequence of 10 tablets containing only excipients', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Trace elements', 'description': 'Nutri VX1 in a single dose (1 sequence of 10 tablets). Nutri VX1 is a complex of trace elements with the status of a food supplement.', 'interventionNames': ['Dietary Supplement: Nutri VX 1']}], 'interventions': [{'name': 'Nutri VX 1', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 sequence of 10 tablets (one intake)', 'armGroupLabels': ['Trace elements']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 sequence of 10 tablets (one intake)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Nice', 'country': 'France', 'facility': "Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est, 24, avenue des Diables Bleus, Campus Saint Jean d'Angély", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Alice GUYON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Pronutri', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clin-Experts', 'class': 'INDUSTRY'}, {'name': 'Plateforme Cocolab', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}