Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 7:09 AM
Study NCT ID:
NCT05033795
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipidomics', 'timeFrame': 'three months', 'description': 'Different concentration in cutaneous lipids'}], 'secondaryOutcomes': [{'measure': 'Urinomics', 'timeFrame': 'three months', 'description': 'quantfication of different urinary metabolites'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin']}, 'descriptionModule': {'briefSummary': 'Evaluation of changes in skin metabolism after one month of intake of Acqua Rocchetta (water A) vs bicarbonate-calcic mediomineral water (water B) (reprogramming effect on skin metabolism); Evaluation of urinary profiles after intake of Acqua Rocchetta (water A) vs bicarbonate-calcic mediomineral water (water B) and possible relation with skin metabolites.', 'detailedDescription': 'This is a single-center, interventional, randomized controlled clinical trial conducted in healthy volunteers, in a double blind (subject and investigator).\n\nThe study will include age-matched female subjects who blindly take water A or water B, both marketed as food and not supplements, therefore evaluated annually by the relevant bodies (ASL, NAS and the Central Inspectorate for quality protection. and the repression of fraud on agri-food products (Icqrf)).\n\nWomen between 30 and 50 years old will be chosen who have a skin aging pattern very different from the male sex and governed by the oscillations of the menstrual cycle. A positive result on this population would be of crucial importance in terms of nutriceuticals and generalizability.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy female subjects\n* in good health without disease with an ICD code in compliance with the World Health Organisation definition (a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." )\n* abstemious\n* individuals who agree to sign an informed consent form\n* individuals who follow an omnivorous diet\n\nExclusion Criteria:\n\n* subjects outside the age range considered\n* smokers and/or those with chronic or acute diseases coded by the ICD-10 system\n* persons who do not consent to sign the informed consent form\n* subjects who follow diets that are not omnivorous or with fattening / slimming purposes\n* subjects undergoing hormonal or contraceptive hormonal therapies or in general drugs that may alter the hydroelectric balance\n* persons with significant alterations in the menstrual cycle (amenorrhoea or dysmenorrhoea).\n* use of alcohol.\n* pregnancy (verified by self-declaration) and/or breastfeeding\n* allergy to the components of Leukopor'}, 'identificationModule': {'nctId': 'NCT05033795', 'briefTitle': 'Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Metabolomic Evaluation of the Impact of Rocchetta Water on the Skin of Healthy Patients Through the Innovative Method of Artificial Intelligence.', 'orgStudyIdInfo': {'id': 'VALORE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Water A', 'description': '2 L of water A per day', 'interventionNames': ['Dietary Supplement: Water A']}, {'type': 'OTHER', 'label': 'Water B', 'description': '2 L of water B per day', 'interventionNames': ['Dietary Supplement: Water B']}], 'interventions': [{'name': 'Water A', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 L of water A per day', 'armGroupLabels': ['Water A']}, {'name': 'Water B', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 L of water B per day', 'armGroupLabels': ['Water B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Pigatto, Prof', 'role': 'CONTACT'}], 'facility': 'IRCSS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Paolo Pigatto, Prof', 'role': 'CONTACT', 'email': 'paolo.pigatto@unimi.it', 'phone': '0266214761'}], 'overallOfficials': [{'name': 'Paolo Pigatto, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCSS Istituto Ortopedico Galeazzi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}