Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-27 @ 12:50 PM
Study NCT ID:
NCT02762032
Status:
UNKNOWN
Last Update Posted:
2017-07-24
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natreon Healthy Skin Study - PrimaVie Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2016-03-21', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective visual assessment by photographs', 'timeFrame': '14 weeks', 'description': 'Identify subjectively by visual assessment, the effect of the PrimaVie supplement on skin appearance by the investigator/study physician at the end of 14 weeks of treatment from photographs taken at each time point.'}], 'primaryOutcomes': [{'measure': 'Improvement in non-invasive skin assessment of skin microperfusion', 'timeFrame': '14 weeks after oral supplementation', 'description': 'To see the improvement in noninvasive skin assessment of objective measurements such as skin microperfusion (laser speckle contrast imaging) (scale Pu)'}, {'measure': 'Improvement in non-invasive skin assessment of hydration', 'timeFrame': '14 weeks after oral supplementation', 'description': 'To see the improvement in noninvasive skin assessment of objective measurements such as skin hydration using the DermaLab Combo Series (unit of micro-Siemens uS)'}, {'measure': 'Improvement in non-invasive skin assessment of elasticity', 'timeFrame': '14 weeks after oral supplementation', 'description': 'To see the improvement in noninvasive skin assessment of objective measurements such as skin elasticity using the DermaLab Combo Series (mega Pascal mPa and ms units)'}, {'measure': 'Improvement in non-invasive skin assessment of barrier function', 'timeFrame': '14 weeks after oral supplementation', 'description': 'To see the improvement in noninvasive skin assessment of objective measurements such as barrier function using Trans-Epidermal Water Loss using the DermaLab Combo Series (g/m2/h)'}], 'secondaryOutcomes': [{'measure': 'Gene Chip Analysis', 'timeFrame': '14 weeks', 'description': 'identify the up or down regulation of key youthful skin markers (gene expression) produced by the supplement over the placebo as identified by gene chip analysis after 14 weeks of oral supplementation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin Biopsy', 'PrimaVie', 'Herbal Supplement'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31161927', 'type': 'DERIVED', 'citation': 'Das A, S El Masry M, Gnyawali SC, Ghatak S, Singh K, Stewart R, Lewis M, Saha A, Gordillo G, Khanna S. Skin Transcriptome of Middle-Aged Women Supplemented With Natural Herbo-mineral Shilajit Shows Induction of Microvascular and Extracellular Matrix Mechanisms. J Am Coll Nutr. 2019 Aug;38(6):526-536. doi: 10.1080/07315724.2018.1564088. Epub 2019 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1 of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo (control) to take twice daily for 14 weeks.', 'detailedDescription': 'Subjects will be assessed based on they type of Fitzpatrick skin type they have, will be return for a total of 6 study visits over 14 weeks where the following research activities will take place through the course of the study: medical/dietary history, medications will be recorded, supplement randomization based on one of the three arms will occur at study visit 1, and distribution of the study product will occur at all study visits, supplement tolerabiltity assessment, investigator and subject appearance assessment, photography of the face (left, right and front) will be taken, non-invasive assessments including Trans-epidermal Water Loss, hydration, elasticity, laser speckle perfusion, a skin biopsy of left inner upper arm (only at study visits 2 and 6), adverse event review, and supplement count/compliance review.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects willing to discontinue any dietary or nutritional supplements, other than a general multivitamin, starting two weeks before onset of study and also during the study.\n* Subjects must be willing to maintain their present diet with no major changes throughout the study.\n* Subjects must be willing to take the dietary supplements as required by the study protocol twice daily.\n* Female subjects must be between the ages of 30 to 65 years of age\n* Subjects must provide written informed consent and are willing to comply with all study procedures.\n\nExclusion Criteria:\n\n* Any dermatological disorder that may interfere with the accurate evaluation of the subject's skin.\n* Subjects who are pregnant, breast feeding, or planning a pregnancy.\n* Clinically significant unstable medical disorders.\n* History of, diabetes, heart or kidney disease\n* History of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.\n* Any skin disease in the area of the upper inner arm where the biopsies will be obtained.\n* Currently taking the following medications:\n\n * Steroids\n * Beta-blockers\n * Immunosuppressant's\n * Hydochlorothiazide,\n * Statins\n * Aspirin\n * ACE Inhibitors\n * Muscle relaxants\n * Stimulants\n* Prisoners\n* Males"}, 'identificationModule': {'nctId': 'NCT02762032', 'briefTitle': 'Natreon Healthy Skin Study - PrimaVie Supplement', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function', 'orgStudyIdInfo': {'id': 'DCS-71-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': '15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.', 'interventionNames': ['Dietary Supplement: PrimaVie Herbal Supplement 125']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': '15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.', 'interventionNames': ['Dietary Supplement: PrimaVie Herbal Supplement 250']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3', 'description': '15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PrimaVie Herbal Supplement 125', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PrimaVie'], 'description': '125 mg to take BID for 14 weeks in Arm 1', 'armGroupLabels': ['Arm 1']}, {'name': 'PrimaVie Herbal Supplement 250', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PrimaVie'], 'description': '250 mg to take BID for 14 weeks in Arm 2', 'armGroupLabels': ['Arm 2']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['control supplement'], 'description': 'Placebo supplement to take BID for 14 weeks in Arm 3', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Allison, RN', 'role': 'CONTACT', 'email': 'Lauren.Allison@osumc.edu', 'phone': '614-366-2783'}, {'name': 'Elizabeth Murphy, BS', 'role': 'CONTACT', 'email': 'elizabeth.murphy@osumc.edu', 'phone': '614-685-3173'}], 'facility': 'OSU Hospital East', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sashwati Roy, Ph.D', 'role': 'CONTACT', 'email': 'sashwati.roy@osumc.edu', 'phone': '614-247-7657'}], 'facility': 'Davis Heart and Lung Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy H Hoover, LPN', 'role': 'CONTACT', 'email': 'Amy.Hoover@osumc.edu', 'phone': '614-293-0390'}, {'name': 'Gayle M Gordillo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Martha Morehouse Medical Plaza 2050 Kenny Road', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Elizabeth A Murphy, BS', 'role': 'CONTACT', 'email': 'elizabeth.murphy@osumc.edu', 'phone': '9377283980'}, {'name': 'Gayle M Gordillo, M.D.', 'role': 'CONTACT', 'email': 'gayle.gordillo@osumc.edu', 'phone': '614-293-8566'}], 'overallOfficials': [{'name': 'Gayle M Gordillo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Natreon, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gayle Gordillo', 'investigatorAffiliation': 'Ohio State University'}}}}