Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-12 @ 10:06 PM
Study NCT ID:
NCT06505967
Status:
RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NAD+ Levels in the Blood', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAD+ Levels in the Blood']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine if Qualia NAD+ effectively increases NAD+ levels in the blood and to evaluate its safety.\n\nResearchers will compare Qualia NAD+ to a placebo (a look-alike substance that contains no active drug) to assess its efficacy in increasing NAD+ levels in the blood.\n\nParticipants will:\n\nTake Qualia NAD+ or a placebo every day for 4 weeks. Undergo blood tests before and after the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nProvide voluntary, written, informed consent to participate in the study Agree to provide a valid cell phone number and are willing to receive communications through text.\n\nHealthy male and female participants between the ages of 40-65 years of age. Willingness to complete questionnaires, records, and diaries associated with the study.\n\nWilling to not consume any supplements, energy drinks/shots, or other products containing any form of supplemental vitamin B3 (e.g., niacin, niacinamide, nicotinamide ribosome, NMN) starting about 2 weeks prior to the baseline NAD fingerstick test and continuing through the intervention period.\n\nWilling to not begin taking any new supplements during the study period, and to continue taking any supplements they are currently using regularly (with the exception of vitamin B3 containing supplements).\n\nWillingness to self-administer the intracellular NAD fingerstick test kit at home for both a baseline and post-intervention blood sample, and to complete a release form that gives researchers access to the results of these tests.\n\nExclusion criteria:\n\nWomen who are pregnant, breastfeeding, or planning to become pregnant during the trial Known food intolerances/allergy to any ingredients in the product Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer Having had a significant cardiovascular event in the past 6 months Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent'}, 'identificationModule': {'nctId': 'NCT06505967', 'briefTitle': 'Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qualia Life Sciences'}, 'officialTitle': 'Effectiveness of Qualia NAD+ Supplementation on Intracellular NAD Levels: A Randomized Double-Blind Parallel Trial', 'orgStudyIdInfo': {'id': 'NHC-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qualia NAD+', 'interventionNames': ['Dietary Supplement: Qualia NAD+']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Qualia NAD+', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Qualia NAD+ is a novel dietary supplement, formulated to support the maintenance and enhancement of intracellular NAD levels.', 'armGroupLabels': ['Qualia NAD+']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Rice flour', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abhi Ardagh', 'role': 'CONTACT', 'email': 'support@qualialife.com', 'phone': '855-281-2328'}, {'name': 'William Scuba', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qualia Life Sciences', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}], 'centralContacts': [{'name': 'William Scuba', 'role': 'CONTACT', 'email': 'support@qualialife.com', 'phone': '855-281-2328'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only aggregate data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qualia Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}