Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-28 @ 4:23 PM
Study NCT ID:
NCT06219161
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, placebo controlled, double blind, crossover study with a two-week washout period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-12', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of stem cell numbers in blood circulation.', 'timeFrame': 'Changes at 1 and 2 hours after consumption of study product.', 'description': 'Flow cytometry evaluation of stem cell phenotype.'}], 'secondaryOutcomes': [{'measure': 'Change to numbers of circulating HSC- CD45, CD34, CD133.', 'timeFrame': 'Changes at 1 and 2 hours after consumption of study product.', 'description': 'Flow cytometry evaluation of stem cell phenotype.'}, {'measure': 'Change to numbers of circulating CEC - CD45, CD31, CD309.', 'timeFrame': 'Changes at 1 and 2 hours after consumption of study product.', 'description': 'Flow cytometry evaluation of stem cell phenotype.'}, {'measure': 'Change to numbers of circulating MSC-CD45, CD31, CD90.', 'timeFrame': 'Changes at 1 and 2 hours after consumption of study product.', 'description': 'Flow cytometry evaluation of stem cell phenotype.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stem Cells']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to determine the acute and short-term supplementation effect of a commercially available theacrine-containing supplement (NAD3) on numbers of various circulating stem cell populations in older adults.', 'detailedDescription': 'This is a double-blind, placebo-controlled crossover study with 12 participants randomized to receive either NAD3® or a placebo for seven days. Blood samples are collected after an overnight fast, before and after the seven-day supplementation period, as well as one and two hours after the final supplement/placebo dose. Using flow cytometry, circulating stem cells, including lymphocytoid CD34+ stem cells (CD45dimCD34+), stem cells associated with vascular maintenance and repair (CD45dimCD34+CD309+), CD34+ stem cells linked to a progenitor phenotype (CD45dimCD34+CD309neg), circulating endothelial stem cells (CD45negCD31+CD309+), and mesenchymal stem cells (CD45negCD90+) are quantified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* Age 40-70\n* BMI between 21-34.99 kg/m2\n* Vital signs with in normal range (heart rate 60-100 beats/minute, blood pressure (40-44 years - 125/83, 45-49 years- 127/84, 50-54 years -129/85, 55-59 years - 131/86, \\>60 - 134/87), 36.4-37.4 degrees Celsius\n* Sedentary to lightly active (2 or fewer days per week of exercise)\n\nExclusion Criteria:\n\n* Female participants who are lactating, pregnant or planning to become pregnant during the study\n* History of use of illicit drugs or other substances of abuse within 12 months of the screening visit (to be determined at screening)\n* Tobacco during the 90 days prior to screening\n* Current use of medication/dietary supplements that claim to or have an effect on age-related processes, e.g. "anti-aging" supplements. Participants must undergo a ≥7-day washout period of no supplementation to be eligible.\n* Known allergy, intolerance or hypersensitivity to NAD3\n* Self-reported active infection or illness of any kind\n* Cognitively impaired and/or unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT06219161', 'briefTitle': 'The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.', 'organization': {'class': 'OTHER', 'fullName': 'University of Memphis'}, 'officialTitle': 'The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.', 'orgStudyIdInfo': {'id': 'U0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Test product (NAD3)', 'description': '344 mg microcrystalline cellulose,156 mg of a proprietary blend of Wasabia japonica (freeze-dried rhizome) cultivar, standardized to NLT 12,000 ppm isothiocyanates, 97.0% Theacrine, Copper Nicotinic Acid chelated complex (17-20% Copper by ICP-Mass spectroscopy) per capsule', 'interventionNames': ['Dietary Supplement: NAD3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '500 mg of foodgrade mass, and color-matched microcrystalline cellulose per capsule', 'interventionNames': ['Dietary Supplement: NAD3']}], 'interventions': [{'name': 'NAD3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'NAD3 supplement (per capsule): 344 mg microcrystalline cellulose,156 mg of a proprietary blend of Wasabia japonica (freeze-dried rhizome) cultivar, standardized to NLT 12,000 ppm isothiocyanates, 97.0% Theacrine, Copper Nicotinic Acid chelated complex (17-20% Copper by ICP-Mass spectroscopy)', 'armGroupLabels': ['Placebo', 'Test product (NAD3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38152', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The University of Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Memphis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Compound Solutions Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}