Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-03-05 @ 4:33 AM
Study NCT ID:
NCT05296993
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Efficacy of Extended Longevity Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epigenetic Age', 'timeFrame': 'Testing will compare the change in results from baseline to 3 months', 'description': 'Serum epigenetic aging test'}, {'measure': 'Epigenetic Age', 'timeFrame': 'Testing will compare the change in results after completion of intervention with baseline', 'description': 'serum epigenetic aging test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to quantifiably determine if the Extended Longevity Protocol has a significant clinical effect on epigenetic age.', 'detailedDescription': "This is a prospective non-randomized clinical study of 15 patients to determine if the safety and effectiveness of the Extended Longevity Protocol's impact on the nine determinant factors of aging can decelerate aging.\n\nThere is evidence that the Extended Longevity Protocol decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of the Extended Longevity Protocol as an effective treatment option to improve clinical care of healthy individual's biological age thus prolonging longevity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8 Men and 7 Women\n* Must between 55-75 years old\n* Patient must be able to comply with treatment plan and laboratory tests\n* Patients must have adequate immune system function, with no known immunodeficiency disease\n\nExclusion Criteria:\n\n* Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision\n* No immune system issues or immunodeficiency disease\n* No history of viral illness which could be reactivated by immune downregulation\n* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease\n* Diagnosis of a transient ischemic attack in the 6 months prior to screening\n* Patients infected with hepatitis, C or HIV\n* Patients with Body Mass Index (BMI) \\> 40 kg/m2\n* Presence of active infection\n* Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study\n* Unable or unwilling to provide required blood sample for testing'}, 'identificationModule': {'nctId': 'NCT05296993', 'briefTitle': 'Safety & Efficacy of Extended Longevity Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'TruDiagnostic'}, 'officialTitle': 'The Safety and Effectiveness of the Extended Longevity Protocol on the Epigenetic Aging Rate in Healthy Individuals', 'orgStudyIdInfo': {'id': 'TD-EL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extracts', 'description': 'The ingredients found in these serums are all naturally occurring ingredients extracted from a variety of plant species: Pinetonal, Thyvolve, Telogenic, Sentophagy, Inflasolve, Stemegenis, and CMEnhance', 'interventionNames': ['Dietary Supplement: Extracts found in the Extended Longevity supplements']}], 'interventions': [{'name': 'Extracts found in the Extended Longevity supplements', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingredients found in these serums are all naturally occurring, and extracted from a variety of plant species.', 'armGroupLabels': ['Extracts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92008', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Quantum Functional Medicine', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TruDiagnostic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}