Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT07202403
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-01
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013095', 'term': 'Spermidine'}], 'ancestors': [{'id': 'D011700', 'term': 'Putrescine'}, {'id': 'D015317', 'term': 'Biogenic Polyamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011073', 'term': 'Polyamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2031-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'Baseline to Day 112', 'description': 'Assessment of toxicity of therapeutic intervention. Toxicity will be assessed through adverse event monitoring conducted at clinic visits or by phone, with adverse events evaluated and graded using CTCAE v5.0.'}], 'secondaryOutcomes': [{'measure': 'Change in systemic immune milieu', 'timeFrame': 'Baseline and approximately every 28 days through Day 112 (final study visit).', 'description': 'Change in circulating immune biomarkers from baseline and across dose levels, including cytokines and chemokines and immune cell subsets.'}, {'measure': 'Change in systemic metabolic milieu', 'timeFrame': 'Baseline and approximately every 28 days through Day 112 (final study visit).', 'description': 'Metabolomics profiling to quantify circulating plasma metabolites and assess dynamic changes at each dose level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spermidine', 'aging', 'longevity', 'healthspan'], 'conditions': ['Aging', 'Longevity']}, 'descriptionModule': {'briefSummary': 'This is a multi-cohort, open-label, adaptive trial designed to evaluate the safety, tolerability, and biological effects of dietary supplements and other aging-targeted therapies.\n\nCohort 1 is a single-arm, open-label, intrapatient dose-escalation study evaluating the effects of escalating doses of spermidine in 10 participants. Patients will have baseline blood drawn and subsequently start daily administration of spermidine. They will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg.\n\nSubsequent cohorts will evaluate additional agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 75\n* Patients without known significant organ dysfunction, based on standard blood tests within the last year\n\nExclusion Criteria:\n\n* Patients taking any immunomodulatory medications that the investigator or treating physician believe may alter the immune response to the study agent (e.g. biologic antibodies, immunosuppressants)\n* Patients actively receiving any therapy that, in the determination of the investigator, may impact the effect of the study agent.\n* Patients who, in the opinion of the treating investigator, will not be able to follow treatment and defined follow-up\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07202403', 'briefTitle': 'Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Atria Research and Global Health Institute (ARGHI)'}, 'officialTitle': 'Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies', 'orgStudyIdInfo': {'id': '#25-02-400-2231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spermidine', 'description': 'Participants will receive capsules for three consecutive 28-day courses with escalating doses of 40mg, 120mg, and 400mg.', 'interventionNames': ['Dietary Supplement: Spermidine']}], 'interventions': [{'name': 'Spermidine', 'type': 'DIETARY_SUPPLEMENT', 'description': "Spermidine is a polyamine that forms naturally in plants, animals, and microorganisms as a byproduct of protein breakdown. While it's found in various foods, the highest concentrations are in wheat germ, soy, and fermented foods like cheese and miso (Madeo et al. 2018). Spermidine is known for its role in promoting autophagy, a cellular process that helps to clear damaged cells and improve overall cellular function (Eisenberg et al. 2009; Gabandé-Rodríguez, Gómez de Las Heras, and Mittelbrunn 2019). As a result, spermidine has recently attracted significant scientific interest for its potential to enhance lifespan and overall health in laboratory studies.", 'armGroupLabels': ['Spermidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Atria Research and Global Health Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'To safeguard participant privacy, only fully de-identified data may be shared with qualified researchers under appropriate data use agreements and in compliance with all applicable privacy regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atria Research and Global Health Institute (ARGHI)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}