Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-04-21 @ 8:59 AM
Study NCT ID:
NCT05459961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-30
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Responses to Spermidine Supplementation.
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomised double blind placebo controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety and effects of a high purity Spermidine supplement in healthy older men.', 'timeFrame': 'Baseline, and after one, three, four and seven weeks at each study visit. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.', 'description': 'Subjects will be evaluated using clinical and laboratory safety testing at baseline and each subsequent study visit.\n\nEach participant will be tracked longitudinally during the study using clinical and laboratory safety parameters'}], 'secondaryOutcomes': [{'measure': 'Polyamine levels in urine and blood', 'timeFrame': 'Baseline, one week, and one month', 'description': 'Polyamine levels at each study visit'}, {'measure': 'Serum lipidomics', 'timeFrame': 'baseline, one week, and one month', 'description': 'targeted'}, {'measure': 'CRP marker of inflammatory activity', 'timeFrame': 'Baseline, and one month', 'description': 'C reactive protein'}, {'measure': 'Evaluation of molecular biology and bioeffect signalling using untargeted and targeted Metabolomics', 'timeFrame': 'Baseline, one week, and one month. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.', 'description': 'Targeted analysis of spermidine, other polyamines, and approximately 250 other biomarkers using both mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy detection technology.\n\nUntargeted analysis of small molecule biomarkers using MS detection.\n\nThe metabolite profiles of each participant will be tracked longitudinally during the study and changes to targeted or untargeted metabolite profiles occurring between visits due to supplementation or washout from treatment will be evaluated.'}, {'measure': 'Urinary untargeted and targeted metabolomics. Evaluation of molecular biology and bioeffect signalling and biomarker assessment', 'timeFrame': 'Baseline, one week, and one month. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.', 'description': 'Targeted analysis for small molecule biomarkers of human genomic, dietary and microbiome origin including amino acids (human), 2-furoylglycine (dietary), 3-hydroxyhippurate (microbial metabolism) and approximately 50 others using nuclear magnetic resonance (NMR) detection technology. Untargeted analysis of small molecule biomarkers of human genomic, dietary and microbiome origin using mass spectrometry (MS) and NMR spectroscopy detection.'}, {'measure': 'Autophagy assay', 'timeFrame': 'Baseline and one week', 'description': 'Western blot or Elisa assay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '39405978', 'type': 'DERIVED', 'citation': 'Keohane P, Everett JR, Pereira R, Cook CM, Blonquist TM, Mah E. Supplementation of spermidine at 40 mg/day has minimal effects on circulating polyamines: An exploratory double-blind randomized controlled trial in older men. Nutr Res. 2024 Dec;132:1-14. doi: 10.1016/j.nutres.2024.09.012. Epub 2024 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'Spermidine is naturally present in cells, organs, circulating cardiovascular system, and as part of our normal dietary intake. Studies suggest Spermidine is involved in antioxidation, autophagy, apoptosis, and immune regulation. Spermidine is typically present in foods of plant origin, such as natto, beans, fruits, vegetables, cheese, potatoes, bread, and cereals. Adequate spermidine dietary intake is important, given evidence of declining spermidine levels with age in humans and other species, and the evidence for positive effects of spermidine supplementation on age related biology.\n\nTo date, human research studies utilised extracts containing low levels of spermidine (\\< 10%) and multiple other constituents, but this study will use pure spermidine to explore relevant mechanisms of action, biological effects, and identify potential biomarkers of positive biological effects.', 'detailedDescription': 'This is a placebo controlled, double blind, randomised, within subject controlled study of supplementation with oral spermidine or placebo each for up to four weeks. The primary objective of this exploratory study is to examine the safety and biological effects of this pure full-dose spermidine supplement on metabolomics, inflammatory and metabolic markers, and transcriptomics.\n\nStudy subjects are generally healthy males aged 50-70 After screening, subjects will enter a two week run-in (stabilisation) phase and then be randomised to blinded active or placebo for the first one week supplementation period. After a washout period, subjects will receive either blinded placebo or active for a second supplementation period of up to four weeks. The full study will require six visits by each study subject to the study site over a period of nine weeks, for blood and urine samples, and dietary intake assessments.\n\nSubjects are required to maintain a normal consistent dietary intake during the study and abstain from alcohol in the 24 hours before study visits.\n\nAssays include routine haematology and chemistry, CRP (C reactive protein), lipid screen, serum and urine metabolomics and polyamines, lipidomics, transcriptomics, and autophagy assays.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCaucasian men, 50-70 years of age\n\nNon-user or former users (cessation ≥6 months) of nicotine products (e.g., cigarettes, chewing tobacco) during the study period.\n\nNon-user or former users (cessation ≥6 months) of any marijuana or hemp products and no plans to use marijuana or hemp products during the study period\n\nWilling to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.\n\nNo health conditions that would prevent the subject from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history, physical examination, and routine laboratory test results.\n\nUnderstands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.\n\nExclusion Criteria:\n\nAbnormal laboratory test results of clinical significance\n\nClinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study product\n\nType I or Type II diabetes mellitus.\n\nUncontrolled pulmonary (including uncontrolled asthma), cardiac, hepatic, renal, endocrine, hematologic, immunologic, or neurologic disease.\n\nHad a positive SARS-CoV2 (COVID) test and experienced symptoms for \\> 2 months (i.e. long COVID)\n\nHas a condition the Clinical Investigator believes would interfere with ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk'}, 'identificationModule': {'nctId': 'NCT05459961', 'briefTitle': 'Metabolic Responses to Spermidine Supplementation.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chrysea Labs Lda'}, 'officialTitle': 'Randomized, Double-Blind, Crossover Study to Assess the Effects of a Spermidine Supplement on Metabolomics in Older Men', 'orgStudyIdInfo': {'id': 'BIO2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active', 'description': 'oral spermidine supplement', 'interventionNames': ['Dietary Supplement: oral spermidine']}, {'type': 'NO_INTERVENTION', 'label': 'placebo', 'description': 'matching placebo'}], 'interventions': [{'name': 'oral spermidine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral supplement', 'armGroupLabels': ['active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Biofortis Innovation Services', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}], 'overallOfficials': [{'name': 'Kathleen Kelley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biofortis Innovation Services Addison, IL, United States, 60101'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chrysea Labs Lda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}