Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06953518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA', 'timeFrame': '1 week', 'description': 'Biomarkers in blood, measured using the Olink Target 48 Cytokine panel:\n\nTumor Necrosis Factor (TNF) Interleukin-1 Beta (IL1B) Interleukin-8 (CXCL8) Vascular Endothelial Growth Factor A (VEGFA)'}], 'secondaryOutcomes': [{'measure': 'Remaining biomarkers in the Olink Target 48 Cytokine panel', 'timeFrame': '1 week'}, {'measure': '36-Item Short Form Health Survey (SF-36)', 'timeFrame': '1 week'}, {'measure': 'Frailty Index for Elders (FIFE)', 'timeFrame': '1 week'}, {'measure': 'Depression Anxiety Stress Scale-21 (DASS-21)', 'timeFrame': '1 week'}, {'measure': 'Aging Male/Female Symptom scale', 'timeFrame': '1 week'}, {'measure': 'Side effect profile as measured by a custom Safety and Tolerability survey', 'timeFrame': '1 week', 'description': 'Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Senolytic'], 'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'This open-label pilot study includes adults aged 45 to 79 residing in the United States. The study will last 7 days. Participants will provide blood samples via an at-home finger-prick kit at baseline and day 7 and complete electronic surveys on health indicators at baseline, and days 3 and 7. All procedures are conducted remotely, with no in-person visits, to collect real-world evidence.', 'detailedDescription': 'Objectives Within-group changes in outcomes will be compared from baseline to the end of the study period.\n\nPrimary Outcome Measures:\n\nBiomarkers in blood, measured using the Olink Target 48 Cytokine panel:\n\nTumor Necrosis Factor (TNF) Interleukin-1 Beta (IL1B) Interleukin-8 (CXCL8) Vascular Endothelial Growth Factor A (VEGFA)\n\nSecondary Outcome Measures:\n\nRemaining biomarkers in the Olink Target 48 Cytokine panel 36-Item Short Form Health Survey (SF-36) Frailty Index for Elders (FIFE) Depression Anxiety Stress Scale-21 (DASS-21)\n\nSide effect profile including:\n\nNumber, type, severity, causality, and outcome of adverse events or unanticipated problems\n\nSymptoms of aging, assessed by:\n\nAging Male Symptom scale Aging Female Symptom scale\n\nParticipant Details:\n\nStudy Duration per Participant: 7 days Total Number of Participants: 40'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide voluntary, written, informed consent to participate in the study\n* Agree to provide a valid cell phone number and are willing to receive communications through text.\n* Healthy adults 45 - 79 years of age Can read and write English\n* Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly.\n* Willing to self-administer the fingerstick test kit at home for both a baseline and post-intervention blood sample, and to complete a release form that gives NHC access to the results of these tests.\n* Willing to complete questionnaires, records, and diaries associated with the study.\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial\n* Known food intolerances/allergy to any ingredients in the product\n* Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer\n* Having had a significant cardiovascular event in the past 6 months\n* Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines\n* On immunosuppressive therapy\n* Individuals who were deemed incompatible with the test protocol\n* Adults lacking capacity to consent'}, 'identificationModule': {'nctId': 'NCT06953518', 'briefTitle': 'An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qualia Life Sciences'}, 'officialTitle': 'An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines', 'orgStudyIdInfo': {'id': 'QLS-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Qualia Senolytic', 'interventionNames': ['Dietary Supplement: Qualia Senolytic']}], 'interventions': [{'name': 'Qualia Senolytic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Qualia Senolytic manufactured by Qualia Life Science', 'armGroupLabels': ['Qualia Senolytic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Abhi Argagh', 'role': 'CONTACT', 'email': 'support@qualialife.com', 'phone': '855-281-2328'}], '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qualia Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}