An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines

Not Applicable

Not yet recruiting

• Conditions: Inflammation

• Registration Number: NCT06953518
• Lead Sponsor: Qualia Life Sciences

Brief Summary

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.

Detailed Description

Objectives Within-group changes in outcomes will be compared from baseline to the end of the study period.

Primary Outcome Measures:

Biomarkers in blood, measured using the Olink Target 48 Cytokine panel:

Tumor Necrosis Factor (TNF) Interleukin-1 Beta (IL1B) Interleukin-8 (CXCL8) Vascular Endothelial Growth Factor A (VEGFA)

Secondary Outcome Measures:

Remaining 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)

Side effect profile including:

Number, type, severity, causality, and outcome of adverse events or unanticipated problems

Symptoms of aging, assessed by:

Aging Male Symptom scale Aging Female Symptom scale

Participant Details:

Study Duration per Participant: 7 days Total Number of Participants: 40

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Study Start: 2025-05-12
• Primary Completion: 2025-05-18
• Study Completion: 2025-05-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Provide voluntary, written, informed consent to participate in the study
• Agree to provide a valid cell phone number and are willing to receive communications through text.
• Healthy adults 45 - 79 years of age Can read and write English
• Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly.
• 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.
• Willing to complete questionnaires, records, and diaries associated with the study.

Exclusion Criteria

• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Known food intolerances/allergy to any ingredients in the product
• Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
• Having had a significant cardiovascular event in the past 6 months
• Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
• On immunosuppressive therapy
• Individuals who were deemed incompatible with the test protocol
• Adults lacking capacity to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA	1 week	Biomarkers in blood, measured using the Olink Target 48 Cytokine panel: Tumor Necrosis Factor (TNF) Interleukin-1 Beta (IL1B) Interleukin-8 (CXCL8) Vascular Endothelial Growth Factor A (VEGFA)

Secondary Outcome Measures

Name	Time	Method
36-Item Short Form Health Survey (SF-36)	1 week
Frailty Index for Elders (FIFE)	1 week
Depression Anxiety Stress Scale-21 (DASS-21)	1 week
Aging Male/Female Symptom scale	1 week
Side effect profile as measured by a custom Safety and Tolerability survey	1 week	Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey
Remaining biomarkers in the Olink Target 48 Cytokine panel	1 week

Trial Locations

Locations (1)

Qualia Life Sciences; 🇺🇸 Carlsbad, California, United States