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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation
• Intervention / Treatment: Dietary supplement: Qualia Senolytic

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Scuba; Phone Number: 855-281-2328; Email: support@qualialife.com

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92011
      • Qualia Life Sciences
      • Contact: Abhi Argagh; Phone Number: 855-281-2328; Email: support@qualialife.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Qualia Senolytic	Dietary supplement: Qualia Senolytic; Qualia Senolytic manufactured by Qualia Life Science

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA	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)	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remaining biomarkers in the Olink Target 48 Cytokine panel		1 week
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	Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey	1 week

Collaborators and Investigators

• Sponsor: Qualia Life Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 12, 2025
• Primary Completion (Estimated): May 18, 2025
• Study Completion (Estimated): May 18, 2025

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Senolytic
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: QLS-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No