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

NCT06953518 | Not Yet Recruiting

• 1 other identifier: QLS-010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

Senolytic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Qualia Senolytic

ACTIVE COMPARATOR

Dietary Supplement: Qualia Senolytic

Interventions

Qualia Senolytic DIETARY_SUPPLEMENT

Qualia Senolytic manufactured by Qualia Life Science

Qualia Senolytic

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qualia Life Sciences: lead

Study Sites (1)

Qualia Life Sciences

Carlsbad, California, 92011, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

William Scuba

CONTACT

855-281-2328; support@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: May 12, 2025
• Primary Completion: May 18, 2025
• Study Completion: May 18, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)