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NCT Number: NCT06953518

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.

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Key information

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualia Senolytic

Dietary Supplement

Qualia Senolytic manufactured by Qualia Life Science

Primary outcomes

  1. Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA

    Time frame: 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 outcomes

  1. Remaining biomarkers in the Olink Target 48 Cytokine panel

    Time frame: 1 week

  2. 36-Item Short Form Health Survey (SF-36)

    Time frame: 1 week

  3. Frailty Index for Elders (FIFE)

    Time frame: 1 week

  4. Depression Anxiety Stress Scale-21 (DASS-21)

    Time frame: 1 week

  5. Aging Male/Female Symptom scale

    Time frame: 1 week

  6. Side effect profile as measured by a custom Safety and Tolerability survey

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

William Scuba

CONTACT

[email protected]

855-281-2328

Sponsors and collaborators

Lead sponsor

Qualia Life Sciences

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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