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Not yet recruiting NCT06953518

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

No phase Interventional Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Qualia Senolytic.
Who it may be relevant to
Registry conditions: Inflammation. Basic parameters: 45 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Dietary supplement Qualia Senolytic
    Qualia Senolytic manufactured by Qualia Life Science

Primary outcome measures

  • Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA [Time frame: 1 week]
Secondary outcome measures (6)
  • Remaining biomarkers in the Olink Target 48 Cytokine panel [Time frame: 1 week]
  • 36-Item Short Form Health Survey (SF-36) [Time frame: 1 week]
  • Frailty Index for Elders (FIFE) [Time frame: 1 week]
  • Depression Anxiety Stress Scale-21 (DASS-21) [Time frame: 1 week]
  • Aging Male/Female Symptom scale [Time frame: 1 week]
  • Side effect profile as measured by a custom Safety and Tolerability survey [Time frame: 1 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Qualia Life Sciences — Carlsbad

Identifiers

NCT: NCT06953518 · QLS-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗