Clinical trial NCT06953518: An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
Official title: An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammation
Keywords: Senolytic
Lead sponsor: Qualia Life Sciences
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA
timeFrame: 1 week
Secondary outcomes:
measure: Remaining biomarkers in the Olink Target 48 Cytokine panel
timeFrame: 1 week
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 1 week
measure: Frailty Index for Elders (FIFE)
timeFrame: 1 week
measure: Depression Anxiety Stress Scale-21 (DASS-21)
timeFrame: 1 week
measure: Aging Male/Female Symptom scale
timeFrame: 1 week
measure: Side effect profile as measured by a custom Safety and Tolerability survey
timeFrame: 1 week
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Qualia Life Sciences
state: California
Study officials:
References: