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

Qualia Life Sciences

Status

Not yet enrolling

Conditions

Inflammation

Treatments

Dietary Supplement: Qualia Senolytic

Study type

Interventional

Funder types

Industry

Identifiers

NCT06953518

QLS-010

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

45 to 79 years old

Volunteers

Accepts Healthy Volunteers

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