InflammationNCT06953518
An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
A study testing Qualia Senolytic in people with Inflammation, run by Qualia Life Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Qualia Senolytic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 18 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Qualia Life Sciences
Carlsbad, California, 92011
Abhi Argagh, 855-281-2328, support@qualialife.com
About this study
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.
Read the 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
- Conditions
- Inflammation
- Being tested
- Qualia Senolytic
- Keywords
- Senolytic
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualia SenolyticDietary supplement
Qualia Senolytic manufactured by Qualia Life Science
| Study group | Role | What they receive |
|---|---|---|
| Qualia Senolytic | Active comparator | Not described Receives: Dietary Supplement: Qualia Senolytic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 week
Secondary outcomes (6)
Remaining biomarkers in the Olink Target 48 Cytokine panel
Measured: 1 week
36-Item Short Form Health Survey (SF-36)
Measured: 1 week
Frailty Index for Elders (FIFE)
Measured: 1 week
Depression Anxiety Stress Scale-21 (DASS-21)
Measured: 1 week
Aging Male/Female Symptom scale
Measured: 1 week
Side effect profile as measured by a custom Safety and Tolerability survey
Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start12 May 2025 (estimated)
- Primary completion18 May 2025 (estimated)
- Study completion18 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953518
- Sponsor's protocol ID
- QLS-010
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
- ClinicalTrials.gov ID
- NCT06953518
- Acronym / sponsor ID
- QLS-010
- Conditions
- Inflammation
- Keywords
- Senolytic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 18 May 2025 (estimated)
- Study completion
- 18 May 2025 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualia Senolytic | Active comparator | Dietary Supplement: Qualia Senolytic |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualia SenolyticQualia Senolytic manufactured by Qualia Life Science | Dietary supplement | Qualia Senolytic |
Primary outcome
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)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Senolytic in people with Inflammation, run by Qualia Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Scuba (855-281-2328, support@qualialife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.