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

Обзор

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.

Подробное описание

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

Вмешательства

• Пищевая добавка Qualia Senolytic
  Qualia Senolytic manufactured by Qualia Life Science

Первичные конечные точки

• Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA [Срок оценки: 1 week]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Qualia Life Sciences — Carlsbad

Идентификаторы

NCT: NCT06953518 · QLS-010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗