An Open-Label Pilot Study of Qualia Senolytic Supplementation for the Attenuation of Systemic Inflammatory Cytokines
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Olink Target 48 Cytokine panel - TNF, IL1B, CXCL8, VEGFA
时间窗: 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)
次要结局
- Frailty Index for Elders (FIFE)(1 week)
- 36-Item Short Form Health Survey (SF-36)(1 week)
- Depression Anxiety Stress Scale-21 (DASS-21)(1 week)
- Aging Male/Female Symptom scale(1 week)
- Side effect profile as measured by a custom Safety and Tolerability survey(1 week)
- Remaining biomarkers in the Olink Target 48 Cytokine panel(1 week)