NCT05735886进行中（未招募）不适用
Impact of Urolithin A Supplementation on Mitochondrial Health of Immune Cells (MitoImmune): a Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amazentis SA
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Mitochondrial activity in CD3+ T-cells
研究概览
简要总结
To show that a natural mitophagy activator (Urolithin A) given orally can modulate mitochondrial activity in immune cells in healthy adults and this results in better immune function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adults that do not suffer from an uncontrolled chronic medical condition that carries metabolic consequences (as assessed by the study physician)
- •BMI<35kg/m2
- •Provide informed consent
- •Adults aged 45-70 years, both genders
- •Subjects who have not received any systemic immunosuppression in the past 6 months
- •Subjects with any medical condition that in the opinion of the investigators would compromise the study outcome or the safety of the research participant
排除标准
- •Subject has any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements;
- •Clinically significant abnormal laboratory results at screening
- •Participation in a clinical research trial within 30 days prior to randomization
- •Allergy or sensitivity to study ingredients
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Any condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
- •Current gastrointestinal condition which could interfere with the study (e.g. IBS/IBD, diarrhea, acid reflux disease, dysphagia etc.);
- •Excessive alcohol consumption and/or a smoker
- •Concomitant use of statins
- •Engage in regular moderate or vigorous physically activities (i.e. Category 3 as per the IPAQ activity classification)
- •Concomitant use of corticosteroids, antibiotics, any anabolic steroid, creatine, whey protein supplements, casein or branched-chain amino acids (BCAAs), immune-boosting(Vitamin C, Zinc) or mitochondrial (COQ10, NAD+) supplements within 45 days prior to screening
结局指标
主要结局
Change in Mitochondrial activity in CD3+ T-cells
时间窗: 28 days
Mitochondrial function evaluated as OXPHOS activity via ELISA /Seahorse
Change in percentages of CD3+ T-cell immune cell population
时间窗: 28 days
In particular, number of CD8+ T memory stem cells (identified by expression of CD8+CD45RA+CCR7+CD95+) and naïve-like T cells (CD8+CD45RA+CCR7+CD95-)
次要结局
- Change in pro and anti-inflammatory cytokine levels (IL-6, TNF-a, IL1-B, IL-10) in plasma and/or ex-vivo antigenic stimulation(28 days)
- Change in gene-expression: single cell analysis of CD3+ T-cells(28 days)
- Change in PBMC's immune function assessment (mixed-leukocyte reaction (MLR) via antigenic stimulation(28 days)
- Change in Mitochondrial content on CD3 T-cell populations via Mitotracker staining using flow cytometry(28 days)
- Change in percentages of other immune cell populations (B cells, NK cells, Macrophages, DCs etc.) via flow cytometry(28 days)
- Epigenetic age of PBMCs (DNA Methylation-derived epigenetic age)(28 days)
- Change in Lipid profile(28 days)
- Number of adverse events(28 days)
研究者
研究点 (1)
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