Randomized Controlled and Double-blinded Study of the Effect of a Specific Aquaporin-1 Inhibitor, Bacopaside II (KeenMind®), on Vascular Oxidative Stress in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Lipid peroxydes
研究概览
简要总结
Bacoxy_II study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, KeenMind®, on vascular oxidative stress.
详细描述
The food supplement Bacopa monnieri is a plant used in Ayuverda medicine, especially in the treatment of chronic neurological disease with cognitive impairment and memory disorders and for stress management.
Bacopa monnieri contains several Bacosides including Bacopaside II, a specific inhibitor of aquaporin 1 (AQP1), the main water chanel found in mammalian cardiovacular tissues.
AQP1, more than a water chanel, is a peroxiporin able to facilitate the passage of H2O2.
AQP1 is present in myocyte, endothelial and red blood cells. Concerning the endothelial function, analyses in the FATH laboratory (IREC - UCLouvain), confirm the attenuation of H2O2 transport by AQP1 through Bacopaside II in red blood cells but also in endothelial cells.
As H2O2 is involved in oxidative stress mechanisms and endothelial dysfunction, the investigators hypothezised that the oral intake of Bacopa monnieri containing the Bacopaside II could induce an inhibition of AQP1 and attenuate the passage of H2O2 leading to an attenuation of vascular oxidative stress and endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization is performed by an independent statistical service. The randomization list will be transferred to the hospital pharmacy. The pharmacists will be responsible for the delivery of the capsules (placebo vs. verum). Neither the investigator nor the participant will be aware of the treatment. The code will be unmasked at the end of the study.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- healthy volunteers
排除标准
- •any chronic disease
- •use of chronic drugs or food supplements
结局指标
主要结局
Lipid peroxydes
时间窗: Baseline (V0), 3 months (V1), 4 months (V2)
Lipid peroxidation is oxidative damage that affects cellular membranes, lipoproteins, and other molecules that contain lipids in conditions with oxidative stress. Assessement of changes in lipid peroxides level during the study is a reflect of oxidative status. Lipid peroxydes are measured by an ELISA test.
Nitrosylated hemoglobin (HbNO)
时间窗: Baseline (V0), 3 months (V1), 4 months (V2)
Oxidative stress is involved in the decreased bioavailability of nitric oxide (NO). HbNO a complexe used to assess NO bioavailability. HbNO can be quantify by electron paramagnetic resonance spectroscopy.
EndoPAT
时间窗: Baseline (V0), 3 months (V1), 4 months (V2)
Endo-PAT is a non-invasive technique to assess peripheral arterial tone following a reactive hyperemia phenomenon. Using probes placed on the fingertips, EndoPAT measures changes in vascular tone mediated by the endothelium following reactive hyperemia induced by forearm occlusion using a cuff.
Ex vivo DCFDA test on red blood cells (RBCs)
时间窗: Baseline (V0), 3 months (V1), 4 months (V2)
DCFA is a probe used to assess the presence of intracellular ROS. Red blood cells are incubated with DCFA and H2O2. In cells, DCFA is transformed into DCF in the presence of ROS such as H2O2 and the intensity of the emitted signal can be measured by FACS. This technique allows us to measure kinetically the entry of H2O2 by AQP1 in RBCs
次要结局
- Blood count(Baseline (V0), 3 months (V1), 4 months (V2))
- Lipid count(Baseline (V0), 3 months (V1), 4 months (V2))
- HOMA index(Baseline (V0), 3 months (V1), 4 months (V2))
- C-reactive protein (CRP)(Baseline (V0), 3 months (V1), 4 months (V2))
- Kidney function(Baseline (V0), 3 months (V1), 4 months (V2))
- Ion count(Baseline (V0), 3 months (V1), 4 months (V2))
- Liver function(Baseline (V0), 3 months (V1), 4 months (V2))
- Waist and hip circumference ratio(Baseline (V0), 3 months (V1), 4 months (V2))
- Body mass index, fat mass, lean mass,(Baseline (V0), 3 months (V1), 4 months (V2))