Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06059131
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-08-01
Brief Title:
Effect of a Specific Aquaporin-1 Inhibitor on Vascular Oxidative Stress in Healthy Volunteers
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bacoxy_II
Brief Summary:
Bacoxy_II study aims to evaluate the efficacy of a standardized Bacopa monnieri extract KeenMind on vascular oxidative stress
Detailed Description:
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
In order to answer to this question the investigators set up the Bacoxy_II clinical study that is a double-blind prospective interventional and controlled study The study will last 4 months including 3 months of treatment and 1 month of post-treatment follow-up This study will include 2 groups of 20 volunteers one group will receive a dose of 320 mgd of Bacopa monnieri and the other group will receive the placebo treatment
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
In order to answer to this question the investigators set up the Bacoxy_II clinical study that is a double-blind prospective interventional and controlled study The study will last 4 months including 3 months of treatment and 1 month of post-treatment follow-up This study will include 2 groups of 20 volunteers one group will receive a dose of 320 mgd of Bacopa monnieri and the other group will receive the placebo treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None