Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355167
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-26
Brief Title:
Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
Interventional Open-label Study of the Effect of an Aquaporin-1 Inhibitor the Bacopaside II Contained in Bacopa-400 on Oxidative Stress in Healthy Volunteers BacOxy_I Study
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_I
Brief Summary:
Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract Bacopa-400 on vascular oxidative stress
Detailed Description:
The Bacopa-400 is a standardized extract of a plant called Bacopa Monnieri which mainly grows in India and neighboring countries The virtues of this plant also called Brahmi have been used in Ayurvedic medicine for millennia in the treatment of chronic neurological diseases accompanied by cognitive impairment and memory disorders as well as for stress management Several companies have subsequently improved the preparation of standardized extracts of Bacopa Monnieri Bacopa-400 from the Belgian firm Deba Pharma was selected because it adheres to good manufacturing practices GMP Currently there are over 289 studies listed regarding the positive role of Bacopa monnieri in cognitive functions in both young and elderly subjects Furthermore no major side effects have been reported following the use of this plant extract in acute or chronic administration in hundreds of people of all ages
Bacopa monnieri plant contains several bacosides including the Bacopaside II a specific inhibitor of the water channel Aquaporin 1 AQP1 AQP1 is part of the aquaporin family responsible for bidirectional transmembrane water transport It is the most abundant aquaporin in mammalian cardiovascular tissue present in myocardial cells endothelial cells and red blood cells AQP1 more than a water channel is also a peroxiporin able to facilitate the passage of hydrogen peroxide H2O2 involved in oxidative stress
In previous work the Pharmacology and Therapeutics FATH department from UCLouvain Brussels discovered the protective effect of Bacopaside II on cardiovascular oxidative stress Through a series of experiments it was demonstrated that Bacopaside II dose dependently attenuates the passage of H2O2 into cardiac myocytes thus preventing hypertrophy induced by neurohormones Additionally in murine models oral administration of Bacopa monnieri extract attenuated cardiac hypertrophy triggered by hypertrophic stimuli This cardiac protection occurs through inhibition of AQP1
Based on this premises a clinical investigation was undertaken to explore the potential of Bacopa-400 in attenuating vascular oxidative stress among healthy volunteers This interventional open-label and monocentric comprised two groups Group A received a daily dose of 400 mg and Group B a daily dose of 800 mg over a 6-week period followed by a 4-week observation period after the cessation of treatment
The primary objective of this study was to assess the impact of Bacopa-400 on oxidative stress in healthy individuals and determine the optimal dosage for maximal efficacy Furthermore the study analyzed the incidence severity and frequency of adverse events including suspected unexpected serious adverse events SUSAR
Bacopa monnieri plant contains several bacosides including the Bacopaside II a specific inhibitor of the water channel Aquaporin 1 AQP1 AQP1 is part of the aquaporin family responsible for bidirectional transmembrane water transport It is the most abundant aquaporin in mammalian cardiovascular tissue present in myocardial cells endothelial cells and red blood cells AQP1 more than a water channel is also a peroxiporin able to facilitate the passage of hydrogen peroxide H2O2 involved in oxidative stress
In previous work the Pharmacology and Therapeutics FATH department from UCLouvain Brussels discovered the protective effect of Bacopaside II on cardiovascular oxidative stress Through a series of experiments it was demonstrated that Bacopaside II dose dependently attenuates the passage of H2O2 into cardiac myocytes thus preventing hypertrophy induced by neurohormones Additionally in murine models oral administration of Bacopa monnieri extract attenuated cardiac hypertrophy triggered by hypertrophic stimuli This cardiac protection occurs through inhibition of AQP1
Based on this premises a clinical investigation was undertaken to explore the potential of Bacopa-400 in attenuating vascular oxidative stress among healthy volunteers This interventional open-label and monocentric comprised two groups Group A received a daily dose of 400 mg and Group B a daily dose of 800 mg over a 6-week period followed by a 4-week observation period after the cessation of treatment
The primary objective of this study was to assess the impact of Bacopa-400 on oxidative stress in healthy individuals and determine the optimal dosage for maximal efficacy Furthermore the study analyzed the incidence severity and frequency of adverse events including suspected unexpected serious adverse events SUSAR
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