NCT06059131

Effect of a Specific Aquaporin-1 Inhibitor on Vascular Oxidative Stress in Healthy Volunteers

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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 mg/d of Bacopa monnieri and the other group will receive the placebo treatment.

Conditions

• Oxidative Stress
• Cardiovascular Diseases
• Bacopaside II
• Bacopa Monnieri
• Endothelial Dysfunction
• Aquaporin 1
• AQP1

Interventions

Type	Name	Description
OTHER	KeenMind	320 mg/d (2 capsules/d) during 3 months
OTHER	Placebo	320 mg/d (2 capsules/d) during 3 months

Timeline

• Start date: 2023-01-03
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2023-09-28
• Last updated: 2024-04-30

Locations

1 site across 1 country: Belgium