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

NCT06059131 | Completed

• 1 other identifier: 2023/11JAN/014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Bacoxy\_II study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, KeenMind®, on vascular oxidative stress.

Conditions

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

Keywords

vascular oxidative stress; aquaporin 1; AQP1; peroxiporin; H2O2; hydrogen peroxide; cardiovascular diseases; Bacopa monnieri; Bacopaside II; endothelial dysfunction

Outcome Measures

Primary Outcomes (4)

• Ex vivo DCFDA test on red blood cells (RBCs)

  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

  Baseline (V0), 3 months (V1), 4 months (V2)

• Nitrosylated hemoglobin (HbNO)

  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.

  Baseline (V0), 3 months (V1), 4 months (V2)

• Lipid peroxydes

  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.

  Baseline (V0), 3 months (V1), 4 months (V2)

• EndoPAT

  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.

  Baseline (V0), 3 months (V1), 4 months (V2)

Secondary Outcomes (9)

• C-reactive protein (CRP)

  Baseline (V0), 3 months (V1), 4 months (V2)

• Blood count

  Baseline (V0), 3 months (V1), 4 months (V2)

• Ion count

  Baseline (V0), 3 months (V1), 4 months (V2)

• Lipid count

  Baseline (V0), 3 months (V1), 4 months (V2)

• Liver function

  Baseline (V0), 3 months (V1), 4 months (V2)

Study Arms (2)

KeenMind

EXPERIMENTAL

Other: KeenMind

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

KeenMind OTHER

320 mg/d (2 capsules/d) during 3 months

Also known as: Bacopa monnieri

KeenMind

Placebo OTHER

320 mg/d (2 capsules/d) during 3 months

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- healthy volunteers

You may not qualify if:

• any chronic disease
• use of chronic drugs or food supplements
• smoking

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Université Catholique de Louvain: collaborator

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, Belgique, 1200, Belgium

Location

Related Publications (5)

• Pravina K, Ravindra KR, Goudar KS, Vinod DR, Joshua AJ, Wasim P, Venkateshwarlu K, Saxena VS, Amit A. Safety evaluation of BacoMind in healthy volunteers: a phase I study. Phytomedicine. 2007 May;14(5):301-8. doi: 10.1016/j.phymed.2007.03.010. Epub 2007 Apr 17.

  PMID: 17442556 BACKGROUND

• Stough C, Downey LA, Lloyd J, Silber B, Redman S, Hutchison C, Wesnes K, Nathan PJ. Examining the nootropic effects of a special extract of Bacopa monniera on human cognitive functioning: 90 day double-blind placebo-controlled randomized trial. Phytother Res. 2008 Dec;22(12):1629-34. doi: 10.1002/ptr.2537.

  PMID: 18683852 BACKGROUND

• Dave UP, Dingankar SR, Saxena VS, Joseph JA, Bethapudi B, Agarwal A, Kudiganti V. An open-label study to elucidate the effects of standardized Bacopa monnieri extract in the management of symptoms of attention-deficit hyperactivity disorder in children. Adv Mind Body Med. 2014 Spring;28(2):10-5.

  PMID: 24682000 BACKGROUND

• Montiel V, Leon Gomez E, Bouzin C, Esfahani H, Romero Perez M, Lobysheva I, Devuyst O, Dessy C, Balligand JL. Genetic deletion of aquaporin-1 results in microcardia and low blood pressure in mouse with intact nitric oxide-dependent relaxation, but enhanced prostanoids-dependent relaxation. Pflugers Arch. 2014 Feb;466(2):237-51. doi: 10.1007/s00424-013-1325-x. Epub 2013 Jul 20.

  PMID: 23873354 BACKGROUND

• Montiel V, Bella R, Michel LYM, Esfahani H, De Mulder D, Robinson EL, Deglasse JP, Tiburcy M, Chow PH, Jonas JC, Gilon P, Steinhorn B, Michel T, Beauloye C, Bertrand L, Farah C, Dei Zotti F, Debaix H, Bouzin C, Brusa D, Horman S, Vanoverschelde JL, Bergmann O, Gilis D, Rooman M, Ghigo A, Geninatti-Crich S, Yool A, Zimmermann WH, Roderick HL, Devuyst O, Balligand JL. Inhibition of aquaporin-1 prevents myocardial remodeling by blocking the transmembrane transport of hydrogen peroxide. Sci Transl Med. 2020 Oct 7;12(564):eaay2176. doi: 10.1126/scitranslmed.aay2176.

  PMID: 33028705 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Virginie Montiel, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms : placebo vs verum

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: September 28, 2023
• Study Start: January 3, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)