Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress

NCT06355167 | Completed

• 1 other identifier: Bacoxy_I
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Bacoxy\_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, 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; 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 (dichlorofluorescein diacetate) is a probe used to assess the presence of intracellular reactive oxygen species (ROS). Red blood cells are incubated with DCFA and extracellular hydrogen peroxide (H2O2). After passive diffusion into the cells and upon encountering ROS, DCFDA undergoes conversion to produce a highly fluorescent compound, the DCF (2',7'-Dichlorofluorescein). This resulting fluorescence intensity (arbitrary unit) was quantified using FACS. This technique allowed us to measure kinetically the entry of ROS as H2O2 in RBCs.

  Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)

• Plasma lipid peroxydes

  Lipid peroxidation (µM) is a form of oxidative damage that impacts cellular membranes, lipoproteins, and other lipid-containing molecules under conditions of oxidative stress. Assessing changes in lipid peroxide levels during the study served as a reflection of oxidative status. Plasma lipid peroxides were quantified using a colorimetric test using the 3,3',5,5'-tetramethylbenzidine (TMB).

  Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)

• Methemoglobin in red blood cells

  Methemoglobin is the oxidized form of hemoglobin, where the iron atom in the heme group is oxidized from the ferrous to the ferric state. Exposure to oxidative stress can lead to the formation of methemoglobin making the latter a biomarker of vascular oxidative stress. Methemoglobin levels (arbitrary unit) were measured by electron paramagnetic resonance spectroscopy.

  Baseline (V0), 6 weeks (V4), 10 weeks (V6)

• Nitrosylated hemoglobin (HbNO) in red blood cells

  Vascular oxidative stress is involved in the decreased of nitric oxide (NO) bioavailability. Erythrocyte 5-α-coordinate nitrosyl-hemoglobin or nitrosylated hemoglobin (HbNO) is a complexe between NO and deoxyhemoglobin serving as a marker for NO bioavailability. HbNO levels (nM) were quantified using electron paramagnetic resonance spectroscopy

  Baseline (V0), 6 weeks (V4), 10 weeks (V6)

Secondary Outcomes (15)

• haemoglobin

  Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)

• haematocrit

  Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)

• Red blood cells count

  Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)

• Sodium

  Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)

• Potassium

  Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)

Study Arms (2)

1 dose: 1 capsule of Bacopa monnieri (400mg)

OTHER

Group A: 400mg/d of Bacopa monnieri

Dietary Supplement: Bacopa monnieri

2 doses: 2 capsules of Bacopa monnieri (800mg)

OTHER

Group B: 800 mg/d of Bacopa monnieri

Dietary Supplement: Bacopa monnieri

Interventions

Bacopa monnieri DIETARY_SUPPLEMENT

Daily oral intake of Bacopa monnieri during 6 weeks

Also known as: Bacopa-400

1 dose: 1 capsule of Bacopa monnieri (400mg); 2 doses: 2 capsules of Bacopa monnieri (800mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Effective contraception

You may not qualify if:

• Any chronic disease
• Any chronic use of drug
• Pregnancy and breast feeding
• Gastro-intestinal diseases (e.g. ulcer, gastro-oesophageal reflux, lactose intolerance)

Sponsors & Collaborators

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

Study Sites (1)

Clinique universitaires saint luc

Brussels, 1200, Belgium

Location

Related Publications (5)

• 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

• 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

• 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

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the intensive care unit

Model Details: Group A (n=10): 400mg/d of Bacopa monnieri Broup B (n=10): 800 mg/d of Bacopa monnieri

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: March 15, 2022
• Primary Completion: May 25, 2022
• Study Completion: September 30, 2022
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)