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Completed

NCT Number: NCT06059131

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

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

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint Luc

Brussels, Belgique, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers

Exclusion criteria

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

Treatment and study plan

KeenMind

Other

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

Other names: Bacopa monnieri

Placebo

Other

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

Primary outcomes

  1. Ex vivo DCFDA test on red blood cells (RBCs)

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    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

  2. Nitrosylated hemoglobin (HbNO)

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    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.

  3. Lipid peroxydes

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    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.

  4. EndoPAT

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    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.

Secondary outcomes

  1. C-reactive protein (CRP)

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    C-reactive protein is a marker of inflammation. unit: mg/L The CRP assesses the inflammatory state of an individual. CRP is measured in the serum after a blood sampling.

  2. Blood count

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    The hemogram is a quantitative and qualitative analysis of blood constituents. This test is performed to reiterate the known safety of Bacopa monnieri on the systemic circulation after oral ingestion. The haemogram includes the following measurements: haemoglobin (g/L), haematocrit (g/L) and red blood cells (10^6/µL).

  3. Ion count

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    As Bacopa monnieri has a diuretic effect, an ionic count will help assess the concentration of electrolytes in the blood. The ion count includes the following measurements: Sodium (mM), potassium (mM), chloride (mM), bicarbonate (mM).

  4. Lipid count

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    To assess the effect of Bacopa monnieri on the lipid profile, we measure blood lipids. Lipids include total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL) and triglycerides (mg/dL).

  5. Liver function

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    Liver function will be assessed to verify the known safety of Bacopa monnieri. Liver function includes: transaminase level (U/L) and gamma-glutamyl-transferase level (U/L).

  6. Kidney function

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    Renal function will be assessed to reiterate the known safety of Bacopa monnieri. Renal function includes the following measurements: creatinine (mg/dl), urea (mg/dl) and glomerular filtration rate (ml/min/m²).

  7. HOMA index

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    The HOMA index will be used to assess changes in insulin sensitivity over the course of the study. The HOMA index is calculated as follows: Fasting blood glucose (mmol/L) * Fasting insulin (mui/mL)/22.5. To calculate this index, we measure fasting blood glucose (mg/dL) and fasting insulin (pmol/L). An index >2.4 is a diagnostic of insulin resistance.

  8. Body mass index, fat mass, lean mass,

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    To assess changes in body composition over the course of the study, we will be using impedance measurement technology. Impedance analysis is used to calculate lean mass (%), fat mass (%) and fluid volume (%).

  9. Waist and hip circumference ratio

    Time frame: Baseline (V0), 3 months (V1), 4 months (V2)

    To assess changes in body composition over the course of the study, we measure waist and hip circumferences. We measure these circumferences using a tape measure in centimetres.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Collaborators

  • Université Catholique de Louvain

Registry information

Official study 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

Acronym: Bacoxy_II

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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