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Completed

NCT Number: NCT06355167

Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress

Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique universitaires saint luc

Brussels, 1200, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • Effective contraception

Exclusion criteria

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

Treatment and study plan

Bacopa Monnieri

Dietary Supplement

Daily oral intake of Bacopa monnieri during 6 weeks

Other names: Bacopa-400

Primary outcomes

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

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

    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.

  2. Plasma lipid peroxydes

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

    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).

  3. Methemoglobin in red blood cells

    Time frame: Baseline (V0), 6 weeks (V4), 10 weeks (V6)

    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.

  4. Nitrosylated hemoglobin (HbNO) in red blood cells

    Time frame: Baseline (V0), 6 weeks (V4), 10 weeks (V6)

    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

Secondary outcomes

  1. haemoglobin

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

    The haemoglobin (g/L) is part of hemogram, a quantitative and qualitative analysis of blood constituents. This test was performed to reiterate the known safety of Bacopa monnieri on the systemic circulation after oral ingestion.

  2. haematocrit

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

    The haematocrit (g/L) is part of hemogram, a quantitative and qualitative analysis of blood constituents. This test was performed to reiterate the known safety of Bacopa monnieri on the systemic circulation after oral ingestion.

  3. Red blood cells count

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

    The red blood cells count (10^6/µL) is part of hemogram, a quantitative and qualitative analysis of blood constituents. This test was performed to reiterate the known safety of Bacopa monnieri on the systemic circulation after oral ingestion.

  4. Sodium

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

    Sodium (mM) is part of ion count. Electrolyte concentrations were evaluated to monitor the impact of Bacopa monnieri's diuretic effect on blood ion levels.

  5. Potassium

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

    Potassium (mM) is part of ion count. Electrolyte concentrations were evaluated to monitor the impact of Bacopa monnieri's diuretic effect on blood ion levels.

  6. Bicarbonate

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

    Bicarbonate (mM) is part of ion count. Electrolyte concentrations were evaluated to monitor the impact of Bacopa monnieri's diuretic effect on blood ion levels.

  7. Total cholesterol

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

    Total cholesterol (mg/dL) is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.

  8. High-Density Lipoprotein (HDL) cholesterol

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

    HDL cholesterol (mg/dL), is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.

  9. Low-Density Lipoprotein (LDL) cholesterol

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

    LDL cholesterol (mg/dL) is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.

  10. Triglycerides

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

    Triglycerides (mg/dL) is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.

  11. aspartate aminotransferase (ASAT), (U/L)

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

    ASAT (U/L) was assessed to evaluate the safety of Bacopa monnieri on liver function following oral intake.

  12. alanine aminotransferase (ALAT) (U/L)

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

    ALAT (U/L) was assessed to evaluate the safety of Bacopa monnieri on liver function following oral intake.

  13. gamma-glutamyl-transferase (GGT) level

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

    GGT (U/L) was assessed to evaluate the safety of Bacopa monnieri on liver function following oral intake

  14. Creatinine

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

    Creatinine (mg/dl) was measured to assess the impact of oral intake of Bacopa monnieri on renal function.

  15. Glomerular filtration rate

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

    Glomerular filtration rate (ml/min/m²) was measured to assess the impact of oral intake of Bacopa monnieri on renal function.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study 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

Acronym: Bacoxy_I

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2024
Registry last updated
Apr 10, 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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