An interventional study of Bacopa monnieri in Oxidative Stress, Cardiovascular Diseases and Bacopaside II, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Prevention
Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress.
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).
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This study's enrollment of 20 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Group A: 400mg/d of Bacopa monnieri
Dietary Supplement: Bacopa monnieri
Group B: 800 mg/d of Bacopa monnieri
Dietary Supplement: Bacopa monnieri
Daily oral intake of Bacopa monnieri during 6 weeks
Also known as: Bacopa-400
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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: Baseline (V0), 6 weeks (V4), 10 weeks (V6)
haemoglobin
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.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
haematocrit
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.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Red blood cells count
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.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Sodium
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.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Potassium
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.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Bicarbonate
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.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Total cholesterol
Total cholesterol (mg/dL) is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
High-Density Lipoprotein (HDL) cholesterol
HDL cholesterol (mg/dL), is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Low-Density Lipoprotein (LDL) cholesterol
LDL cholesterol (mg/dL) is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Triglycerides
Triglycerides (mg/dL) is part of the lipogram, to assess the effect of oral intake of Bacopa monnieri on the lipid metabolism.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
aspartate aminotransferase (ASAT), (U/L)
ASAT (U/L) was assessed to evaluate the safety of Bacopa monnieri on liver function following oral intake.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
alanine aminotransferase (ALAT) (U/L)
ALAT (U/L) was assessed to evaluate the safety of Bacopa monnieri on liver function following oral intake.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
gamma-glutamyl-transferase (GGT) level
GGT (U/L) was assessed to evaluate the safety of Bacopa monnieri on liver function following oral intake
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Creatinine
Creatinine (mg/dl) was measured to assess the impact of oral intake of Bacopa monnieri on renal function.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Glomerular filtration rate
Glomerular filtration rate (ml/min/m²) was measured to assess the impact of oral intake of Bacopa monnieri on renal function.
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Plan to share: No
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain