Oxidative StressBacoxy_INCT06355167
Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress
A study testing Bacopa monnieri in people with Oxidative Stress and Cardiovascular Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Cardiovascular Diseases, Bacopaside II
- What is being tested?
- Bacopa monnieri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Effective contraception
Who cannot join
- Any chronic disease
- Any chronic use of drug
- Pregnancy and breast feeding
- Gastro-intestinal diseases (e.g. ulcer, gastro-oesophageal reflux, lactose intolerance)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress.
Read the detailed description
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).
- Conditions
- Oxidative Stress, Cardiovascular Diseases, Bacopaside II, Bacopa Monnieri, Endothelial Dysfunction, Aquaporin 1
- Being tested
- Bacopa monnieri
- Keywords
- vascular oxidative stress, aquaporin 1, AQP1, hydrogen peroxide, cardiovascular diseases, Bacopa monnieri, Bacopaside II, endothelial dysfunction
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacopa monnieriDietary supplement
Also called Bacopa-400
Daily oral intake of Bacopa monnieri during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 dose: 1 capsule of Bacopa monnieri (400mg) | Other | Group A: 400mg/d of Bacopa monnieri Receives: Dietary Supplement: Bacopa monnieri |
| 2 doses: 2 capsules of Bacopa monnieri (800mg) | Other | Group B: 800 mg/d of Bacopa monnieri Receives: Dietary Supplement: Bacopa monnieri |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: Baseline (V0), 6 weeks (V4), 10 weeks (V6)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Mar 2022
- Primary completion25 May 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (n=10): 400mg/d of Bacopa monnieri Broup B (n=10): 800 mg/d of Bacopa monnieri
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montiel Virginie, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355167
- Sponsor's protocol ID
- Bacoxy_I
- Acronym
- Bacoxy_I
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33028705Montiel 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.
PubMed 23873354Pravina 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.
PubMed 17442556Stough 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.
PubMed 18683852Dave 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.
PubMed 24682000
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06355167
- Acronym / sponsor ID
- Bacoxy_I / Bacoxy_I
- Conditions
- Oxidative Stress, Cardiovascular Diseases, Bacopaside II, Bacopa Monnieri, Endothelial Dysfunction, Aquaporin 1
- Keywords
- vascular oxidative stress, aquaporin 1, AQP1, hydrogen peroxide, cardiovascular diseases, Bacopa monnieri, Bacopaside II, endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A (n=10): 400mg/d of Bacopa monnieri Broup B (n=10): 800 mg/d of Bacopa monnieri
| Arm | Type | Receives |
|---|---|---|
| 1 dose: 1 capsule of Bacopa monnieri (400mg) | Other | Dietary Supplement: Bacopa monnieriGroup A: 400mg/d of Bacopa monnieri |
| 2 doses: 2 capsules of Bacopa monnieri (800mg) | Other | Dietary Supplement: Bacopa monnieriGroup B: 800 mg/d of Bacopa monnieri |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Effective contraception
Key exclusion criteria (4 listed)
- Any chronic disease
- Any chronic use of drug
- Pregnancy and breast feeding
- Gastro-intestinal diseases (e.g. ulcer, gastro-oesophageal reflux, lactose intolerance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacopa monnieriAlso: Bacopa-400Daily oral intake of Bacopa monnieri during 6 weeks | Dietary supplement | 1 dose: 1 capsule of Bacopa monnieri (400mg), 2 doses: 2 capsules of Bacopa monnieri (800mg) |
Primary outcome
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.
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).
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.
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
15 secondary outcomes
haemoglobin
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
haematocrit
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Red blood cells count
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Sodium
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Potassium
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Bicarbonate
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Total cholesterol
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
High-Density Lipoprotein (HDL) cholesterol
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Low-Density Lipoprotein (LDL) cholesterol
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Triglycerides
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
aspartate aminotransferase (ASAT), (U/L)
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
alanine aminotransferase (ALAT) (U/L)
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
gamma-glutamyl-transferase (GGT) level
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Creatinine
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Glomerular filtration rate
Time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 33028705Montiel 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.
- Background: PubMed 23873354Montiel 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.
- Background: PubMed 17442556Pravina 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.
- Background: PubMed 18683852Stough 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.
- Background: PubMed 24682000Dave 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacopa monnieri in people with Oxidative Stress and Cardiovascular Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ex vivo DCFDA test on red blood cells (RBCs) (time frame: Baseline (V0), 2 weeks (V2), 6 weeks (V4), 10 weeks (V6)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355167, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.