Oxidative StressBacoxy_IINCT06059131
Effect of a Specific Aquaporin-1 Inhibitor on Vascular Oxidative Stress in Healthy Volunteers
A study testing KeenMind 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_II study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, KeenMind®, on vascular oxidative stress. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Cardiovascular Diseases, Bacopaside II
- What is being tested?
- KeenMind
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jan 2023to 31 Oct 2023
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- any chronic disease
- use of chronic drugs or food supplements
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Bacoxy_II study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, KeenMind®, on vascular oxidative stress.
Read the detailed description
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.
- Conditions
- Oxidative Stress, Cardiovascular Diseases, Bacopaside II, Bacopa Monnieri, Endothelial Dysfunction, Aquaporin 1
- Being tested
- KeenMind, Placebo
- Keywords
- vascular oxidative stress, aquaporin 1, AQP1, peroxiporin, H2O2, 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.
KeenMindOther
Also called Bacopa monnieri
320 mg/d (2 capsules/d) during 3 months
PlaceboOther
320 mg/d (2 capsules/d) during 3 months
| Study group | Role | What they receive |
|---|---|---|
| KeenMind | Experimental | Not described Receives: Other: KeenMind |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
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 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
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Nitrosylated hemoglobin (HbNO)
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.
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Lipid peroxydes
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.
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
EndoPAT
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.
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Secondary outcomes (9)
C-reactive protein (CRP)
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.
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Blood count
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).
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Ion count
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).
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Lipid count
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).
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Liver function
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).
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Kidney function
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).
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
HOMA index
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.
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Body mass index, fat mass, lean mass,
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 (%).
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Waist and hip circumference ratio
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.
Measured: Baseline (V0), 3 months (V1), 4 months (V2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start3 Jan 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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
- 2 arms : placebo vs verum
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Virginie Montiel, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059131
- Sponsor's protocol ID
- 2023/11JAN/014
- Acronym
- Bacoxy_II
- Status last verified
- Apr 2024
- First submitted
- 1 Aug 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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 24682000Montiel 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 23873354Montiel 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 33028705
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06059131
- Acronym / sponsor ID
- Bacoxy_II / 2023/11JAN/014
- Conditions
- Oxidative Stress, Cardiovascular Diseases, Bacopaside II, Bacopa Monnieri, Endothelial Dysfunction, Aquaporin 1
- Keywords
- vascular oxidative stress, aquaporin 1, AQP1, peroxiporin, H2O2, hydrogen peroxide, cardiovascular diseases, Bacopa monnieri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Sep 2023 (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_II study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, KeenMind®, on vascular oxidative stress.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2 arms : placebo vs verum
| Arm | Type | Receives |
|---|---|---|
| KeenMind | Experimental | Other: KeenMind |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (3 listed)
- any chronic disease
- use of chronic drugs or food supplements
- smoking
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 |
|---|---|---|
| KeenMindAlso: Bacopa monnieri320 mg/d (2 capsules/d) during 3 months | Other | KeenMind |
| Placebo320 mg/d (2 capsules/d) during 3 months | Other | Placebo |
Primary outcome
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
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.
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.
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.
9 secondary outcomes
C-reactive protein (CRP)
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
Blood count
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
Ion count
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
Lipid count
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
Liver function
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
Kidney function
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
HOMA index
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
Body mass index, fat mass, lean mass,
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
Waist and hip circumference ratio
Time frame: Baseline (V0), 3 months (V1), 4 months (V2)
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 30 Apr 2024.
- 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.
- 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 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.
- 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.
Virginie Montiel, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KeenMind 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 1 inclusion and 3 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 30 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. Some participants in this study may receive a placebo. 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), 3 months (V1), 4 months (V2)). 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 NCT06059131, 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 30 Apr 2024.