HealthyPhase 1NCT02931747
Effect of Bacopa Monnieri on Working Memory and Cognitive Processing in Student
A Phase 1 study testing Bacopa Monnieri 300 mg/day and Bacopa Monnieri 600 mg/day in people with Healthy, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and cognitive processing in student. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bacopa Monnieri 300 mg/day and Bacopa Monnieri 600 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2016to Mar 2017
- Phase
- Phase 1
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy student subject aged between 15-18 years old who studying in the school within Khon Kaen province.
- Body mass index is between 18.5-24.9
Who cannot join
- Subjects who are diagnosed with one of the following: cardiovascular diseases, respiratory disease, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
- Subjects who take any medicine or nutraceuticals or hormone that effect on central nervous system are excluded.
- Alcohol addict or smoking addiction (more than 10 pieces/day)
- Athlete or subjects who have a regular exercise more than 3 times/week
- Subjects who don't follow the instruction during the trial
- Subjects who are participating the other project.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and cognitive processing in student.
Read the detailed description
Learning and working memory are two of the key role for studying and work successful for student particular the high school student who study hard and preparing themselves for the graduate study. The consumption of brain booster product or functional food for improving memory has gained much attention. It has been reported that Bacopa Monnieri could improve learning and working memory in elderly subject by improving the N100 and P300 event related potential. Therefore, Bacopa Monnieri might be the potential product for improving the learning and working memory in student particular high school student.
- Conditions
- Healthy
- Being tested
- Placebo, Bacopa Monnieri 300 mg/day, Bacopa Monnieri 600 mg/day
- Keywords
- Bacopa Monnieri, Working memory, Cognitive processing, Student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Subjects are received Placebo once daily for 16 weeks.
Bacopa Monnieri 300 mg/dayDietary supplement
Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.
Bacopa Monnieri 600 mg/dayDietary supplement
Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects are received the pill of placebo which has same color, shape and smell like the Bacopa Monnieri once daily for 16 weeks. Receives: Dietary Supplement: Placebo |
| Bacopa Monnieri 300 mg/day | Active comparator | Subjects are received the pill of Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks Receives: Dietary Supplement: Bacopa Monnieri 300 mg/day |
| Bacopa Monnieri 600 mg/day | Active comparator | Subjects are received the pill of Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks Receives: Dietary Supplement: Bacopa Monnieri 600 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive processing using the latency of P300 wave
The latency of P300 wave was measured and expressed as millisecond.
Measured: 4 months
Cognitive processing using the amplitude of P300 wave
The amplitude of P300 wave was measured and expressed as micro-volt.
Measured: 4 months
Attention using the latency of N100 wave
The latency of N100 wave was measured and expressed as millisecond.
Measured: 4 months
Attention using the amplitude of N100 wave
The amplitude of N100 wave was measured and expressed as micro-volt.
Measured: 4 months
Secondary outcomes (16)
Accuracy of working memory using computerized battery test
The accuracy of working memory was determined and expressed as percentage.
Measured: 4 months
Speed of working memory using computerized battery test
The speed of working memory was determined and expressed as millisecond.
Measured: 4 months
Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90)
Measured: 4 months
Assessment of mood scale using Bond-Lader visual analogue scales
Measured: 4 months
Acetylcholinesterase activity in serum
Measured: 4 months
Monoamine oxidase activity in serum
Measured: 4 months
Glutamic acid decarboxylase (GAD) activity in serum
Measured: 4 months
Gamma-aminobutyric acid (GABA)-transaminase in serum
Measured: 4 months
Malondialdehyde level in serum
Measured: 4 months
Activity of superoxide dismutase in serum
Measured: 4 month
Activity of catalase in serum
Measured: 4 month
Activity of glutathione peroxidase in serum
Measured: 4 month
Consumption safety of Bacopa Monnieri using electrocardiogram (EKG)
Measured: 4 month
Consumption safety of Bacopa Monnieri using hematological values .
The hematological values including red blood cell, white blood cell, hematocrit and platelet were determined and the data was expressed as number of subject presented with abnormal hematological value.
Measured: 4 month
Consumption safety of Bacopa Monnieri using blood chemistry
The blood chemistry values including renal function test, liver function test, lipid profile, electrolytes and glucose were determined and the data was expressed as number of subject presented with abnormal blood chemistry value.
Measured: 4 month
Consumption safety of Bacopa Monnieri using blood pressure measurement
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- The Government Pharmaceutical Organization
- Responsible party
- Principal investigator, Jintanaporn Wattanathorn, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931747
- Sponsor's protocol ID
- HE581418
- Status last verified
- Aug 2017
- First submitted
- 8 Oct 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bacopa Monnieri on Working Memory and Cognitive Processing in Student
- ClinicalTrials.gov ID
- NCT02931747
- Acronym / sponsor ID
- HE581418
- Conditions
- Healthy
- Keywords
- Bacopa Monnieri, Working memory, Cognitive processing, Student
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- The Government Pharmaceutical Organization
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- 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.
The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and cognitive processing in student.
Detailed description
Learning and working memory are two of the key role for studying and work successful for student particular the high school student who study hard and preparing themselves for the graduate study. The consumption of brain booster product or functional food for improving memory has gained much attention. It has been reported that Bacopa Monnieri could improve learning and working memory in elderly subject by improving the N100 and P300 event related potential. Therefore, Bacopa Monnieri might be the potential product for improving the learning and working memory in student particular high school student.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects are received the pill of placebo which has same color, shape and smell like the Bacopa Monnieri once daily for 16 weeks. |
| Bacopa Monnieri 300 mg/day | Active comparator | Dietary Supplement: Bacopa Monnieri 300 mg/daySubjects are received the pill of Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks |
| Bacopa Monnieri 600 mg/day | Active comparator | Dietary Supplement: Bacopa Monnieri 600 mg/daySubjects are received the pill of Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy student subject aged between 15-18 years old who studying in the school within Khon Kaen province.
- Body mass index is between 18.5-24.9
Key exclusion criteria (6 listed)
- Subjects who are diagnosed with one of the following: cardiovascular diseases, respiratory disease, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
- Subjects who take any medicine or nutraceuticals or hormone that effect on central nervous system are excluded.
- Alcohol addict or smoking addiction (more than 10 pieces/day)
- Athlete or subjects who have a regular exercise more than 3 times/week
- Subjects who don't follow the instruction during the trial
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 |
|---|---|---|
| PlaceboSubjects are received Placebo once daily for 16 weeks. | Dietary supplement | Placebo |
| Bacopa Monnieri 300 mg/daySubjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks. | Dietary supplement | Bacopa Monnieri 300 mg/day |
| Bacopa Monnieri 600 mg/daySubjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks. | Dietary supplement | Bacopa Monnieri 600 mg/day |
Primary outcome
Cognitive processing using the latency of P300 wave
Time frame: 4 months
The latency of P300 wave was measured and expressed as millisecond.
Cognitive processing using the amplitude of P300 wave
Time frame: 4 months
The amplitude of P300 wave was measured and expressed as micro-volt.
Attention using the latency of N100 wave
Time frame: 4 months
The latency of N100 wave was measured and expressed as millisecond.
Attention using the amplitude of N100 wave
Time frame: 4 months
The amplitude of N100 wave was measured and expressed as micro-volt.
16 secondary outcomes
Accuracy of working memory using computerized battery test
Time frame: 4 months
Speed of working memory using computerized battery test
Time frame: 4 months
Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90)
Time frame: 4 months
Assessment of mood scale using Bond-Lader visual analogue scales
Time frame: 4 months
Acetylcholinesterase activity in serum
Time frame: 4 months
Monoamine oxidase activity in serum
Time frame: 4 months
Glutamic acid decarboxylase (GAD) activity in serum
Time frame: 4 months
Gamma-aminobutyric acid (GABA)-transaminase in serum
Time frame: 4 months
Malondialdehyde level in serum
Time frame: 4 months
Activity of superoxide dismutase in serum
Time frame: 4 month
Activity of catalase in serum
Time frame: 4 month
Activity of glutathione peroxidase in serum
Time frame: 4 month
Consumption safety of Bacopa Monnieri using electrocardiogram (EKG)
Time frame: 4 month
Consumption safety of Bacopa Monnieri using hematological values .
Time frame: 4 month
Consumption safety of Bacopa Monnieri using blood chemistry
Time frame: 4 month
Consumption safety of Bacopa Monnieri using blood pressure measurement
Time frame: 4 month
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 18 Aug 2017.
- 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 Phase 1 study testing Bacopa Monnieri 300 mg/day and Bacopa Monnieri 600 mg/day in people with Healthy, run by Khon Kaen University at 1 site in Thailand.
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 6 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 18 Aug 2017. 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 Thailand. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cognitive processing using the latency of P300 wave (time frame: 4 months). 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?
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 18 Aug 2017.