Effect of Bacopa Monnieri on Working Memory and Cognitive Processing in Student

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and cognitive processing in student.

Detailed Description
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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
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Healthy

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Bacopa Monnieri 300 mg/day
* Dietary Supplement: Bacopa Monnieri 600 mg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects are received the pill of placebo which has same color, shape and smell like the Bacopa Monnieri once daily for 16 weeks. | Dietary Supplement: Placebo<br>* Subjects are received Placebo once daily for 16 weeks.<br>|
| Active Comparator: Bacopa Monnieri 300 mg/day<br>Subjects are received the pill of Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks | Dietary Supplement: Bacopa Monnieri 300 mg/day<br>* Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.<br>|
| Active Comparator: Bacopa Monnieri 600 mg/day<br>Subjects are received the pill of Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks | Dietary Supplement: Bacopa Monnieri 600 mg/day<br>* Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive processing using the latency of P300 wave | The latency of P300 wave was measured and expressed as millisecond. | 4 months | 
| Cognitive processing using the amplitude of P300 wave | The amplitude of P300 wave was measured and expressed as micro-volt. | 4 months | 
| Attention using the latency of N100 wave | The latency of N100 wave was measured and expressed as millisecond. | 4 months | 
| Attention using the amplitude of N100 wave | The amplitude of N100 wave was measured and expressed as micro-volt. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of working memory using computerized battery test | The accuracy of working memory was determined and expressed as percentage. | 4 months | 
| Speed of working memory using computerized battery test | The speed of working memory was determined and expressed as millisecond. | 4 months | 
| Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90) |  | 4 months | 
| Assessment of mood scale using Bond-Lader visual analogue scales |  | 4 months | 
| Acetylcholinesterase activity in serum |  | 4 months | 
| Monoamine oxidase activity in serum |  | 4 months | 
| Glutamic acid decarboxylase (GAD) activity in serum |  | 4 months | 
| Gamma-aminobutyric acid (GABA)-transaminase in serum |  | 4 months | 
| Malondialdehyde level in serum |  | 4 months | 
| Activity of superoxide dismutase in serum |  | 4 month | 
| Activity of catalase in serum |  | 4 month | 
| Activity of glutathione peroxidase in serum |  | 4 month | 
| Consumption safety of Bacopa Monnieri using electrocardiogram (EKG) |  | 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. | 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. | 4 month | 
| Consumption safety of Bacopa Monnieri using blood pressure measurement |  | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacopa Monnieri, Working memory, Cognitive processing, Student