Clinical trial NCT02931747: Effect of Bacopa Monnieri on Working Memory and Cognitive Processing in Student
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bacopa Monnieri
Working memory
Cognitive processing
Student
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Government Pharmaceutical Organization
First posted: 2016-10-13
Enrollment: 75
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive processing using the latency of P300 wave
timeFrame: 4 months
measure: Cognitive processing using the amplitude of P300 wave
timeFrame: 4 months
measure: Attention using the latency of N100 wave
timeFrame: 4 months
measure: Attention using the amplitude of N100 wave
timeFrame: 4 months
Secondary outcomes:
measure: Accuracy of working memory using computerized battery test
timeFrame: 4 months
measure: Speed of working memory using computerized battery test
timeFrame: 4 months
measure: Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90)
timeFrame: 4 months
measure: Assessment of mood scale using Bond-Lader visual analogue scales
timeFrame: 4 months
measure: Acetylcholinesterase activity in serum
timeFrame: 4 months
measure: Monoamine oxidase activity in serum
timeFrame: 4 months
measure: Glutamic acid decarboxylase (GAD) activity in serum
timeFrame: 4 months
measure: Gamma-aminobutyric acid (GABA)-transaminase in serum
timeFrame: 4 months
measure: Malondialdehyde level in serum
timeFrame: 4 months
measure: Activity of superoxide dismutase in serum
timeFrame: 4 month
measure: Activity of catalase in serum
timeFrame: 4 month
measure: Activity of glutathione peroxidase in serum
timeFrame: 4 month
measure: Consumption safety of Bacopa Monnieri using electrocardiogram (EKG)
timeFrame: 4 month
measure: Consumption safety of Bacopa Monnieri using hematological values .
timeFrame: 4 month
measure: Consumption safety of Bacopa Monnieri using blood chemistry
timeFrame: 4 month
measure: Consumption safety of Bacopa Monnieri using blood pressure measurement
timeFrame: 4 month
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Jitanaporn Wattanathorn
Study officials:
References: