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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931747
• Other study ID #: HE581418
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2016
• Last updated: August 15, 2017
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Placebo
Subjects are received Placebo once daily for 16 weeks.
• Bacopa Monnieri 300 mg/day
Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.
• Bacopa Monnieri 600 mg/day
Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.

Locations

Country	Name	City	State
Thailand	Jitanaporn Wattanathorn	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
Khon Kaen University	Government Pharmaceutical Organization

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive processing using the latency of P300 wave	The latency of P300 wave was measured and expressed as millisecond.	4 months
Primary	Cognitive processing using the amplitude of P300 wave	The amplitude of P300 wave was measured and expressed as micro-volt.	4 months
Primary	Attention using the latency of N100 wave	The latency of N100 wave was measured and expressed as millisecond.	4 months
Primary	Attention using the amplitude of N100 wave	The amplitude of N100 wave was measured and expressed as micro-volt.	4 months
Secondary	Accuracy of working memory using computerized battery test	The accuracy of working memory was determined and expressed as percentage.	4 months
Secondary	Speed of working memory using computerized battery test	The speed of working memory was determined and expressed as millisecond.	4 months
Secondary	Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90)		4 months
Secondary	Assessment of mood scale using Bond-Lader visual analogue scales		4 months
Secondary	Acetylcholinesterase activity in serum		4 months
Secondary	Monoamine oxidase activity in serum		4 months
Secondary	Glutamic acid decarboxylase (GAD) activity in serum		4 months
Secondary	Gamma-aminobutyric acid (GABA)-transaminase in serum		4 months
Secondary	Malondialdehyde level in serum		4 months
Secondary	Activity of superoxide dismutase in serum		4 month
Secondary	Activity of catalase in serum		4 month
Secondary	Activity of glutathione peroxidase in serum		4 month
Secondary	Consumption safety of Bacopa Monnieri using electrocardiogram (EKG)		4 month
Secondary	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
Secondary	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
Secondary	Consumption safety of Bacopa Monnieri using blood pressure measurement		4 month