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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Bacopa Monnieri 300 mg/day; Dietary supplement: Bacopa Monnieri 600 mg/day

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Jitanaporn Wattanathorn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; Subjects are received Placebo once daily for 16 weeks.
Active Comparator: Bacopa Monnieri 300 mg/day; 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; Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.
Active Comparator: Bacopa Monnieri 600 mg/day; 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; Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: Government Pharmaceutical Organization

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: October 8, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Working memory; Student; Bacopa Monnieri; Cognitive processing
• Other Study ID Numbers: HE581418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No