Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931747
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
Government Pharmaceutical Organization
Information provided by (Responsible Party):
Jintanaporn Wattanathorn, Khon Kaen University

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

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Placebo Dietary Supplement: Bacopa Monnieri 300 mg/day Dietary Supplement: Bacopa Monnieri 600 mg/day Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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.




Primary Outcome Measures :
  1. Cognitive processing using the latency of P300 wave [ Time Frame: 4 months ]
    The latency of P300 wave was measured and expressed as millisecond.

  2. Cognitive processing using the amplitude of P300 wave [ Time Frame: 4 months ]
    The amplitude of P300 wave was measured and expressed as micro-volt.

  3. Attention using the latency of N100 wave [ Time Frame: 4 months ]
    The latency of N100 wave was measured and expressed as millisecond.

  4. Attention using the amplitude of N100 wave [ Time Frame: 4 months ]
    The amplitude of N100 wave was measured and expressed as micro-volt.


Secondary Outcome Measures :
  1. Accuracy of working memory using computerized battery test [ Time Frame: 4 months ]
    The accuracy of working memory was determined and expressed as percentage.

  2. Speed of working memory using computerized battery test [ Time Frame: 4 months ]
    The speed of working memory was determined and expressed as millisecond.

  3. Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90) [ Time Frame: 4 months ]
  4. Assessment of mood scale using Bond-Lader visual analogue scales [ Time Frame: 4 months ]
  5. Acetylcholinesterase activity in serum [ Time Frame: 4 months ]
  6. Monoamine oxidase activity in serum [ Time Frame: 4 months ]
  7. Glutamic acid decarboxylase (GAD) activity in serum [ Time Frame: 4 months ]
  8. Gamma-aminobutyric acid (GABA)-transaminase in serum [ Time Frame: 4 months ]
  9. Malondialdehyde level in serum [ Time Frame: 4 months ]
  10. Activity of superoxide dismutase in serum [ Time Frame: 4 month ]
  11. Activity of catalase in serum [ Time Frame: 4 month ]
  12. Activity of glutathione peroxidase in serum [ Time Frame: 4 month ]
  13. Consumption safety of Bacopa Monnieri using electrocardiogram (EKG) [ Time Frame: 4 month ]
  14. Consumption safety of Bacopa Monnieri using hematological values . [ Time Frame: 4 month ]
    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.

  15. Consumption safety of Bacopa Monnieri using blood chemistry [ Time Frame: 4 month ]
    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.

  16. Consumption safety of Bacopa Monnieri using blood pressure measurement [ Time Frame: 4 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931747


Locations
Layout table for location information
Thailand
Jitanaporn Wattanathorn
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Government Pharmaceutical Organization
Layout table for additonal information
Responsible Party: Jintanaporn Wattanathorn, Associated Professor Doctor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02931747    
Other Study ID Numbers: HE581418
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jintanaporn Wattanathorn, Khon Kaen University:
Bacopa Monnieri
Working memory
Cognitive processing
Student