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Completed

NCT Number: NCT02931747

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.

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Key information

Conditions

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jitanaporn Wattanathorn

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

Subjects are received Placebo once daily for 16 weeks.

Bacopa Monnieri 300 mg/day

Dietary Supplement

Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.

Bacopa Monnieri 600 mg/day

Dietary Supplement

Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • Government Pharmaceutical Organization

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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