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Trial registered on ANZCTR


Registration number
ACTRN12611001234909
Ethics application status
Approved
Date submitted
24/11/2011
Date registered
2/12/2011
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an acute dosage of Bacopa Monniera (brahmi) improve cognition and cardiovascular function in a healthy population
Scientific title
Acute cognitive and cardiovascular effects of
Bacopa Monniera on healthy adults
Secondary ID [1] 273354 0
Nil
Secondary ID [2] 279796 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function in healthy individuals 279127 0
Cardiovascular function in health individuals 279128 0
Condition category
Condition code
Mental Health 279319 279319 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 279320 279320 0 0
Herbal remedies
Cardiovascular 279321 279321 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a double blind, randomised, placebo controlled, three way cross-over design.

Participants will be required to attend three testing sessions (and one practice session). Each session will see participants taking one of three interventions (administered in capsules);

(1) Bacopa Monniera – 300mg (2 x 150mg capsules, 2 x placebo capsules)
(2) Bacopa Monneria – 600mg (4 x 150mg capsules)
(3) Placebo (4 x capsules)

On the testing days participants will complete baseline testing (consisting of the cognitive demand battery and cardiovascular measures) after which they will be administered their randomly assigned treatment. Two hours post dose participants will complete the testing again (cognitive demand battery and cardiovascular)

There will be a seven day washout period between each testing session.

Participants will be randomly allocated to receive either treatment (1) or (2) or (3) on their first testing day. This will be done by a randomised computer number sequence generator. Over the course of the investigation, they will complete all three treatments with treatment order counterbalanced across participants. A disinterested third party will be responsible for the blinding procedure.
Intervention code [1] 283698 0
Prevention
Intervention code [2] 283699 0
Behaviour
Intervention code [3] 283818 0
Treatment: Other
Comparator / control treatment
Treatment (3): 4 X 150mg Avicel microcrystalline cellulose capsules

This is a cross over design, so all participants will be administer all treatments on different testing days separated by a one week wash out period.
Control group
Placebo

Outcomes
Primary outcome [1] 279929 0
Cognitive Function using Cognitive Demand Battery
Timepoint [1] 279929 0
baseline and 2 hours post dose
Primary outcome [2] 279930 0
Cardiovascular function using transcranial doppler ultrasound and arterial stiffness measure (using sphygmocor system)
Timepoint [2] 279930 0
baseline and 2 hours post dose
Secondary outcome [1] 294797 0
nil
Timepoint [1] 294797 0
nil

Eligibility
Key inclusion criteria
1.) Healthy non-smoking males and females aged 18 and over
2.) Free from and no history of psychiatric disorders
3.) No neurological diseases or history of neurological diseases
4.) Not suffering from endocrine, gastrointestinal or bleeding disorders
5.) No history of chronic illness/infection
6.) Not currently pregnant or lactating
7.) Must not be taking any medications or herbal extracts
8.) Must have corrected to normal vision
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.) smoker
2.) history of psychiatric disorders
3.) neurological diseases or history of neurological diseases
4.) endocrine, gastrointestinal or bleeding disorders
5.) history of chronic illness/infection
6.) pregnant or lactating
7.) taking any medications or herbal extracts
8.) vision impairment not corrected

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through advertising and word of mouth. After successfully completing the phone screen, medical screen and practice session, they will be randomly allocated to receive either treatment A or B or C on their first testing day. This will be done by a randomised computer number sequence generator. Over the course of the investigation, they will complete all three treatments with treatment order counterbalanced across participants. A disinterested third party will be responsible for the blinding procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will generate the randomisation sequence using a computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284180 0
Commercial sector/Industry
Name [1] 284180 0
Soho Flordis International Pty Ltd
Address [1] 284180 0
Level 4, 156 Pacific Highway,
St Leonards, NSW 2065
Country [1] 284180 0
Australia
Primary sponsor type
University
Name
Swinburne University of technology
Address
PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 269136 0
None
Name [1] 269136 0
Nil
Address [1] 269136 0
Country [1] 269136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286140 0
Swinburne University Human research Ethics Committee
Ethics committee address [1] 286140 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 286140 0
Australia
Date submitted for ethics approval [1] 286140 0
Approval date [1] 286140 0
26/09/2011
Ethics approval number [1] 286140 0
2009/136 modification 4

Summary
Brief summary
This research project is aiming to determine the effects of Bacopa on cognitive function, cardiovascular function and stress. Bacopa is a herb found in wetlands and muddy shore lines that has been used in traditional Indian medicine as a treatment for epilepsy and asthma. Russo & Borrelli (2005) claim that it has been used for over 3000 years as a memory and intellect enhancer. There is also evidence to suggest that Bacopa is an antioxidant, playing an important role in reducing the oxidation of fats in the bloodstream.

This study will investigate the cognitive, cardiovascular and stress effects of two doses of bacopa compared to placebo.

Participants will be required to attend three testing sessions (and one practice session). Each session will see participants taking one of three interventions (administered in capsules);

(1) Bacopa Monniera – 300mg (2 x 150mg capsules, 2 x placebo capsules)
(2) Bacopa Monneria – 600mg (4 x 150mg capsules)
(3) Placebo (4 x capsules)

On the testing days participants will complete baseline testing (consisting of the Cognitive demand battery and cardiovascular measures) after which they will be administered their randomly assigned treatment. Two hours post dose participant will complete the testing again (Cognitive demand battery and cardiovascular measures).

There will be a seven day washout period and the process will be repeated again.

Over the course of the investigation, participants will complete all three treatments with treatment order being randomised and counter! balanced across participants.

Russo, A. and F. Borrelli (2005). "Bacopa monniera, a reputed nootropic plant: an overview." Phytomedicine 12(4): 305-317.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33370 0
Address 33370 0
Country 33370 0
Phone 33370 0
Fax 33370 0
Email 33370 0
Contact person for public queries
Name 16617 0
Rebecca King
Address 16617 0
H24. PO Box 218
Hawthorn VIC 3122
Country 16617 0
Australia
Phone 16617 0
613 9214 5078
Fax 16617 0
Email 16617 0
rking@swin.edu.au
Contact person for scientific queries
Name 7545 0
Prof Con Stough
Address 7545 0
H24. PO Box 218
Hawthorn VIC 3122
Country 7545 0
Australia
Phone 7545 0
613 9214 8167
Fax 7545 0
Email 7545 0
cstough@swin.edu.au

No data has been provided for results reporting
Summary results
Not applicable