Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001230943
Ethics application status
Approved
Date submitted
24/11/2011
Date registered
1/12/2011
Date last updated
9/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an acute dosage of Bacopa Monniera (brahmi) improve cognition, cardiovascular function and stress in an elderly population
Scientific title
Acute cognitive, cardiovascular and stress effects of
Bacopa Monniera on elderly human participants
Secondary ID [1] 273336 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function in healthy elderly individuals 279100 0
Cardiovascular function in healthy elderly individuals 279101 0
Stress 279102 0
Condition category
Condition code
Alternative and Complementary Medicine 279291 279291 0 0
Herbal remedies
Cardiovascular 279292 279292 0 0
Normal development and function of the cardiovascular system
Mental Health 279293 279293 0 0
Studies of normal psychology, cognitive function and behaviour

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 battery, cardiovascular measures and stress testing) after which they will be administered their randomly assigned treatment. Two hours post dose participant will complete the testing again (cognitive battery, cardiovascular measures and stress testing).


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] 283678 0
Behaviour
Intervention code [2] 283679 0
Prevention
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] 279907 0
Cognitive Function using Cognitive Drug Research (CDR) battery, Swinburne University Computerised Cognitive aging Battery (SUCCAB) battery
Timepoint [1] 279907 0
Baseline and 2hours post dose
Primary outcome [2] 279908 0
Cardiovascular function using transcranial doppler ultrasound and arterial stiffness measure (using sphygmocor system)
Timepoint [2] 279908 0
Baseline and 2hours post dose
Secondary outcome [1] 294746 0
Stress/mood using multitasking battery to induce stress and mood questionnaires before and after stress task
Timepoint [1] 294746 0
Baseline and 2hours post dose

Eligibility
Key inclusion criteria
1.) Healthy non-smoking males and females aged 65 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
65 Years
Maximum age
No limit
Sex
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 (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.
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
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
1/03/2012
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
20
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284159 0
Commercial sector/Industry
Name [1] 284159 0
Soho Flordis International Pty Ltd
Country [1] 284159 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 269117 0
None
Name [1] 269117 0
Nil
Address [1] 269117 0
Nil
Country [1] 269117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286139 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 286139 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 286139 0
Australia
Date submitted for ethics approval [1] 286139 0
Approval date [1] 286139 0
30/05/2011
Ethics approval number [1] 286139 0
SUHREC Project 2009/136 Modification 3

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 battery, cardiovascular measures and stress testing) after which they will be administered their randomly assigned treatment. Two hours post dose participant will complete the testing again (cognitive battery, cardiovascular measures and stress testing).

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 counterbalanced 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
Benson, S., L. A. Downey, C. Stough, M. Wetherell, A. Zangara and A. Scholey (2013). "An Acute, Double-Blind, Placebo-Controlled Cross-over Study of 320mg and 640mg Doses of Bacopa monnieri (CDRI 08) on Multitasking Stress Reactivity and Mood." Phytotherapy Research.
Public notes

Contacts
Principal investigator
Name 33355 0
Prof Con Stough
Address 33355 0
H24, Po Box 218 Hawthorn, Vic, 3122
Country 33355 0
Australia
Phone 33355 0
613 9214 8167
Fax 33355 0
Email 33355 0
[email protected]
Contact person for public queries
Name 16602 0
Mrs Rebecca King
Address 16602 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 16602 0
Australia
Phone 16602 0
613 92145087
Fax 16602 0
Email 16602 0
[email protected]
Contact person for scientific queries
Name 7530 0
Prof Prof Con Stough
Address 7530 0
H24, Po Box 218
Hawthorn, Vic, 3122
Country 7530 0
Australia
Phone 7530 0
613 9214 8167
Fax 7530 0
Email 7530 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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