Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000810819
Ethics application status
Approved
Date submitted
31/07/2012
Date registered
2/08/2012
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive demand and acute Bacopa monnieri (CDRI08) supplementation
Scientific title
The effects of sustained mental effort upon cardiovascular functioning and stress reactivity in healthy adults: an acute, double-blind, placebo controlled crossover study of 320mg and 640mg doses of a special extract of Bacopa monnieri (CDRI08).
Secondary ID [1] 280940 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 287035 0
Cardiovascular measures (blood pressure, arterial stiffness and cerebral blood flow) 287036 0
Condition category
Condition code
Mental Health 287364 287364 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 287365 287365 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On each testing day, participants consume four capsules containing an inert placebo, 320mg of KeenMind(Registered Trademark) (CDRI 08) BM extract or 640mg of KeenMind (Registered Trademark) (CDRI 08) BM extract. KeenMind (Registered Trademark) (CDRI 08) is standardized for no less than 55% of total bacosides. Each capsule contains 160 mg BM extract (25:1) equivalent to 4 g of dried herb.

Each participant is required to attend a total of 4 sessions (1 practice visit and 3 study visits) that will be conducted one week apart to ensure sufficient washout between each acute condition. Total amount of testing days is 4 weeks (inclusive of practice visit).

There will be three separate testing days where either the placebo, 320 mg of KeenMind (Registered Trademark) or 640 mg of KeenMind (Registered Trademark) will be taken exclusively each day.
Intervention code [1] 285375 0
Treatment: Other
Comparator / control treatment
Placebo (made up of inert plant based materials); identical to active treatments in shape, smell, taste and weight
Control group
Placebo

Outcomes
Primary outcome [1] 287636 0
Cognitive Improvement:
- Rapid visual information processing task (accuracy) - measure of sustained attention, reaction time and false alarm rate
- Serial sevens - measure of concentration and working memory
- Serial Threes - measure of concentration and working memory
Timepoint [1] 287636 0
Baseline, 120 mins post dose
Secondary outcome [1] 298565 0
'Stress and mental fatigue' Visual Analogue Scale (VAS)
Timepoint [1] 298565 0
Baseline, 120 mins post dose
Secondary outcome [2] 298566 0
Cardiovascular measures
- blood pressure
- arterial stiffness
- cerebral blood flow

Brachial blood pressure is calculated in the morning with the participant seated and following a 5 min rest period. All measurements are calculated using an automatic sphygmomanometer, designed for professional use (Omron, 705IT) and validated according to both the European
Hypertension Society (EHS) and the British Hypertension Society (BHS) protocols. Measurements are completed using an appropriately sized cuff by an experienced research assistant and a cardiac technologist. The mean arterial pressure (MAP) is calculated according to the following formula (2 x DBP + SBP)/3. Pulse pressure and augmentation index PP and augmentation index are calculated centrally using a non-invasive device (SphygmoCor; AtCor Medical, Sydney, Australia) by means of applanation tonometry. Through a mathematical transfer function, SphygmoCor derived the ascending aortic waveform from a recording of the radial artery before automatically calculating a range of cardiovascular parameters indicative of arterial stiffness. PP is automatically calculated by deducting the central diastolic pressure from the central systolic pressure whereas central augmentation index is calculated by dividing the augmentation pressure by the PP, multiplied by 100. All recordings are to be completed with the participant sitting down whilst their arm rested on a table with their palm facing upwards.
Timepoint [2] 298566 0
Baseline, 180 mins post dose

Eligibility
Key inclusion criteria
- Non-smoker
- Age between 18 and 56 years
- Healthy (absence of all exclusion criteria) male and female adults
- BMI between 15.40 to 32.74 kg/m2
- Not taking any medication, herbal extracts, vitamin supplements or illicit drugs
- Not pregnant or lactating
- Participants must abstain from caffeine-containing foods/beverages and alcohol for 24 hours prior to the training session and each testing session.
- Written informed consent obtained
Minimum age
18 Years
Maximum age
56 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Smoker
- Existing or pre-existing physical or neurological conditions
- History of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
- Existing chronic illness and infection
- Taking any medication, herbal extracts, vitamin supplements or illicit drugs
- Pregnant or lactating

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants responded to advertisements. After successfully completing a telephone screen, they completed a practice session where they were introduced to the computerised test, passed a brief medical test and informed consent was obtained. They were then given a numerical identification number and was randomly allocated to a treatment series. Participants then returned for 3 testing sessions, receiving a different treatment each visit. The person who determined if a participant was eligible for inclusion in the trial was unaware, when this decision was made, to which group the participant would be allocated. Allocation was concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party performed the randomisation sequence using a Latin Square to ensure a counter-balanced design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Double-blind, placebo-controlled crossover design
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285727 0
Government body
Name [1] 285727 0
Australian Research Council (ARC) Discovery Grant
Country [1] 285727 0
Australia
Funding source category [2] 285728 0
Commercial sector/Industry
Name [2] 285728 0
Soho Flordis International (SFI)
Country [2] 285728 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
Mail H24, PO Box 218,
Hawthorn,
VIC 3122
Country
Australia
Secondary sponsor category [1] 284555 0
None
Name [1] 284555 0
Address [1] 284555 0
Country [1] 284555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287735 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 287735 0
PO Box 218,
Hawthorn,
VIC 3122
Ethics committee country [1] 287735 0
Australia
Date submitted for ethics approval [1] 287735 0
02/09/2011
Approval date [1] 287735 0
26/09/2011
Ethics approval number [1] 287735 0
2009/136

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 a two doses of bacopa compared to placebo.

Participants will be required to consume one of three treatments on each testing day, and will consume the other treatments on the other two days of testing. After the first battery of tests, each participant will be administered their treatment and have a two hour wait period. At the end of this period the participant will complete the second series of battery tests. There will be a seven day washout period and the process will be repeated again.
(1) Bacopa – 320mg
(2) Bacopa – 640mg
(3) Placebo
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34509 0
Address 34509 0
Country 34509 0
Phone 34509 0
Fax 34509 0
Email 34509 0
Contact person for public queries
Name 17756 0
Prof Con Stough
Address 17756 0
Mail H24, PO Box 218,
Swinburne University,
Hawthorn, VIC 3122
Country 17756 0
Australia
Phone 17756 0
+61 3 9214 8167
Fax 17756 0
Email 17756 0
[email protected]
Contact person for scientific queries
Name 8684 0
Prof Con Stough
Address 8684 0
Mail H24, PO Box 218,
Swinburne University,
Hawthorn, VIC 3122
Country 8684 0
Australia
Phone 8684 0
+61 3 9214 8167
Fax 8684 0
Email 8684 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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