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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Multi-tasking and acute Bacopa Monnieri (CDRI 08) supplementation
Scientific title
The effects of multi-tasking upon 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] 280983 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 287102 0
Stress 287103 0
Condition category
Condition code
Mental Health 287427 287427 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 287428 287428 0 0
Herbal remedies

Study type
Description of intervention(s) / exposure
On each testing day, participants consume four capsules containing an inert placebo, 320mg of KeenMind(Registered Trademark) (CDRI 08) Bacopa Monnieri (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] 285427 0
Treatment: Other
Comparator / control treatment
Placebo (made up of inert plant based materials); identical to active treatments in shape, smell, taste and weight; will not contain the active ingredient
Control group

Primary outcome [1] 287692 0
Cognitive Assessment using multitasking framework (Purple Research Solutions, UK) where tasks included mental arithmetic, stroop, letter search and visual tracking
Timepoint [1] 287692 0
Baseline, 1 hour and 2 hour post dose
Secondary outcome [1] 298644 0
Mood measure using Bond-Lader Visual Analogue Scale (VAS)
Timepoint [1] 298644 0
Baseline, 1 hour and 2 hour post dose
Secondary outcome [2] 298645 0
Anxiety measure using state anxiety subscale (STAI-S) of the State Trait Anxiety Inventory (STAI)
Timepoint [2] 298645 0
Baseline, 1 hour and 2 hour post dose
Secondary outcome [3] 298646 0
Stress measure using cortisol testing; salivary samples using salivettes are employed to measure cortisol levels. Participants will be asked to place a cotton dental roll in their mouth and chew for approximately 30 seconds. Salivettes are then immediately frozen and then defrosted prior to testing. Testing will be carried out using luminescence immunoassay.
Timepoint [3] 298646 0
Baseline, 1 hour and 2 hour post dose

Key inclusion criteria
- Non-smoker
- Age between 18 and 44 years
- Healthy (absence of all exclusion criteria) male and female adults
- 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
44 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Smoker
- History of psychiatric disorders or neurological diseases
- Suffering from endocrine, gastrointestinal or bleeding disorders
- Taking any medication, herbal extracts, vitamin supplements or illicit drugs
- Pregnant or lactating

Study design
Purpose of the study
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
Other design features
Double-bind, placebo-controlled
Phase 3 / Phase 4
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 285766 0
Government body
Name [1] 285766 0
Australian Research Council (ARC) Discovery Grant
Address [1] 285766 0
GPO Box 2702
ACT 2601
Country [1] 285766 0
Funding source category [2] 285767 0
Commercial sector/Industry
Name [2] 285767 0
Soho Flordis International (SFI)
Address [2] 285767 0
Level 4, 156 Pacific Highway,
St Leonards NSW 2065
Country [2] 285767 0
Primary sponsor type
Swinburne University of Technology
Mail H24, PO Box 218,
VIC 3122
Secondary sponsor category [1] 284594 0
Name [1] 284594 0
Address [1] 284594 0
Country [1] 284594 0

Ethics approval
Ethics application status
Ethics committee name [1] 287777 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 287777 0
PO Box 218,
VIC 3122
Ethics committee country [1] 287777 0
Date submitted for ethics approval [1] 287777 0
Approval date [1] 287777 0
Ethics approval number [1] 287777 0

Brief summary
The aim of this study is to ascertain whether a standard clinical dose of 320 mg or a 640 mg dose of a specific extract of Bacopa Monnieri [KeenMind (Registered Trademark) - CDRI 08] would acutely affect cognition, mood, anxiety and stress at an earlier timepoint than previous Bacopa Monnieri supplementation studies.

This study will investigate the cognitive 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. 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

Principal investigator
Name 34544 0
Address 34544 0
Country 34544 0
Phone 34544 0
Fax 34544 0
Email 34544 0
Contact person for public queries
Name 17791 0
Prof Andrew Scholey
Address 17791 0
Mail H24, PO Box 218,
Swinburne University,
Hawthorn, VIC 3122
Country 17791 0
Phone 17791 0
Fax 17791 0
Email 17791 0
Contact person for scientific queries
Name 8719 0
Prof Andrew Scholey
Address 8719 0
Mail H24, PO Box 218,
Swinburne University,
Hawthorn, VIC 3122
Country 8719 0
Phone 8719 0
Fax 8719 0
Email 8719 0

No information has been provided regarding IPD availability
Summary results
No Results