Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000834853
Ethics application status
Approved
Date submitted
6/08/2012
Date registered
7/08/2012
Date last updated
16/05/2018
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
Nil
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

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) 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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
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-bind, placebo-controlled
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
15/08/2012
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] 285766 0
Government body
Name [1] 285766 0
Australian Research Council (ARC) Discovery Grant
Country [1] 285766 0
Australia
Funding source category [2] 285767 0
Commercial sector/Industry
Name [2] 285767 0
Soho Flordis International (SFI)
Country [2] 285767 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Mail H24, PO Box 218,
Hawthorn,
VIC 3122
Country
Australia
Secondary sponsor category [1] 284594 0
None
Name [1] 284594 0
Address [1] 284594 0
Country [1] 284594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287777 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 287777 0
PO Box 218,
Hawthorn,
VIC 3122
Ethics committee country [1] 287777 0
Australia
Date submitted for ethics approval [1] 287777 0
Approval date [1] 287777 0
03/05/2010
Ethics approval number [1] 287777 0
2009/136

Summary
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

Contacts
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
Australia
Phone 17791 0
+61392148932
Fax 17791 0
Email 17791 0
[email protected]
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
Australia
Phone 8719 0
+61392148932
Fax 8719 0
Email 8719 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.