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Trial registered on ANZCTR


Registration number
ACTRN12613001084774
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
26/09/2013
Date last updated
17/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of acute Bacopa Monnieri (CDRI08) supplementation on sustained cognitive performance and mood
Scientific title
An acute, double blind, placebo-controlled crossover study of 320mg, 640mg and 960mg doses of a special extract of Bacopa Monnieri (CDRI08) on sustained cognitive performance and mood in healthy adults
Secondary ID [1] 283314 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 290200 0
Mood and stress reactivity 290201 0
Condition category
Condition code
Mental Health 290593 290593 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 290594 290594 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On each testing day, participants consume six identical capsules containing either an inert placebo, 320mg of KeenMind (Registered Trademark) (CDRI 08) Bacopa Monnieri (BM) extract or 640mg of KeenMind (Registered Trademark) (CDRI 08) BM extract or 960mg of KeenMind (Registered Trademark) (CDRI08) BM extract. The Bacopa treatment used will be standardized. Bacosides A and B must be present and account for at least 55% of the product. Each capsule contains 160 mg BM extract.

Each participant is required to attend a total of 5 sessions (1 practice visit and 4 study visits) that will be conducted one week apart to ensure sufficient washout between each acute condition. Total amount of testing days is 5 weeks (inclusive of practice visit).

There will be four separate testing days where either the placebo, 320 mg of KeenMind (Registered Trademark) or 640 mg of KeenMind (Registered Trademark) or 960 mg of KeenMind (Registered Trademark) will be taken exclusively each day.
Intervention code [1] 288033 0
Treatment: Other
Comparator / control treatment
The placebo capsules will match the Bacopa ones in almost every way; except it will only contain flour. Otherwise, their colour, smell, weight and size will all be matched with the capsules used in the other study arm.
Control group
Placebo

Outcomes
Primary outcome [1] 290604 0
Overall cognition using PURPLE multitasking framework
Timepoint [1] 290604 0
Baseline, 1 hour post dose, 2 hours post dose, 4 hours post dose
Secondary outcome [1] 304889 0
Mood (Bond-Lader Visual Analogue Scales, Stress and Fatigue Visual Analogue Mood Scales & STAI-S)
Timepoint [1] 304889 0
Baseline, 1 hour post dose, 2 hours post dose, 4 hours post dose
Secondary outcome [2] 304900 0
Task Specific Cognition (Mental Arithmetic, Stroop, Letter Search and Visual Tracking)
Timepoint [2] 304900 0
Baseline, 1 hour post dose, 2 hours post dose, 4 hours post dose

Eligibility
Key inclusion criteria
- Non-smoker
- Age between 18 and 55 years
- Healthy (absence of all exclusion criteria) male and female adults
- Not taking any medication, herbal extracts, 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
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Smoker
- Heavy regular use of alcohol (more than 14 standard drinks per week)
- 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, dietary supplements (which may influence cognitive or mood) 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 4 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?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/08/2013
Actual
27/08/2013
Date of last participant enrolment
Anticipated
1/10/2013
Actual
11/11/2013
Date of last data collection
Anticipated
Actual
4/12/2013
Sample size
Target
35
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7384 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 288046 0
Commercial sector/Industry
Name [1] 288046 0
Soho Flordis International
Country [1] 288046 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] 286770 0
None
Name [1] 286770 0
Address [1] 286770 0
Country [1] 286770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289969 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 289969 0
PO Box 218, Hawthorn VIC 3122
Ethics committee country [1] 289969 0
Australia
Date submitted for ethics approval [1] 289969 0
Approval date [1] 289969 0
16/07/2013
Ethics approval number [1] 289969 0
SUHREC 2013/144

Summary
Brief summary
The primary objective of the current study is to replicate a recent study conducted in our centre (Benson et al., 2013) in order to confirm these results and to provide further data on the acute cognitive effects of an extract of Bacopa (KeenMind). The secondary objective of the study is to extend upon the study by Benson et al. (2013) by examining a wider range of doses to ascertain whether there is a dose-response relationship between KeenMind and cognition.

The study will be an acute, 4-arm, randomised, double-blind, placebo-controlled crossover design. Participants will attend 4 testing sessions (and 1 practice session) where they will complete cognitive, mood and stress assessments, prior to and 1, 2 and 4 hours post supplementation.

The participant group will be healthy adults aged between 18-55yrs, who are able to commit to five visits to Swinburne University to attend testing sessions. Participants will not be taking any supplements or medications and have no current medical or psychiatric diagnosis.

Participants will orally consume each treatment one occasion, directly after a light meal. Each treatment will be administered after a 1 week wash out period.
Treatment 1 – Placebo
Treatment 2 – 320mg KeenMind
Treatment 3 – 640mg KeenMind
Treatment 4 – 960mg KeenMind
Trial website
Trial related presentations / publications
None.
Public notes

Contacts
Principal investigator
Name 43318 0
Prof Con Stough
Address 43318 0
Centre for Human Psychopharmacology,
Mail H24, PO Box 218,
Swinburne University of Technology,
Hawthorn VIC 3122
Country 43318 0
Australia
Phone 43318 0
+61392148167
Fax 43318 0
Email 43318 0
[email protected]
Contact person for public queries
Name 43319 0
Antionette Goh
Address 43319 0
Centre for Human Psychopharmacology,
Mail H24, PO Box 218,
Swinburne University of Technology,
Hawthorn VIC 3122
Country 43319 0
Australia
Phone 43319 0
+61392145094
Fax 43319 0
Email 43319 0
[email protected]
Contact person for scientific queries
Name 43320 0
Con Stough
Address 43320 0
Centre for Human Psychopharmacology,
Mail H24, PO Box 218,
Swinburne University of Technology,
Hawthorn VIC 3122
Country 43320 0
Australia
Phone 43320 0
+61392148167
Fax 43320 0
Email 43320 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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