Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001425189
Ethics application status
Approved
Date submitted
30/09/2019
Date registered
15/10/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Date results provided
15/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Herbs, Brain Imaging and Memory study.
Scientific title
Acute neurocognitive effects of Bacopa, Ginseng and Whole Coffee Fruit in healthy adults
Secondary ID [1] 299416 0
none
Universal Trial Number (UTN)
Trial acronym
HrBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 314593 0
Condition category
Condition code
Mental Health 312931 312931 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 313156 313156 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An acute (same day), double-blinded, placebo-controlled between conditions (active and placebo supplementation) intervention, where participants consume a single, 2 tablet dose (500mg) in a 2 hr period of either the active (herbal combination of Bacopa 300mg, Ginseng 100mg, and Coffee fruit extract 100mg) or placebo (microcrystalline cellulose 581mg).
Participants complete a series of thinking and memory tasks pre and post consumption.
Tolerance to tablet consumption was monitored through direct observation by study personnel and through a specific tolerance question, " how are you feeling now?".
Intervention code [1] 315665 0
Treatment: Other
Comparator / control treatment
Placebo - microcrystalline cellulose
Control group
Placebo

Outcomes
Primary outcome [1] 321555 0
As a composite primary outcome, a cognitive test battery included tasks of working memory ( N-back) and attention ( choice reaction time and Stroop). Overall, response time and accuracy scores were used to provide an estimate of better or worse performance in relation to speed of response.
Timepoint [1] 321555 0
Single, same day testing in which participants complete two assessments within a 2 hour timeframe: a baseline (pre-consumption) assessment and 1 hour post-consumption assessment.
Secondary outcome [1] 375348 0
Brain activation through fNIR ( functional near-infrared spectroscopy) measure during task performance.
Timepoint [1] 375348 0
Single, same day testing in which participants complete two assessments within a 2 hour timeframe: a baseline (pre-consumption) assessment and 1 hour post-consumption assessment.

Eligibility
Key inclusion criteria
Healthy adults aged 18- 60 years, without major medical conditions, such as diabetes,
cardiovascular disease, acute or terminal illness; BMI below 35, moderate alcohol consumption, no medication changes for the management of
health conditions within last 6 weeks, no current or recent history of taking medications for mood disorders and/or previous history of neurological conditions as these conditions have been shown to be related to impaired cognitive performance.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-existing medical conditions, including diabetes, cardiovascular disease, medication changes for the management of health conditions within last 6 weeks, current or recent history of taking medications for mood disorders and/or previous history of neurological conditions.

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)
Yes - supplements were in numbered containers and allocation involved contacting the holder of the allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation schedule created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on sample size calculation from previous acute studies assessing cognitive changes and fNIRS changes, a minimum of 40 participants (20/group) is required. Change from baseline measures with ANOVA used to examine between group differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/02/2019
Date of last participant enrolment
Anticipated
Actual
14/03/2019
Date of last data collection
Anticipated
Actual
18/03/2019
Sample size
Target
50
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303923 0
Commercial sector/Industry
Name [1] 303923 0
USANA Health Sciences Inc
Country [1] 303923 0
United States of America
Primary sponsor type
University
Name
Central Queensland University
Address
160 Ann Street Brisbane, QLD Australia 4000
Country
Australia
Secondary sponsor category [1] 304074 0
None
Name [1] 304074 0
Address [1] 304074 0
Country [1] 304074 0
Other collaborator category [1] 280980 0
University
Name [1] 280980 0
Nanyang Technological University
Address [1] 280980 0
50 Nanyang Avenue, Singapore 639798
Country [1] 280980 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304424 0
Human Research Ethics Committee Central Queensland University
Ethics committee address [1] 304424 0
Ethics committee country [1] 304424 0
Australia
Date submitted for ethics approval [1] 304424 0
13/11/2018
Approval date [1] 304424 0
18/12/2018
Ethics approval number [1] 304424 0
0000021386

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96910 0
A/Prof Talitha Best
Address 96910 0
School Health Medical and Applied Science
160 Ann street, Brisbane QLD, 4000
Country 96910 0
Australia
Phone 96910 0
+61 7 3295 1131
Fax 96910 0
Email 96910 0
t.best@cqu.edu.au
Contact person for public queries
Name 96911 0
Talitha Best
Address 96911 0
School Health Medical and Applied Science
160 Ann street, Brisbane QLD, 4000
Country 96911 0
Australia
Phone 96911 0
+61 7 3295 1131
Fax 96911 0
Email 96911 0
t.best@cqu.edu.au
Contact person for scientific queries
Name 96912 0
Talitha Best
Address 96912 0
School Health Medical and Applied Science
160 Ann street, Brisbane QLD, 4000
Country 96912 0
Australia
Phone 96912 0
+61 7 3295 1131
Fax 96912 0
Email 96912 0
t.best@cqu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
Following main results publication up to 12 months.
Available to whom?
only researchers who provide a methodologically sound proposal, case-by-case basis.
Available for what types of analyses?
Decided upon relevant request regarding meta analyses or in line with approved aims/intention of the study.
How or where can data be obtained?
Access subject to approval by Principal Investigator, email: t.best@cqu.edu.au or phone +61 7 3295 1131


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
SourceTitleYear of PublicationDOI
EmbaseAcute effects of combined Bacopa, American ginseng and whole coffee fruit on working memory and cerebral haemodynamic response of the prefrontal cortex: a double-blind, placebo-controlled study.2021https://dx.doi.org/10.1080/1028415X.2019.1690288
N.B. These documents automatically identified may not have been verified by the study sponsor.