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Trial registered on ANZCTR


Registration number
ACTRN12620001331921
Ethics application status
Approved
Date submitted
27/10/2020
Date registered
10/12/2020
Date last updated
10/12/2020
Date data sharing statement initially provided
10/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a herbal supplement on cognition and social behaviour in healthy adults.
Scientific title
Neurocognitive effects of a multiherbal, polyphenol rich supplement for cognition and prosocial behaviour in healthy adults: a randomised controlled trial.
Secondary ID [1] 301953 0
Nil
Universal Trial Number (UTN)
Trial acronym
HrBI2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy adults cognitive function and self reported behaviour 318509 0
Condition category
Condition code
Mental Health 316515 316515 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 316517 316517 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6 week, double blinded, placebo-controlled between conditions (active and placebo supplementation) intervention, which includes 4 weeks of supplementation followed by 2-weeks washout. Participants consume a single, 2 tablet dose (500 mg) daily for 4 weeks of the either the active supplement (herbal combination of Bacopa 300mg, Ginseng 100mg and Coffee fruit extract 100mg) or placebo (microcrystalline cellulose 581mg), followed by 2 weeks (14 days ) of no supplement. Participants will complete three testing points, pre intervention, post supplementation and post wash-out. Adherence will be measured through participant self report and by checking remaining supplement tablets at the post intervention testing session.
Intervention code [1] 318243 0
Treatment: Other
Comparator / control treatment
Placebo (microcrystalline cellulose 581mg)
Control group
Placebo

Outcomes
Primary outcome [1] 324652 0
As a composite primary outcome, a cognitive test battery includes tasks of working memory ( N-back) and attention ( choice reaction time and Stroop). Overall, response time and accuracy scores will be used to provide an estimate of better or worse performance in relation to speed of response post intervention,
Timepoint [1] 324652 0
End of the supplementation and end of 2 weeks washout.
Participants will complete a post intervention assessment after the 4 weeks of supplementation and then again after 2 weeks washout, compared to baseline.
Primary outcome [2] 325872 0
Mood outcome will be assessed through self report, validated questionnaire of depression, anxiety and stress scale ( DASS21). The overall sub scale scores and change from baseline scores will be used.
Timepoint [2] 325872 0
End of the supplementation and end of 2 weeks washout.
Participants will complete a post intervention assessment after the 4 weeks of supplementation and then again after 2 weeks washout, compared to baseline.
Primary outcome [3] 325904 0
Pro-social behaviour composite outcome will be assessed through self report, validated questionnaires that include adult prosociality scale (APS) social safeness scale (SS). The overall score and change from baseline scores will be used.
Timepoint [3] 325904 0
End of the supplementation and end of 2 weeks washout.
Participants will complete a post intervention assessment after the 4 weeks of supplementation and then again after 2 weeks washout, compared to baseline.
Secondary outcome [1] 385341 0
Brain activation through fNIRS ( functional near-infrared spectroscopy) measured during task performance at the three testing sessions ( pre intervention post intervention, and post washout).
Timepoint [1] 385341 0
End of the supplementation and end of 2 weeks washout.
Participants will complete a post intervention assessment after the 4 weeks of supplementation and then again after 2 weeks washout, compared to baseline.
Secondary outcome [2] 385342 0
Brain derived neurotrophic factor (BDNF) - an important protein related to nervous system function will be assessed through blood sample.
Timepoint [2] 385342 0
End of the supplementation and end of 2 weeks washout.
Participants will complete a post intervention assessment after the 4 weeks of supplementation and then again after 2 weeks washout, compared to baseline.
Secondary outcome [3] 389723 0
As a further primary mood outcome, a measure of compassion for self and others (fears of compassion scale FCS) will be used as a self report, validated questionnaire The overall sub scale scores and change from baseline scores will be used.
Timepoint [3] 389723 0
End of the supplementation and end of 2 weeks washout.
Participants will complete a post intervention assessment after the 4 weeks of supplementation and then again after 2 weeks washout, compared to baseline.

Eligibility
Key inclusion criteria
Healthy adults aged 35- 65 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
35 Years
Maximum age
65 Years
Gender
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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes - supplements will be in numbered containers and allocation involves contacting the holder of the
allocation schedule to determine which number container is to be randomly allocated to the participant.
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 studies assessing cognitive changes and fNIRS changes, a minimum of 80 participants (40/group) is required to provide 80% power to detect a 20% change in cognitive -behavioural measures, assuming a standard deviation of 10-20% for outcome measures at an alpha level of 0.05. However, it is proposed that 110 participants be recruited to account for a 20-30% attrition rate of participants during a 4week intervention period. Change from baseline measures with ANOVA will be used to examine between group differences.

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

Funding & Sponsors
Funding source category [1] 306379 0
Commercial sector/Industry
Name [1] 306379 0
USANA Health Sciences Inc
Address [1] 306379 0
3838 West Parkway Boulevard
Salt Lake City, UT 84120
Country [1] 306379 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] 306881 0
University
Name [1] 306881 0
Nanyang Technological University
Address [1] 306881 0
50 Nanyang Avenue, Singapore 639798
Country [1] 306881 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306576 0
Human Research Ethics Committee Central Queensland University
Ethics committee address [1] 306576 0
554-700 Yaamba Rd, Norman Gardens QLD 4701
Ethics committee country [1] 306576 0
Australia
Date submitted for ethics approval [1] 306576 0
29/06/2020
Approval date [1] 306576 0
16/09/2020
Ethics approval number [1] 306576 0
0000022500

Summary
Brief summary
Evidence from scientifc studies demonstrate positive effects of ingredients Ginseng (Cereboost), Bacopa and Coffee fruit extract as isolated components, on various mechanisms that impact cognitive performance and mood. For example, Ginseng
and Gingko have been shown to enhance cognitive performance after acute dosing whilst Bacopa has been shown to have effects primarily with chronic dosing. To date however, the effect of these combined ingredients on cognition, behaviour and brain functioning as a result of chronic dosing has not been evaluated.

The study involves a four-week supplementation period followed by a two-week washout period. Measures of cognitive performance, behaviour, and BDNF levels are undertaken at baseline (presupplementation), postsupplementation (week 4) and at the end of the washout period (week 6) to assess potential supplementation effects on cognitive performance and functioning. This research seeks to understand any changes in cognitive performance and brain activation patterns using standardized cognitive tasks and a non-invasive functional near infrared spectroscopy (fNIRS), measured both before and after taking the active or placebo supplement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104342 0
A/Prof Talitha Best
Address 104342 0
School of Health, Medical and Applied Science
Central Queensland University
160 Ann street, Brisbane QLD 4000
Country 104342 0
Australia
Phone 104342 0
+61732951131
Fax 104342 0
Email 104342 0
t.best@cqu.edu.au
Contact person for public queries
Name 104343 0
A/Prof Talitha Best
Address 104343 0
School of Health, Medical and Applied Science
Central Queensland University
160 Ann street, Brisbane QLD 4000
Country 104343 0
Australia
Phone 104343 0
+61732951131
Fax 104343 0
Email 104343 0
t.best@cqu.edu.au
Contact person for scientific queries
Name 104344 0
A/Prof Talitha Best
Address 104344 0
School of Health, Medical and Applied Science
Central Queensland University
160 Ann street, Brisbane QLD 4000
Country 104344 0
Australia
Phone 104344 0
+61732951131
Fax 104344 0
Email 104344 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 other documents available
Summary results
No Results