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Trial registered on ANZCTR


Registration number
ACTRN12617001101370
Ethics application status
Approved
Date submitted
25/07/2017
Date registered
28/07/2017
Date last updated
2/08/2019
Date data sharing statement initially provided
2/08/2019
Date results information initially provided
2/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the Therapeutic Effects of Bacopa monnieri Supplementation and Cognitive Training on Brain Health, Cognition and Everyday Function in Healthy Older Adults.
Scientific title
Examining the Neurocognitive Effects of Bacopa monnieri Supplementation and Cognitive Training in Healthy Older Adults
Secondary ID [1] 292528 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive function 304177 0
brain function 304178 0
brain health 304179 0
mood 304180 0
Condition category
Condition code
Alternative and Complementary Medicine 303504 303504 0 0
Other alternative and complementary medicine
Mental Health 303505 303505 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 303506 303506 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be asked to complete 3 1-hour sessions of computerised cognitive training in their home per week (BrainHQ exercises developed by Posit Science) for a 12-week period. The cognitive training battery includes 6 different tasks aimed to improve participants’ memory, reaction time and attention for aural and visually presented stimuli. Tasks include:

- making judgements about stimuli features
- discriminating between similar stimuli
- matching pairs of stimuli
- remembering the order and sequences of presented stimuli
- following instructions
- reconstructing a narrative sequence

Access to these tasks is through an online portal, which will allow researchers to monitor participant progress and compliance.

In addition to the cognitive training, participants will also be randomly allocated to take one of two supplement treatments during the same 12 week period:

- Bacopa monnieri (Flordis KeenMind 160mg, each capsule containing Bacopa monnieri equivalent to dry whole plant 2.16g) to take two capsules every morning with breakfast (total dosage per day 320mg).

-2 placebo capsules containing an inert plant cellulose fibre

To monitor treatment adherence, participants will be asked to complete a treatment taking log during the 12 weeks, in which they are required to tick off each time they take a capsule. In addition, they will be asked to return all left over treatments for a researcher to calculate compliance based on the amount of unused capsules.
Intervention code [1] 298717 0
Treatment: Other
Comparator / control treatment
Placebo containing no active ingredients, matched for appearance, taste and smell to the active treatments. Both participants taking active and placebo treatments will undergo cognitive training.
Control group
Placebo

Outcomes
Primary outcome [1] 302881 0
Changes in brain tissue microstructure as measured by Magnetic Resonance Imaging (MRI) using Diffusion Weighted Imaging (DWI) techniques.
Timepoint [1] 302881 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [1] 337296 0
Changes in BOLD signal as measured by resting state functional MRI.
Timepoint [1] 337296 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [2] 337297 0
Changes in gray matter volume as measured by T1 weighted MRI.
Timepoint [2] 337297 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [3] 337382 0
Changes in markers of inflammation as measured by blood serum concentrations of:
-Tumour Necrosis Factor-a (TMF-a)
-Interleukin-6 (IL-6)
Timepoint [3] 337382 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [4] 337383 0
Changes in markers of brain growth and health as measured by serum blood concentrations of:
- Brain Derived Neurotrophic Factor (BDNF)
- Neuron Specific Enolase (NSE)
- Nerve Growth Factor (NGF)
- S100 calcium-binding protein B (S100B).
Timepoint [4] 337383 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [5] 337386 0
Cognitive function as measured by changes in accuracy score and reaction time for:
- Immediate Recall, Delayed Recall and Recognition Word tasks (recall and recognition of previously presented words)
- Pattern Separation task (recognition of previously presented images)
- Simple Reaction time (single reaction to appropriately paired stimuli)
- Choice Reaction time (choice response of two options based on appropriately paired stimuli)
- Digit Vigilance task (single reaction to matched number pairs)
- Spatial Working Memory task (reconstructing an array of stimuli on a 3x3 grid from memory)
- Numeric Working Memory task (identifying a specific series of digits among distractor digits)
Timepoint [5] 337386 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [6] 337387 0
Change in quality of life as measured by the CASP-19.
Timepoint [6] 337387 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [7] 337388 0
Change in subjective every day memory failures as measured by the Prospective and Retrospective Memory Questionnaire (PRMQ).
Timepoint [7] 337388 0
Baseline and 12 weeks after commencement of intervention.
Secondary outcome [8] 337389 0
Change in mood as measures by the Profile of Mood States scale (POMS).
Timepoint [8] 337389 0
Baseline and 12 weeks after commencement of intervention.

Eligibility
Key inclusion criteria
1) Male or female aged 55 years or above
2) Right handed
3) Has regular access to a computer with internet
4) Has corrected to normal vision
5) In good general health
6) Understands and is willing and able to comply with all study procedures
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Unable to understand or comply with testing procedures.

2) Evidence of clinical cognitive impairment as defined by a score of 23 or less in the Mini Mental State Examination (MMSE).

3) Evidence of clinical mood disturbance as defined by a score of 20 or more in the Beck Depression Inventory-II (BDI-II)

4) Is currently or within the last two years, has been diagnosed with a psychiatric disorder such as major depression, severe anxiety requiring treatment and/or schizophrenia.

5) Is currently diagnosed with a neurological disorder such as Alzheimer’s disease, Parkinson’s disease, stroke, epilepsy, brain tumours, or normal pressure hydrocephalus.

6) Has a history of repeated head injury.

7) Has experienced amnesia with or without loss of consciousness as a result of trauma to the head in the previous 14 days.

8) Has an active infection or sign/symptoms of an infection at V1.

9) Current diagnosis of a health condition which may affect food metabolism such as any inflammatory bowel diseases (e.g. , Crohn’s disease, ulcerative colitis), liver disease, allergies or kidney disease.

10) Has uncontrolled hypertension (systolic blood pressure more than140mmHg, diastolic blood pressure more than 90mmHg).

11) Currently taking supplements/ medication which has shown evidence to have cognitive altering effects and is unwilling to discontinue taking them four weeks prior and during the study period.

12) Female subjects currently pregnant or planning to conceive during the study period.

13) Currently participating in or has participated in another study involving an investigational product in the previous four weeks.

14) Has any implanted metal devices and electronically or magnetically activated devices.

15) Has claustrophobia.

16)Has had an MRI scan in the previous seven days before V1.

17) For blood test results only, significant hypotension before blood test at V1 (systolic blood pressure less than 90mmHg and diastolic blood pressure less than 60mmHg).

18) Currently taking illicit drugs or have a history of substance abuse

19) Currently consuming more than 14 standard alcoholic drinks per week.

20) Is a current smoker.

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 will be stratified to the Bacopa monnieri or placebo group based on their gender. Randomisation will be conducted by personnel who have no other involvement in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
VIC

Funding & Sponsors
Funding source category [1] 297096 0
University
Name [1] 297096 0
Swinburne Alumni, Swinburne University of Technology
Address [1] 297096 0
University Advancement Office
Swinburne University of Technology,
Swinburne Place South, Level 2
24 Wakefield Street, Hawthorn VIC 3122
Country [1] 297096 0
Australia
Funding source category [2] 297097 0
Commercial sector/Industry
Name [2] 297097 0
SFI Research
Address [2] 297097 0
Level 4,
156 Pacific Hwy,
St. Leonards,
NSW 2065
Country [2] 297097 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology, Centre for Human Psychopharmacology
Address
427-451 Burwood Rd,
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 296107 0
None
Name [1] 296107 0
Address [1] 296107 0
Country [1] 296107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298274 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 298274 0
Swinburne University of Technology,
Swinburne Place South, Level 2
24 Wakefield Street, Hawthorn VIC 3122
Ethics committee country [1] 298274 0
Australia
Date submitted for ethics approval [1] 298274 0
03/02/2017
Approval date [1] 298274 0
16/05/2017
Ethics approval number [1] 298274 0
SHR 2017/047

Summary
Brief summary
This study aims to determine if Bacopa monnieri supplementation improves brain health, cognition and well-being in older adults undergoing regular cognitive training. 36 healthy adults aged 55 years or above, will be asked to complete 3 hours of cognitive training at home a week for 12 weeks, while consuming either 320mg of Bacopa monnieri extract or placebo per day. Participants are asked to attend three testing sessions at Swinburne University Hawthorn campus, which includes a screening and practice visit (approx. 2 hours) where consent is obtained, eligibility assessed and participants familiarised with study measures and procedures, and a baseline visit and final visit (3 hours each, 12 weeks apart) where study outcomes are assessed. Procedures measuring treatment efficacy include brain imaging using MRI, blood collection for bio-markers of inflammation and brain health, cognitive assessment of memory, reaction time and attention, and questionnaires assessing mood and everyday functioning.
Trial website
http://www.swinburne.edu.au/research/human-psychopharmacology/clinical-trials/herbal-extract-cognitive-brain-function/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76558 0
Prof Con Stough
Address 76558 0
Centre for Human Psychopharmacology
Swinburne University of Technology
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 76558 0
Australia
Phone 76558 0
+613 9214 8167
Fax 76558 0
Email 76558 0
cstough@swin.edu.au
Contact person for public queries
Name 76559 0
Ms Grace McPhee
Address 76559 0
Centre for Human Psychopharmacology
Swinburne University of Technology
PO Box 218
Mail H99
Hawthorn, VIC, 3122
Country 76559 0
Australia
Phone 76559 0
+613 9214 8229
Fax 76559 0
Email 76559 0
gmcphee@swin.edu.au
Contact person for scientific queries
Name 76560 0
Prof Con Stough
Address 76560 0
Centre for Human Psychopharmacology
Swinburne University of Technology
PO Box 218
Mail H24
Hawthorn, VIC, 3122
Country 76560 0
Australia
Phone 76560 0
+613 9214 8167
Fax 76560 0
Email 76560 0
cstough@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is expected that the results of this trial will be disseminated via peer-reviewed publications and at academic conferences. For these purposes the data will be collated and analysed as group data. If required by the publishing journal, de-identified raw data will be uploaded to an appropriate repository. Otherwise, as the Intellectual Property of this study are owned by SFI and may be used for the purposes of commercialisation of the study product, the trial data will not be made available.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary