Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000475640
Ethics application status
Approved
Date submitted
27/04/2023
Date registered
10/05/2023
Date last updated
21/07/2024
Date data sharing statement initially provided
10/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the effects of a Bacopa monnieri extract (Bacumen) on cognition and stress in healthy adults: a randomised, double-blind, placebo-controlled trial
Scientific title
An examination into the effects of a Bacopa monnieri extract (Bacumen) on cognition and stress in healthy adults with subjective memory complaints: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 309545 0
None
Universal Trial Number (UTN)
U1111-1291-8534
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 329829 0
Mood disturbance 329830 0
Memory impairment 329831 0
Condition category
Condition code
Neurological 326730 326730 0 0
Other neurological disorders
Alternative and Complementary Medicine 326731 326731 0 0
Herbal remedies
Mental Health 326732 326732 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bacopa monnieri extract (Bacumen) (1 capsule taken orally, twice daily with food, delivering 300 mg a day for 12 weeks). Adherence to capsule intake will be measured by capsule return at week 12.

At baseline and week 12, before any cognitive testing, participants will complete a computerised stress-induction task known as the Multi-tasking Framework (MTF). The MTF is a computer-based, cognitively demanding task where individuals are required to attend and respond to 4 different tasks simultaneously (mental arithmetic, Stroop, visual warning, and number tap)
Intervention code [1] 325970 0
Treatment: Other
Comparator / control treatment
A matching placebo (containing microcrystalline cellulose) in terms of taste and appearance and containing all ingredients except the active ingredient (Bacopa monnieri)
Control group
Placebo

Outcomes
Primary outcome [1] 334593 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 334593 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Primary outcome [2] 334595 0
Change in number of words recalled (comprising 5 immediate recall and 1 delayed recall task) as measured by the Rey Auditory Verbal Learning Test (RAVLT)
Timepoint [2] 334595 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [1] 421326 0
Changes in alertness using the Visual Analog Mood Scale
Timepoint [1] 421326 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement.

At each time point, assessments will be administered: (1) immediately before a stress-induction task, (2) immediately after a stress-induction task, and (3) immediately after cognitive testing.
Secondary outcome [2] 421327 0
Changes in stress using the Visual Analog Mood Scale
Timepoint [2] 421327 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement.

At each time point, assessments will be administered: (1) immediately before a stress-induction task, (2) immediately after a stress-induction task, and (3) immediately after cognitive testing.
Secondary outcome [3] 421328 0
Changes in tranquility using the Visual Analog Mood Scale
Timepoint [3] 421328 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement.

At each time point, assessments will be administered: (1) immediately before a stress-induction task, (2) immediately after a stress-induction task, and (3) immediately after cognitive testing.
Secondary outcome [4] 421329 0
Changes in mental fatigue using a Visual Analogue Scale
Timepoint [4] 421329 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement.

At each time point, assessments will be administered: (1) immediately before a stress-induction task, (2) immediately after a stress-induction task, and (3) immediately after cognitive testing.
Secondary outcome [5] 421330 0
Changes in physical fatigue using a Visual Analogue Scale
Timepoint [5] 421330 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement.

At each time point, assessments will be administered: (1) immediately before a stress-induction task, (2) immediately after a stress-induction task, and (3) immediately after cognitive testing.
Secondary outcome [6] 421331 0
Changes in the total score on the Everyday Memory Questionnaire - Revised
Timepoint [6] 421331 0
Day 0 (pre-commencement of intervention), weeks 4, 8, and 12 post-intervention commencement
Secondary outcome [7] 421332 0
Changes in the total score on the Perceived Stress Reactivity Scale
Timepoint [7] 421332 0
Day 0 (pre-commencement of intervention), weeks 4, 8, and 12 post-intervention commencement
Secondary outcome [8] 421333 0
Changes in the total score on the World Health Organisation (WHO) - 5 Wellbeing Index
Timepoint [8] 421333 0
Day 0 (pre-commencement of intervention), weeks 4, 8, and 12 post-intervention commencement
Secondary outcome [9] 421334 0
Change in blood concentrations of Brain-Derived Neurotrophic Factor (BDNF)
Timepoint [9] 421334 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [10] 421335 0
Change in blood concentrations of Malondialdehyde (MDA)
Timepoint [10] 421335 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [11] 421336 0
Change in blood concentrations of Acetylcholinesterase (AChE)
Timepoint [11] 421336 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement

Eligibility
Key inclusion criteria
1. Healthy individuals (male and female) aged between 40 to 70 years
2. Residing in independent living accommodation
3. Subjective report of memory or attention problems by answering ‘yes’ to the following question: Do you have problems with your memory, attention, or concentration?
4. Non-smoker
5. BMI between 18 and 35 kg/m2
6. No plan to commence new treatments over the study period
7. Understand, willing and able to comply with all study procedures
8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria
2. A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
3. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy
4. Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease)
5. History of paralysis, stroke or seizures or head injury (with loss of consciousness).
6. Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, or steroid medications.
7. Change in medication in the last 3 months or an expectation to change during the study duration
8. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
9. In the last 6 months, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcome
10. Alcohol intake greater than 14 standard drinks per week
11. Current or 12-month history of illicit drug abuse
12. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant.
13. Any significant surgeries over the last year
14. Planned major lifestyle change in the next 3 months

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)
Allocation is concealed through the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by computer software
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
In randomised, double-blind, placebo-controlled trials examining the effects of Bacopa monnieri in middle-to-older age adults, effect sizes of 0.4 to 0.8 after 8 to 12 weeks of supplementation were identified on cognitive tasks such as the Rey Auditory Verbal Learning Test (RAVLT) and computer-based tests of working memory. If we assume an effect size of 0.6, a power of 80%, and a type one error rate (alpha) of 5%, the total number of participants to find an effect is 72. Assuming a 15% dropout rate, a recruited sample size of 100 participants will give suitable power to find a statistically-significant effect compared to the placebo, even after dropouts.

Data will be analysed from day 0 to week 12 using Generalised Linear Mixed Models (GLMM) with intervention effects assessed by intervention group (placebo and Bacopa monnieri) x time interaction.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2023
Actual
29/05/2023
Date of last participant enrolment
Anticipated
29/02/2024
Actual
14/02/2024
Date of last data collection
Anticipated
21/06/2024
Actual
14/05/2024
Sample size
Target
100
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313735 0
Commercial sector/Industry
Name [1] 313735 0
US Pharma Lab
Country [1] 313735 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Road Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 315550 0
None
Name [1] 315550 0
Address [1] 315550 0
Country [1] 315550 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312907 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 312907 0
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 312907 0
Australia
Date submitted for ethics approval [1] 312907 0
11/09/2022
Approval date [1] 312907 0
09/11/2022
Ethics approval number [1] 312907 0
0112E_2022

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 adults aged 40 to 70 years with self-reported memory complaints will be randomly assigned to receive capsules containing either a Bacopa Monnieri extract (Bacumen) (150mg twice daily) or a placebo for 12 weeks. We will assess changes in cognitive performance, mood, and fatigue using self-report questionnaires. Changes in blood markers associated with neuronal activity (brain-derived neurotrophic factor and acetylcholinesterase) and free radical damage (Malondialdehyde will be assessed over time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126294 0
Dr Adrian Lopresti
Address 126294 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 126294 0
Australia
Phone 126294 0
+61 8 94487376
Fax 126294 0
Email 126294 0
[email protected]
Contact person for public queries
Name 126295 0
Adrian Lopresti
Address 126295 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 126295 0
Australia
Phone 126295 0
+61 8 94487376
Fax 126295 0
Email 126295 0
[email protected]
Contact person for scientific queries
Name 126296 0
Adrian Lopresti
Address 126296 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 126296 0
Australia
Phone 126296 0
+61 8 94487376
Fax 126296 0
Email 126296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.