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Trial registered on ANZCTR
Registration number
ACTRN12623000475640
Ethics application status
Approved
Date submitted
27/04/2023
Date registered
10/05/2023
Date last updated
4/08/2023
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
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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
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Secondary ID [1]
309545
0
None
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Universal Trial Number (UTN)
U1111-1291-8534
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment
329829
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Mood disturbance
329830
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Memory impairment
329831
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Condition category
Condition code
Neurological
326730
326730
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0
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Other neurological disorders
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Alternative and Complementary Medicine
326731
326731
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0
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Herbal remedies
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Mental Health
326732
326732
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
325970
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Treatment: Other
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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)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
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Assessment method [1]
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Timepoint [1]
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Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
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Primary outcome [2]
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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)
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Assessment method [2]
334595
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Timepoint [2]
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Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
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Secondary outcome [1]
421326
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Changes in alertness using the Visual Analog Mood Scale
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Assessment method [1]
421326
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Timepoint [1]
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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.
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Secondary outcome [2]
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Changes in stress using the Visual Analog Mood Scale
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Assessment method [2]
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Timepoint [2]
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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.
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Secondary outcome [3]
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Changes in tranquility using the Visual Analog Mood Scale
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Assessment method [3]
421328
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Timepoint [3]
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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.
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Secondary outcome [4]
421329
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Changes in mental fatigue using a Visual Analogue Scale
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Assessment method [4]
421329
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Timepoint [4]
421329
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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.
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Secondary outcome [5]
421330
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Changes in physical fatigue using a Visual Analogue Scale
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Assessment method [5]
421330
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Timepoint [5]
421330
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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.
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Secondary outcome [6]
421331
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Changes in the total score on the Everyday Memory Questionnaire - Revised
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Assessment method [6]
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Timepoint [6]
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Day 0 (pre-commencement of intervention), weeks 4, 8, and 12 post-intervention commencement
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Secondary outcome [7]
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Changes in the total score on the Perceived Stress Reactivity Scale
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Assessment method [7]
421332
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Timepoint [7]
421332
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Day 0 (pre-commencement of intervention), weeks 4, 8, and 12 post-intervention commencement
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Secondary outcome [8]
421333
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Changes in the total score on the World Health Organisation (WHO) - 5 Wellbeing Index
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Assessment method [8]
421333
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Timepoint [8]
421333
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Day 0 (pre-commencement of intervention), weeks 4, 8, and 12 post-intervention commencement
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Secondary outcome [9]
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Change in blood concentrations of Brain-Derived Neurotrophic Factor (BDNF)
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Assessment method [9]
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Timepoint [9]
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Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
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Secondary outcome [10]
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Change in blood concentrations of Malondialdehyde (MDA)
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Assessment method [10]
421335
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Timepoint [10]
421335
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Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
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Secondary outcome [11]
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Change in blood concentrations of Acetylcholinesterase (AChE)
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Assessment method [11]
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Timepoint [11]
421336
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Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
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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.
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Minimum age
40
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through the use of numbered containers
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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
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
29/05/2023
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Actual
29/05/2023
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Date of last participant enrolment
Anticipated
29/02/2024
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Actual
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Date of last data collection
Anticipated
21/06/2024
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Actual
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Sample size
Target
100
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
313735
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Commercial sector/Industry
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Name [1]
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US Pharma Lab
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Address [1]
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1300 Airport Road, North Brunswick, NJ 08902
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Clinical Research Australia
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Address
38 Arnisdale Road Duncraig WA 6023
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
315550
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Country [1]
315550
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312907
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National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
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Ethics committee address [1]
312907
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11-23 Burwood Rd Hawthorn VIC 3122
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Ethics committee country [1]
312907
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Australia
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Date submitted for ethics approval [1]
312907
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11/09/2022
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Approval date [1]
312907
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09/11/2022
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Ethics approval number [1]
312907
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0112E_2022
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Adrian Lopresti
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Address
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Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
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Country
126294
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Australia
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Phone
126294
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+61 8 94487376
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Fax
126294
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Email
126294
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[email protected]
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Contact person for public queries
Name
126295
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Dr Adrian Lopresti
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Address
126295
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Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
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Country
126295
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Australia
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Phone
126295
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+61 8 94487376
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Fax
126295
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Email
126295
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[email protected]
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Contact person for scientific queries
Name
126296
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Dr Adrian Lopresti
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Address
126296
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Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
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Country
126296
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Australia
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Phone
126296
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+61 8 94487376
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Fax
126296
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Email
126296
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
for IPD meta-analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (
[email protected]
)
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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.
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