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Trial registered on ANZCTR


Registration number
ACTRN12609000717257
Ethics application status
Approved
Date submitted
18/08/2009
Date registered
21/08/2009
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can an acute dosage of Bacopa Monniera (brahmi) improve cognition, cardiovascular function and stress in a healthy older population
Scientific title
Acute cognitive, cardiovascular and stress effects of Bacopa Monniera on healthy older human participants.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function in healthy older individuals 237371 0
Cardiovascular function in healthy older individuals 237372 0
Stress 243534 0
Condition category
Condition code
Alternative and Complementary Medicine 239693 239693 0 0
Herbal remedies
Cardiovascular 239695 239695 0 0
Normal development and function of the cardiovascular system
Mental Health 239834 239834 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 X 150mg capsules Bacopa Monniera

Participants consume oral capsules after baseline testing on one day only (to test the acute effects)

Intervention and Placebo are administered in a randomised order with 1 week between treatments.
Intervention code [1] 237021 0
Behaviour
Intervention code [2] 241143 0
Prevention
Comparator / control treatment
2 X 150mg Avicel microcrystalline cellulose Participants consume 2 X150mg oral capsules after baseline testing on one day only. Intervention and Placebo are administered in a randomised order with 1 week between treatments.
Control group
Placebo

Outcomes
Primary outcome [1] 240464 0
Cognitive Function using Cognitive Drug Research (CDR) battery, Swinburne University Computerised Cognitive aging Battery (SUCCAB) battery
Timepoint [1] 240464 0
Baseline and 2 hours post dose
Primary outcome [2] 240465 0
Cardiovascular function using transcranial doppler ultrasound and arterial stiffness measure (using sphygmocor system)
Timepoint [2] 240465 0
Baseline and 2 hrs post dose
Secondary outcome [1] 244997 0
Stress/mood using multitasking battery to induce stress and mood questionnaires before and after stress task
Timepoint [1] 244997 0
Baseline and 2 hrs post dose

Eligibility
Key inclusion criteria
- Free from psychiatric disorders
- No neurological diseases
- Not suffering from endocrine, gastrointestinal or bleeding disorders
- No history of chronic illness/infection
- Not currently pregnant or lactating
- Must not be taking anticoagulants, antidepressants, antipsychotics, anxiolytics, acetylcholine esterase (AChE) inhibitors, anti-Parkinson’s medication, illicit drugs or any cognitive enhancing drugs
- Must have corrected to normal vision
- Non smoker
Minimum age
50 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Smokers
- Psychiatric disorder
- Neurological diseases
- Suffering from endocrine, gastrointestinal or bleeding disorders
- A history of chronic illness/infection
- Pregnant or lactating
- Taking anticoagulants, antidepressants, antipsychotics, anxiolytics, AChE inhibitors, anti-Parkinson’s medication, illicit drugs or any cognitive enhancing drugs
- Vision that is not normal or corrected to normal

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)
Participants will be recruited through advertising and word of mouth. After successfully completing the phone screen, medical screen and practice session, they will be randomly allocated to receive either treatment A or B on their first testing day. This will be done by a randomised computer number sequence generator. On their second testing day, they will receive the other treatment. A disinterested third party will be responsible for the blinding procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party will generate the randomisation sequence using a computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)

Funding & Sponsors
Funding source category [1] 237406 0
University
Name [1] 237406 0
Swinburne University
Address [1] 237406 0
400 Burwood Rd
Hawthorn VIC 3122
Country [1] 237406 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
400 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 236903 0
None
Name [1] 236903 0
Address [1] 236903 0
Country [1] 236903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239538 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 239538 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 239538 0
Australia
Date submitted for ethics approval [1] 239538 0
Approval date [1] 239538 0
Ethics approval number [1] 239538 0
SUHREC 2009/136

Summary
Brief summary
Bacopa Monnieri (BM) was first defined as a phytochemical brain tonic and touted to have the ability to improve memory, learning, and concentration for 3000 years (Zhou et al., 2007). Bacopa of late has had the statistical backing to support its cognitive enhancing capabilities (Calabrese et al., 2008) and since these findings BM has been trialled in a number of different settings offering new insights to its cognitive and physiological benefits. Investigations using BM on the response of elderly subjects uncovered significant cognitive improvements and a complete tolerability of the herb over a 12-week study (Calabrese et al. 2008). Elderly participants significantly improved their performance on learning tests and stroop tasks and showed decreases in Center for Epidemiologic Studies Short Depression Scale (CESD-10) depression scores and State-Trait Anxiety Indicator scores (STAI) scores. These studies allow us to hypothesize that cognitive improvements with the use of BM made after the age of 65 indicate its possible effectiveness on age related disorder (Calabrese et al. 2008; Barbhaiya et al.'s 2008). No study has reported any adverse events that weren’t also experienced by placebo groups, indicating a high tolerability of the drug among healthy human subjects.

Furthermore using animal models, BM has been implicated in the amelioration of vascular dysfunction (Dar and Channa 1997), the decreased accumulation of beta-amyloid-42 (Holcomb et al. 2006) and acetylcholinesterase (Das et al. 2002), decreased levels of cholesterol (Anbarasi et al., 2005), and increased the activity of free radicals (Bhattacharya et al. 2000; Dhanasekaran et al. 2007) lessening the impact of oxidative stress associated with ageing and Alzheimer’s Dementia.

The study will be an acute double blind, placebo controlled, crossover design investigating stress levels, cardiovascular effects, aortic elasticity, and cognitive function in an older adult population. Participants are required to attend testing sessions on three occasions; one practice day and two subsequent testing days separated by a seven day washout period. On the first of the testing days the participants will be randomly assigned to either placebo or treatment group and will then crossover groups on the second testing day. Each testing day will consist of a battery of tests, followed by the administration of the drug and a two hour wait period, followed by a second round of battery testing. The results of both pre-treatment and post-treatment testing will be compared using a repeated measures analysis of variance contrasting both groups in each condition over several testing periods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29972 0
Address 29972 0
Country 29972 0
Phone 29972 0
Fax 29972 0
Email 29972 0
Contact person for public queries
Name 13219 0
Marni Kras
Address 13219 0
400 Burwood Rd
Hawthorn VIC 3122
Country 13219 0
Australia
Phone 13219 0
613 9214 5094
Fax 13219 0
Email 13219 0
nutra@swin.edu.au
Contact person for scientific queries
Name 4147 0
Con Stough
Address 4147 0
400 Burwood Rd
Hawthorn VIC 3122
Country 4147 0
Australia
Phone 4147 0
613 9214 8167
Fax 4147 0
Email 4147 0
cstough@swin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results