ANZCTR - Registration

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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

Cardiovascular function in healthy older individuals

Stress

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Cardiovascular

Normal development and function of the cardiovascular system

Mental Health

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]

Behaviour

Intervention code [2]

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]

Cognitive Function using Cognitive Drug Research (CDR) battery, Swinburne University Computerised Cognitive aging Battery (SUCCAB) battery

Timepoint [1]

Baseline and 2 hours post dose

Primary outcome [2]

Cardiovascular function using transcranial doppler ultrasound and arterial stiffness measure (using sphygmocor system)

Timepoint [2]

Baseline and 2 hrs post dose

Secondary outcome [1]

Stress/mood using multitasking battery to induce stress and mood questionnaires before and after stress task

Timepoint [1]

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

Sex

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

1/08/2009

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]

University

Name [1]

Swinburne University

Address [1]

400 Burwood Rd
Hawthorn VIC 3122

Country [1]

Australia

Primary sponsor type

University

Name

Swinburne University

Address

400 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne University Human Research Ethics Committee

Ethics committee address [1]

PO Box 218
Hawthorn VIC 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Marni Kras

Address

400 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Phone

613 9214 5094

Fax

[email protected]

Contact person for scientific queries

Name

Con Stough

Address

400 Burwood Rd
Hawthorn VIC 3122

Country

Australia

Phone

613 9214 8167

Fax

[email protected]

No information has been provided regarding IPD availability

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.

Trial Review

Documents added manually

Documents added automatically