RecruitingPhase 3Phase 4ACTRN12609000717257

Can an acute dosage of Bacopa Monniera (brahmi) improve cognition, cardiovascular function and stress in a healthy older population

Acute cognitive, cardiovascular and stress effects of Bacopa Monniera on healthy older human participants.


Sponsor

Swinburne University

Enrollment

32 participants

Start Date

Aug 1, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a single dose of Bacopa monniera (also known as brahmi, an Ayurvedic herbal supplement) can improve memory, thinking, cardiovascular function, and the body's response to stress in healthy older adults. Bacopa has been used in traditional medicine for thousands of years and recent research suggests it may improve memory and reduce anxiety. This study gives participants either a Bacopa tablet or a placebo on two separate occasions, and tests their thinking ability, heart function, and stress response before and after taking the tablet, to see if a single dose has any immediate effect. You may be eligible if: - You are between 50 and 65 years old - You are free of psychiatric and neurological conditions - You have no history of chronic illness or infection - You have normal or corrected-to-normal vision - You are a non-smoker - You are not taking antidepressants, antipsychotics, anticoagulants, or other brain-active medications You may NOT be eligible if: - You smoke - You have a psychiatric or neurological condition - You have an endocrine, gastrointestinal, or bleeding disorder - You are pregnant or breastfeeding - You take anticoagulants, antidepressants, antipsychotics, or similar medications - Your vision is not corrected to normal Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

Australia

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ACTRN12609000717257


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