RecruitingPhase 3Phase 4ACTRN12612000810819

Cognitive demand and acute Bacopa monnieri (CDRI08) supplementation

The effects of sustained mental effort upon cardiovascular functioning and stress reactivity in healthy adults: an acute, double-blind, placebo controlled crossover study of 320mg and 640mg doses of a special extract of Bacopa monnieri (CDRI08).

Sponsor

Swinburne University

Enrollment

50 participants

Start Date

Jul 31, 2012

Study Type

Interventional

Conditions

Cardiovascular measures (blood pressure, arterial stiffness and cerebral blood flow)Cognitive Function

Summary

This research project is aiming to determine the effects of Bacopa on cognitive function, cardiovascular function and stress. Bacopa is a herb found in wetlands and muddy shore lines that has been used in traditional Indian medicine as a treatment for epilepsy and asthma. Russo & Borrelli (2005) claim that it has been used for over 3000 years as a memory and intellect enhancer. There is also evidence to suggest that Bacopa is an antioxidant, playing an important role in reducing the oxidation of fats in the bloodstream. This study will investigate the cognitive, cardiovascular and stress effects of a two doses of bacopa compared to placebo. Participants will be required to consume one of three treatments on each testing day, and will consume the other treatments on the other two days of testing. After the first battery of tests, each participant will be administered their treatment and have a two hour wait period. At the end of this period the participant will complete the second series of battery tests. There will be a seven day washout period and the process will be repeated again. (1) Bacopa – 320mg (2) Bacopa – 640mg (3) Placebo

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 56 Yearss

Inclusion Criteria2

Non-smoker
Age between 18 and 56 years

Exclusion Criteria11

BMI between 15.40 to 32.74 kg/m2
Not taking any medication, herbal extracts, vitamin supplements or illicit drugs
Not pregnant or lactating
Participants must abstain from caffeine-containing foods/beverages and alcohol for 24 hours prior to the training session and each testing session.
Written informed consent obtained
Smoker
Existing or pre-existing physical or neurological conditions
History of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
Existing chronic illness and infection
Taking any medication, herbal extracts, vitamin supplements or illicit drugs
Pregnant or lactating

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Interventions

On each testing day, participants consume four capsules containing an inert placebo, 320mg of KeenMind(Registered Trademark) (CDRI 08) BM extract or 640mg of KeenMind (Registered Trademark) (CDRI 08)

On each testing day, participants consume four capsules containing an inert placebo, 320mg of KeenMind(Registered Trademark) (CDRI 08) BM extract or 640mg of KeenMind (Registered Trademark) (CDRI 08) BM extract. KeenMind (Registered Trademark) (CDRI 08) is standardized for no less than 55% of total bacosides. Each capsule contains 160 mg BM extract (25:1) equivalent to 4 g of dried herb. Each participant is required to attend a total of 4 sessions (1 practice visit and 3 study visits) that will be conducted one week apart to ensure sufficient washout between each acute condition. Total amount of testing days is 4 weeks (inclusive of practice visit). There will be three separate testing days where either the placebo, 320 mg of KeenMind (Registered Trademark) or 640 mg of KeenMind (Registered Trademark) will be taken exclusively each day.