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

Plain Language Summary

Simplified for easier understanding

This study tests whether two different doses of Bacopa monnieri (a traditional herbal supplement used for memory and brain health) improve thinking and mental performance, and how they affect heart rate and stress levels. Participants will take each dose and a placebo on separate days, then complete a series of cognitive tests. You may be eligible if: - You are 18 to 56 years old - You are a non-smoker - You are generally healthy with no chronic illnesses - Your BMI is between 15.4 and 32.74 - You are not taking any medications, herbal supplements, or vitamins - You are not pregnant or breastfeeding You may NOT be eligible if: - You smoke - You have any neurological, heart, psychiatric, gut, or bleeding conditions - You take any regular medication, supplements, or vitamins - You are pregnant or breastfeeding Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.