Cognitive demand and acute Bacopa monnieri (CDRI08) supplementation

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: 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. CONDITION: Cardiovascular measures (blood pressure, arterial stiffness and cerebral blood flow) Cognitive Function PRIMARY OUTCOME: Cognitive Improvement: ; ‐ Rapid visual information processing task (accuracy) ‐ measure of sustained attention, reaction time and false alarm rate ; ‐ Serial sevens ‐ measure of concentration and working memory ; ‐ Serial Threes ‐ measure of concentration and working memory SECONDARY OUTCOME: 'Stress and mental fatigue' Visual Analogue Scale (VAS) Cardiovascular measures ; ‐ blood pressure ; ‐ arterial stiffness ; ‐ cerebral blood flow ; ; Brachial blood pressure is calculated in the morning with the participant seated and following a 5 min rest period. All measurements are calculated using an automatic sphygmomanometer, designed for professional use (Omron, 705IT) and validated according to both the European ; Hypertension Society (EHS) and the British Hypertension Society (BHS) protocols. Measurements are completed using an appropriately sized cuff by an experienced research assistant and a cardiac technologist. The mean arterial pressure (MAP) is calculated according to the following formula (2 x DBP + SBP)/3. Pulse pressure and augmentation index PP and augmentation index are calculated centrally using a non‐invasive device (SphygmoCor; AtCor Medical, Sydney, Australia) by means of applanation tonometry. Through a mathematical transfer function, SphygmoCor derived the ascending aortic waveform from a recording of the radial artery before automatically calculating a range of cardiovascular parameters indicative of arterial stiffness. PP is automatically calculated by deducting the central diastolic pressure from the central systolic pressure whereas central augmentation index is calculated by dividing the augmentation pressure by the PP, multiplied by 100. All recordings are to be completed with the participant sitting down whilst their arm rested on a table with their palm facing upwards. INCLUSION CRITERIA: ‐ Non‐smoker ‐ Age between 18 and 56 years ‐ Healthy (absence of all exclusion criteria) male and female adults ‐ 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
Epistemonikos ID: ec047fbd3662adb1dd5c9bee764e5421ae11339d
First added on: Aug 25, 2024