None listed
Conditions
Brief summary
The primary objective of the current study is to replicate a recent study conducted in our centre (Benson et al., 2013) in order to confirm these results and to provide further data on the acute cognitive effects of an extract of Bacopa (KeenMind). The secondary objective of the study is to extend upon the study by Benson et al. (2013) by examining a wider range of doses to ascertain whether there is a dose-response relationship between KeenMind and cognition. The study will be an acute, 4-arm, randomised, double-blind, placebo-controlled crossover design. Participants will attend 4 testing sessions (and 1 practice session) where they will complete cognitive, mood and stress assessments, prior to and 1, 2 and 4 hours post supplementation. The participant group will be healthy adults aged between 18-55yrs, who are able to commit to five visits to Swinburne University to attend testing sessions. Participants will not be taking any supplements or medications and have no current medical or psychiatric diagnosis. Participants will orally consume each treatment one occasion, directly after a light meal. Each treatment will be administered after a 1 week wash out period. Treatment 1 – Placebo Treatment 2 – 320mg KeenMind Treatment 3 – 640mg KeenMind Treatment 4 – 960mg KeenMind
Interventions
On each testing day, participants consume six identical capsules containing either an inert placebo, 320mg of KeenMind (Registered Trademark) (CDRI 08) Bacopa Monnieri (BM) extract or 640mg of KeenMind (Registered Trademark) (CDRI 08) BM extract or 960mg of KeenMind (Registered Trademark) (CDRI08) BM extract. The Bacopa treatment used will be standardized. Bacosides A and B must be present and account for at least 55% of the product. Each capsule contains 160 mg BM extract.
Each participant is
On each testing day, participants consume six identical capsules containing either an inert placebo, 320mg of KeenMind (Registered Trademark) (CDRI 08) Bacopa Monnieri (BM) extract or 640mg of KeenMind (Registered Trademark) (CDRI 08) BM extract or 960mg of KeenMind (Registered Trademark) (CDRI08) BM extract. The Bacopa treatment used will be standardized. Bacosides A and B must be present and account for at least 55% of the product. Each capsule contains 160 mg BM extract. Each participant is required to attend a total of 5 sessions (1 practice visit and 4 study visits) that will be conducted one week apart to ensure sufficient washout between each acute condition. Total amount of testing days is 5 weeks (inclusive of practice visit). There will be four separate testing days where either the placebo, 320 mg of KeenMind (Registered Trademark) or 640 mg of KeenMind (Registered Trademark) or 960 mg of KeenMind (Registered Trademark) will be taken exclusively each day.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
- Non-smoker - Age between 18 and 55 years - Healthy (absence of all exclusion criteria) male and female adults - Not taking any medication, herbal extracts, 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
Exclusion criteria
- Smoker - Heavy regular use of alcohol (more than 14 standard drinks per week) - 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, dietary supplements (which may influence cognitive or mood) or illicit drugs - Pregnant or lactating
Outcome results
None listed