None listed
Conditions
Brief summary
This study aims to determine if Bacopa monnieri supplementation improves brain health, cognition and well-being in older adults undergoing regular cognitive training. 36 healthy adults aged 55 years or above, will be asked to complete 3 hours of cognitive training at home a week for 12 weeks, while consuming either 320mg of Bacopa monnieri extract or placebo per day. Participants are asked to attend three testing sessions at Swinburne University Hawthorn campus, which includes a screening and practice visit (approx. 2 hours) where consent is obtained, eligibility assessed and participants familiarised with study measures and procedures, and a baseline visit and final visit (3 hours each, 12 weeks apart) where study outcomes are assessed. Procedures measuring treatment efficacy include brain imaging using MRI, blood collection for bio-markers of inflammation and brain health, cognitive assessment of memory, reaction time and attention, and questionnaires assessing mood and everyday functioning.
Interventions
All participants will be asked to complete 3 1-hour sessions of computerised cognitive training in their home per week (BrainHQ exercises developed by Posit Science) for a 12-week period. The cognitive training battery includes 6 different tasks aimed to improve participants’ memory, reaction time and attention for aural and visually presented stimuli. Tasks include:
- making judgements about stimuli features
- discriminating between similar stimuli
- matching pairs of stimuli
- remembering th
All participants will be asked to complete 3 1-hour sessions of computerised cognitive training in their home per week (BrainHQ exercises developed by Posit Science) for a 12-week period. The cognitive training battery includes 6 different tasks aimed to improve participants’ memory, reaction time and attention for aural and visually presented stimuli. Tasks include: - making judgements about stimuli features - discriminating between similar stimuli - matching pairs of stimuli - remembering the order and sequences of presented stimuli - following instructions - reconstructing a narrative sequence Access to these tasks is through an online portal, which will allow researchers to monitor participant progress and compliance. In addition to the cognitive training, participants will also be randomly allocated to take one of two supplement treatments during the same 12 week period: - Bacopa monnieri (Flordis KeenMind 160mg, each capsule containing Bacopa monnieri equivalent to dry whole plant 2.16g) to take two capsules every morning with breakfast (total dosage per day 320mg). -2 placebo capsules containing an inert plant cellulose fibre To monitor treatment adherence, participants will be asked to complete a treatment taking log during the 12 weeks, in which they are required to tick off each time they take a capsule. In addition, they will be asked to return all left over treatments for a researcher to calculate compliance based on the amount of unused capsules.
Sponsors
Swinburne University of Technology, Centre for Human Psychopharmacology
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1) Male or female aged 55 years or above 2) Right handed 3) Has regular access to a computer with internet 4) Has corrected to normal vision 5) In good general health 6) Understands and is willing and able to comply with all study procedures
Exclusion criteria
1) Unable to understand or comply with testing procedures. 2) Evidence of clinical cognitive impairment as defined by a score of 23 or less in the Mini Mental State Examination (MMSE). 3) Evidence of clinical mood disturbance as defined by a score of 20 or more in the Beck Depression Inventory-II (BDI-II) 4) Is currently or within the last two years, has been diagnosed with a psychiatric disorder such as major depression, severe anxiety requiring treatment and/or schizophrenia. 5) Is currently diagnosed with a neurological disorder such as Alzheimer’s disease, Parkinson’s disease, stroke, epilepsy, brain tumours, or normal pressure hydrocephalus. 6) Has a history of repeated head injury. 7) Has experienced amnesia with or without loss of consciousness as a result of trauma to the head in the previous 14 days. 8) Has an active infection or sign/symptoms of an infection at V1. 9) Current diagnosis of a health condition which may affect food metabolism such as any inflammatory bowel diseases (e.g. , Crohn’s disease, ulcerative colitis), liver disease, allergies or kidney disease. 10) Has uncontrolled hypertension (systolic blood pressure more than140mmHg, diastolic blood pressure more than 90mmHg). 11) Currently taking supplements/ medication which has shown evidence to have cognitive altering effects and is unwilling to discontinue taking them four weeks prior and during the study period. 12) Female subjects currently pregnant or planning to conceive during the study period. 13) Currently participating in or has participated in another study involving an investigational product in the previous four weeks. 14) Has any implanted metal devices and electronically or magnetically activated devices. 15) Has claustrophobia. 16)Has had an MRI scan in the previous seven days before V1. 17) For blood test results only, significant hypotension before blood test at V1 (systolic blood pressure less than 90mmHg and diastolic blood pressure less than 60mmHg). 18) Currently taking illicit drugs or have a history of substance abuse 19) Currently consuming more than 14 standard alcoholic drinks per week. 20) Is a current smoker.
Outcome results
None listed