Examining the Therapeutic Effects of Bacopa monnieri Supplementation and Cognitive Training on Brain Health, Cognition and Everyday Function in Healthy Older Adults.
- Conditions
- cognitive functionbrain functionbrain healthmoodAlternative and Complementary Medicine - Other alternative and complementary medicineMental Health - Studies of normal psychology, cognitive function and behaviourNeurological - Studies of the normal brain and nervous system
- Registration Number
- ACTRN12617001101370
- Lead Sponsor
- Swinburne University of Technology, Centre for Human Psychopharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method