None listed
Conditions
Brief summary
This study will investigate the effects of chronic administration of two natural supplements on cognition, cardiovascular function and biological measures, in comparison to a placebo. The primary aim of this project is to determine whether 12 months administration of the natural supplements Bacopa monniera (EBm) and Pycnogenol (PYC) improve cognitive functioning in a healthy older population. The secondary aims of this project are to investigate the mechanisms underpinning any cognitive effects of EBm and PYC by examining the relationship between cognition, biochemical, neuroimaging and cardiovascular measures and to investigate the time course of any improvements. The study will follow a double-blind, randomised, placebo-controlled, between-group design. Participants will be required to consume one of three types of supplements (EBm, PYC, or placebo) daily for 12-months. We will measure performance on different cognitive tasks, mood, brain imaging (for a sub-group of participants), gut microbiota (for a sub-group of participants), cardiovascular and biochemical measures before treatment (baseline), 3-months, 6-months and 12-months after consuming the treatment. In addition, as a sub-study to the main project 150 participants will be recruited to take part only in baseline assessments. The participants will undergo the same measures (excluding brain imaging) as for the main study, but will not receive any intervention and will not be required to attend follow-up assessments. This sub-study will allow further exploration of the relationship between GI microbiota and the other outcome measures including cognition, mood and cardiovascular function.
Interventions
Participants will consume a nutraceutical treatment daily for 12 months. Participants will be randomly allocated to one of three natural supplements (each of which is taken as oral capsules): Bacopa Monniera (300mg/day), Pycnogenol (150mg/day), and a placebo.
In addition, a sub-group of 150 participants will be recruited and will complete baseline assessments only but will not receive any intervention. The data collected from these participants will be used to further explore the relationship b
Participants will consume a nutraceutical treatment daily for 12 months. Participants will be randomly allocated to one of three natural supplements (each of which is taken as oral capsules): Bacopa Monniera (300mg/day), Pycnogenol (150mg/day), and a placebo. In addition, a sub-group of 150 participants will be recruited and will complete baseline assessments only but will not receive any intervention. The data collected from these participants will be used to further explore the relationship between gut microbiota and cognitive function, and will form the basis of a PhD student's thesis.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Participants who meet the following inclusion criteria will be included in the trial; 1.) Healthy non-smoking males and females aged 60 - 75 years 2.) Free from psychiatric disorders 3.) No neurological diseases 4.) Not suffering from severe cardiovascular, gastrointestinal or endocrine disorders 5.) Not suffering from any other disorders affecting food metabolism 6.) No recent history (past 5 years) of chronic/severe illness (longer than 6 weeks) 7.) Must not be taking antidepressants, antipsychotics, anxiolytics, AChE inhibitors, illicit drugs or significant cognitive enhancing drugs that will interfere with the study measures (e.g. chronic intake of substances such as Ginkgo) 8.) Must score 24 and above on the Mini-Mental Status Examination (MMSE) 9.) Must score <20 on the Geriatric Depression Scale 10.) Must have corrected to normal vision 11.) No alcohol abuse (defined as greater than 14 standard drinks per week for women and 28 standard drinks per week for men) or addiction. 12.) No concurrent participation in any other clinical trial For a sub-set of participants who will complete the MRS imaging, participants must also meet the following criteria in addition to the criteria above: 13.) Right handed 14.) Must not have any metal on or in your body such as that from any surgery involving metal plates and pace makers which increases the risk of having a Magnetic Resonance Imaging scan 15) Must not have non-removable body piercings 16) Must not have worked as a welder or have metal splinters in your body
Exclusion criteria
Participants who report any of the following will be excluded from the trial; 1.) Smokers 2.) Psychiatric disorder 3.) Neurological disease 4.) Significant endocrine, gastrointestinal or cardiovascular disorder 5.) Other disorders effecting food metabolism 6.) Recent history (past 5 years) of chronic/severe illness (longer than 6 weeks) 7.) Taking psychoactive medication including, antidepressants, antipsychotics, anxiolytics, AChE inhibitors, illicit drugs or significant cognitive enhancing drugs (e.g. chronic intake of substances such as Ginkgo) 8.) A score <24 on the MMSE 9.) A score >19 on the Geriatric Depression Scale 10.) Vision that is not corrected to normal 11.) Current regular alcohol use exceeding 14 standard drinks per week for women and 28 standard drinks per week for men 12.) Clinical trial participation additional to ARCLI MRI Component Participants who report any of the following will be excluded from the trial: 1.) Left handed 2.) Pacemaker 3.) Infusion pumps 4.) Aneurysm clips 5.) Metal protheses 6.) Metal joints 7.) Metal rods 8.) Metal plates 9.) Metal staples 10.) Non-removable body piercings 11.) Persons who have worked as welders or may have metal splinters in their body
Outcome results
None listed