The chronic effects of Bacopa and Pycnogenol on cognitive and cardiovascular function in a healthy older populatio

Not Applicable

Suspended

• Conditions: Mechanisms of natural supplements; Alternative and Complementary Medicine - Herbal remedies; Cardiovascular - Normal development and function of the cardiovascular system; Effects of natural supplements on brain function; Effects of natural supplements on gut microbiota; Effects of natural supplements on mood; Effects of natural supplements on inflammation and oxidative stress; Mental Health - Studies of normal psychology, cognitive function and behaviour; Effects of natural supplements on cognition; Effects of natural supplements on cardiovascular function

• Registration Number: ACTRN12611000487910
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-10
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speed of information processing via inspection<br>time on the Inspection Time Task and reaction time performance on the Hick Reaction Time Paradigm[at baseline, 3-month post-treatment commencement, 6-month post-treatment commencement and 12-month post-treatment commencement];Memory via performance on the following computerised tasks: Immediate and delayed word recall, delayed word recognition, immediate and delayed picture recognition, contextual memory, spatial working memory, numeric working memory[at baseline, 3-month post-treatment commencement, 6-month post-treatment commencement and 12-month post-treatment commencement];Sustained attention via the Rapid Visual Information Processing task[at baseline, 3-month post-treatment commencement, 6-month post-treatment commencement and 12-month post-treatment commencement]