ACTRN12611000487910暂停未知
The chronic effects of Bacopa and Pycnogenol on cognitive and cardiovascular function in a healthy older population
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 75 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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