ACTRN12624000351516招募中Unknown
An examination into the effects of tocotrienols (TheraPrimE rice) on cognitive abilities in healthy adults: a randomised, double-blind, placebo-controlled trial
Clinical Research Australia0 个研究点目标入组 90 人开始时间: 2024年3月27日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Healthy individuals (male and female) aged between 40 to 80 years
- •2. Residing in independent living accommodation
- •3. Subjective report of memory or attention problems by answering ‘yes’ to the following question: Do you have problems with your memory, attention, or concentration?
- •4. Non-smoker
- •5. BMI between 18 and 30 kg/m2
- •6. No plan to commence new treatments over the study period
- •7. Understand, willing and able to comply with all study procedures
- •8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
排除标准
- •1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria
- •2. A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
- •3. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, cancer/ malignancy, acute or chronic pain condition
- •4. Diagnosis of neurological or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy
- •5. History of paralysis, stroke or seizures or head injury (with loss of consciousness).
- •6. Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, or steroid medications.
- •7. Change in medication in the last 3 months or expectation to change during the study duration
- •8. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
- •9. Alcohol intake greater than 14 standard drinks per week
- •10. Current or 12-month history of illicit drug abuse
- •11. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant.
- •12. Any significant surgeries over the last year
- •13. Planned major lifestyle change in the next 3 months
研究者
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