ACTRN12621000496819进行中（未招募）未知
Effects of a polyphenol-rich grape and blueberry extract on cognitive function in older adults with mild cognitive impairment
Clinical Research Australia0 个研究点目标入组 143 人开始时间: 2021年4月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 143
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
- 60 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Healthy adults (male and female) 60 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. A score of between 13 and 18 on the telephone administered Montreal Cognitive Assessment – Blind Version (MoCA-BV)
- •5. Non-smoker
- •6. BMI between 18 and 30 kg/m2
- •7. No plan to commence new treatments over the study period
- •8. Understand, willing and able to comply with all study procedures
- •9. 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. Suffering from recently diagnosed (within 3 months), 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, acute or chronic pain condition
- •3. Diagnosis of medical 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
- •4. A score greater than 5 on the Geriatric Depression Scale, Short Form (GDS-SF) and/or a score greater than 7 on the Patient Health Questionnaire – 4 (PHQ-4)
- •5. History of stroke or seizures or head injury (with loss of consciousness).
- •6. Regular medication intake including but not limited to anticoagulants, blood thinners and anti-hypertensive drugs, anticholinergics, acetylcholinesterase inhibitors, or steroid medications.
- •7. Change in medication in the last 3 months or expectation to change during the study duration
- •8. Reported nutrient deficiencies including low iron or vitamin B12
- •9. Taking vitamins, herbal, or omega-3 supplements that are reasonably expected to influence study measures.
- •10. People with fragile veins and past difficulty in giving blood.
- •11. Current or 12-month history of illicit drug abuse
- •12. Alcohol intake greater than 14 standard drinks per week
- •13. Any significant surgeries over the last year
- •14. Planned major lifestyle change in the next 6 months
研究者
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