跳至主要内容
临床试验/ACTRN12621000038897
ACTRN12621000038897已完成未知

The effects of Lutein/Zeaxanthin supplementation on cognitive function in adults with self-reported mild cognitive complaints: a randomised, double-blind, placebo-controlled study

Clinical Research Australia0 个研究点目标入组 96 人开始时间: 2021年1月18日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
96

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 75 Years(—)
性别
All

入选标准

  • 1. Healthy adults (male and female) between 40 and 75 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 35 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, acute or chronic pain condition
  • 4. 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
  • 5. History of 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. Current nutrient deficiencies including low iron or vitamin B12 concentrations
  • 9. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
  • 10. Current or 12-month history of illicit drug abuse
  • 11. Alcohol intake greater than 14 standard drinks per week
  • 12. Any significant surgeries over the last year

研究者

发起方
Clinical Research Australia

相似试验