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临床试验/ACTRN12620000270910
ACTRN12620000270910已完成未知

The effect of Complex Milk Lipids on cognitive function in older adults with Subjective Memory Complaints

Fonterra0 个研究点目标入组 236 人开始时间: 2020年3月2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
236

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
55 Years 至 76 Years(—)
性别
All

入选标准

  • 1. Males and females
  • 2. Aged >55 & <76 years of age at clinic screen
  • 3. Scores >25 on the subjective memory complaints questionnaire (MAC-Q)
  • 4. BMI >18.5 or <35 at time of clinic screen
  • 5. No Depression (indicated by scores <6 on the Geriatric Depression Scale (GDS-15)

排除标准

  • 1. Score of <22 on the MoCA
  • 2. Previous adverse reaction to milk or dairy proteins
  • 3. Allergy to rice
  • 4. Any condition/event* where cognitive impairment may occur as determined by the PI (e.g., head injury, other brain trauma, transient ischemic attacks, stroke, coronary artery bypass surgery, heart surgery, degenerative neurological disease)
  • 5. Previous diagnosis of Sleep Apnoea that remains untreated
  • 6. Blood pressure >155 mmHg and diastolic >95 mmHg (unless applicant obtains letter from medical professional indicating fit for inclusion)
  • 7. HbA1c >6.5% for non diabetics (=48mmol/mol), OR =7% (=53mmol/mol) if diagnosed with T2D and medically managed for at least 6-months
  • 8. Type 1 Diabetes
  • 9. Current smoker (or history of smoking including within last 12 months)
  • 10. History of Intellectual Disability or other neurodevelopmental disorder (e.g., language disorder, ADHD, Autism)*
  • 11. A mental health condition* that is being actively treated either pharmacologically or by a licensed mental-health professional
  • 12. Participation in a study utilising the primary cognitive measures within the previous 12 months
  • 13. Current or recent participation, within the last 30 days, in any other clinical trial involving the administration of an active intervention for any purpose.
  • * confirmed by trained Clinic Team Member; no clinical testing will be conducted to diagnose/confirm medical history

研究者

发起方
Fonterra

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