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临床试验/NCT03727386
NCT03727386已完成不适用

A Study Evaluating the Feasibility of Undertaking an Intervention Looking Into the Effect of Vegetable Oils Intake on Cognition and Quality of Life in Adults With Mild Cognitive Impairment.

Bournemouth University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Vegetable oil usage

研究概览

简要总结

This study explores the feasibility of applying an intervention using vegetable oils (coconut and sunflower oils) on individuals diagnosed with Mild Cognitive Impairment. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months.

详细描述

Research has shown that some forms of dementia associated to ageing can often be linked to low levels of sugar in the brain. Which may cause damage to the brain nerve cells. The main source of fuel for the brain comes from sugar in the form of glucose. Providing an additional source of fuel to brain cells may reduce the damage, potentially preventing further decline of dementia in individuals with Mild Cognitive Impairment (MCI).

This study explores the possibility of using vegetable oils (coconut and sunflower oils) as an additional source of energy to individuals diagnosed with Mild Cognitive Impairment. The researchers will use different tests to evaluate if the study could be done. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months. The researchers will visit participants in their houses over three times during the study to collect the data.

During each visit, the researcher will conduct blood test in which blood will be collected by pricking the finger of participants to check their blood ketone levels. Paper pencil and/or computer tasks will be completed to measure the cognitive abilities (e.g. attention, orientation and learning) of participants. Participants will also be asked to complete a food diary in which they will provide details of their diet and eating habits. Moreover, they will be asked to provide feedback on the study by answering a set of questions either during an interview or by completing a feedback form. The information collected during these visits will be used to evaluate the study.

Results from this study would help determine whether such an intervention can be undertaken in adults with MCI. The study will provide information related to the practicality of using vegetable oils on adults with MCI. This would provide the evidence to develop a larger study that would allow us to systematically evaluate the effect of vegetable oils on MCI. Which would further enable us to develop an intervention that might possibly improve the brain functions of adults with MCI and maintain their quality of life for longer by delaying the development of dementia and reducing the progression from MCI to AD (Alzheimer's disease) in adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with confirmed MCI diagnosis
  • Adults with Negative Apo E4 genotype

排除标准

  • Adults diagnosed with Alzheimer's Disease (AD)
  • Adults with positive Apo E4 genotype
  • Adults with confirmed diabetes (Type I, Type II) diagnosis
  • Adults with a history of hyper-cholesterolemia (high cholesterol levels) or Dyslipidaemia
  • Adults who are unable to understand written or verbal English
  • Adults diagnosed with Neurological disorders (Parkinson, stroke...)
  • Adults with post traumatic brain injury (tumour, brain surgery, injury...)
  • Patients with major physical impairments (blind, deaf) or those who are unable to use their dominant hand.
  • Adults with coconut allergy.

结局指标

主要结局

Vegetable oil usage

时间窗: 6 months

the amount of oil used by individuals (ml) will be monitored

次要结局

  • Overall cognition(Six months)
  • Verbal Memory(six months)
  • Dietary intake assessed by four day food records using Nutritics software(six months)
  • Blood samples (beta hydroxyl butyrate):(six months)
  • Executive measure(six months)
  • Quality of life of adults with Mild cognitive impairment measured by ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study Mild Cognitive Impairment- Activities of Daily Living)(six months)
  • Attention(six months)
  • Verbal Fluency(six months)
  • Processing Speed(six months)
  • Visual Spatial memory(six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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