A Randomised Controlled Trial in 'At Risk' Humans Investigating the Cognitive Benefits of a Combined Flavonoid/Fatty Acid Intervention and Underlying Mechanisms of Action: The COGNITIVE AGING NUTRITION and NEUROGENESIS (CANN) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 6
- 主要终点
- Number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System
研究概览
简要总结
There is a dearth of research which takes a multi-compound approach to dietary interventions, in humans, aimed at improving outcome measures of cognition. Animal research in particular points towards fatty acids and flavonoids having a potentiating effect on each other, and possibly even being synergistic. Thus, study products will be administered in the present trial comprising both of these compounds, with a view to investigating their potential effects on cognition in older adults with mild cognitive impairment (MCI) or subjective memory impairment (SMI).
详细描述
240 participants, aged 55 or above, will be recruited (120 Norwich, 120 Melbourne; to include both MCI and SCI participants).
Participants will be asked to take the study food each day for 12 months, and to come to the clinical assessment unit on 3 occasions, at baseline, 3 months and 12 months, to complete a cognitive task battery such that their performance may be investigated in the context of the intervention.
Urine, blood and faecal samples will be collected and magnetic resonance imaging (MRI) will be applicable to half of each population (i.e to 60 MCI and 60 SCI, 30 of each at Norwich and Melbourne).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female, aged ≥ 55 years
- •Mild cognitive impairment (MCI) or subjective memory impairment (SMI) with no indication of clinical dementia or depression
- •Willing and able to provide written informed consent.
- •Understands and is willing and able to comply with all study procedures.
- •Fluent in written and spoken English.
- •In good general health including blood biochemical, haematological and urinalysis within the normal range at screening (as judged by the clinical advisor)
- •Normal, or corrected to normal vision and hearing
- •Right handed, for MRI
- •Stable use of any prescribed medication for at least four weeks
排除标准
- •Diagnosis of Alzheimer's disease (AD) or other form of dementia or significant neurological disorder
- •Parent or sibling who developed premature dementia <60y (suggestive of a familial monogenic form of cognitive decline)
- •Past history or MRI evidence of brain damage including significant trauma, stroke, learning difficulties or serious neurological disorder, including loss of consciousness > 24 hours
- •History of alcohol or drug dependency within the last 2 years
- •Other clinically diagnosed psychiatric disorder likely to affect the cognitive measures (as judged by clinical adviser)
- •Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids and fatty acids (as judged by clinical adviser)
- •Major cardiovascular event, e.g. myocardial infarction or stroke, in the last 12 months
- •Carotid stents or severe stenosis
- •Known allergy to fish or any other component in the intervention supplements
- •Existing medical conditions likely to affect the study measures (as judged by clinical adviser)
- •Uncontrolled hypertension (Systolic Blood Pressure (SBP) >140mmHg, Diastolic Blood Pressure (DBP) >90mmHg)
- •BMI >40kg/m2
结局指标
主要结局
Number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System
时间窗: 12 months
The CDR Computerized Cognitive Assessment System will be used to measure the cognitive effects of the treatments. The battery is sensitive to bidirectional cognitive change including trials in MCI, dementia and SMI. There is strong converging evidence that one particular aspect of performance, namely the number of false positive responses during a picture recognition task, is particularly sensitive to hippocampal integrity (based on activation of the dentate gyrus during the task, and specific decrements in conditions associated with poorer hippocampal function). This will form the primary outcome in this study.
次要结局
- Attention ability on the Digit Span task(12 months)
- Cerebrovascular blood flow(12 months)
- Measurement of blood brain barrier permeability(8 minutes)
- Executive function on the Trail Making Task(12 months)
- Hippocampal volume(12 months)
- Gut microflora speciation and metabolism(12 months)
- Circulating biomarkers of cognition(12 months)
- Visuospatial ability on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Figure Copy test(12 months)
- Association between baseline APOE status and number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System(12 months)
- Circulating biomarkers of cardiovascular health(12 months)
- Language ability on the Boston Naming Test(12 months)