Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cognitive Function Composite Score
研究概览
简要总结
Stroke is a strong risk factor for dementia, with up to 80% of individuals having lower cognitive function 5 years after a stroke event. However, having a stroke does not need to result in declining cognition if effective strategies to reduce the risk of post stroke dementia are identified. Diets containing nuts can reduce the risk of both dementia and stroke but have not been tested in stroke survivors. Therefore, this pilot study aims to determine whether eating nuts regularly reduces post-stroke cognitive decline and dementia. The NUT-me pilot study will supplement the diet of stroke survivors with a mix of nuts containing walnuts, hazelnuts, almonds and Brazil nuts for 3 months and assess the effects on cognition and health markers. The researchers predict that regular nut consumption will contribute to preserving post-stroke cognitive function in comparison to patients who do not consume nuts. The results of this novel pilot study will be used to guide a larger trial and provide a simple dietary strategy that stroke survivors can adopt to reduce post-stroke cognitive decline.
详细描述
This study will investigate the efficacy and feasibility of supplementing the habitual diet of stroke survivors with a supply of mixed nuts containing Brazil nut, walnuts, hazelnuts, and almonds to reduce post-stroke cognitive decline. The overall aim of this project will be achieved through the following objectives:
- Examine the feasibility through the assessment of compliance with the intervention and participants' perception of the study
- Investigate the efficacy of the intervention on cognitive decline, body composition and health outcomes (blood pressure, fasting glucose and insulin, and blood lipids) The investigators hypothesise that the inclusion of nuts is a simple dietary strategy that will slow post-stroke cognitive decline and that supplementation with nuts will improve body composition and health biomarkers of stroke survivors.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischaemic stroke (first or recurrent stroke) in the last 6 months
- •Able to attend 4 study visits over 3 months
- •Motivation and willingness to participate in the study protocol
- •No prior neurological or psychiatric disease, including dementia
- •Can give informed consent and participate in cognitive testing
排除标准
- •be < 18 years;
- •have allergy to nuts
- •have premorbid modified Rankin scale (mRS)≥4, denoting no severe disability
- •incapable of giving consent
- •have problems with mastication that preclude nut intake
- •have habitual consumption of tree nuts (>2 servings/wk) in the previous 2 months
- •have habitual consumption of alpha-linolenic acid supplements (fish oil, flaxseed oil, and/or soy lecithin)
- •have dementia or psychiatric disease
- •do not speak English
研究组 & 干预措施
Nut Group
Participants will receive a supply of mixed nuts containing: 1 Brazil nut (~3g), walnuts (15g), hazelnuts (7g), and almonds (7g) to be consumed daily for 90 days. They will also receive dietary counselling on how to follow the Australian Dietary Guidelines.
干预措施: Nuts (Other)
Control Group
Participants will follow the same protocol as the Nut group regarding appointments and collection of information. At the visits, they will receive dietary counselling on how to follow the Australian Dietary Guidelines
干预措施: Control (Other)
结局指标
主要结局
Cognitive Function Composite Score
时间窗: 90 days
Cognitive performance after the 90-day intervention will be assessed in comparison to baseline by using the NIH Toolbox Cognition Battery V3. This validated battery encompasses 15 tests that are combined to generate composite scores by age: Crystalised Composite (which includes picture vocabulary and oral reading recognition tests) and Fluid Composite (which includes dimensional change card sort, flanker, picture sequence memory, list sorting, and pattern comparison tests).The Cognitive Function Composite Score is a combination of both crystallized and fluid scores. Higher scores indicate better cognitive performance.
次要结局
- Crystallized Cognition Composite Score(90 days)
- % body fat(90 days)
- Depressive symptoms(90 days)
- HOMA-IR(90 days)
- Blood lipids(90 days)
- Inflammatory markers(90 days)
- Fluid Cognition Composite Score(90 days)
研究者
Barbara R. Cardoso
Senior Lecturer
Monash University