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临床试验/NCT03419052
NCT03419052已完成不适用

MIND Food and Speed of Processing Training in Older Adults With Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial

Indiana University2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2019年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
212
试验地点
2
主要终点
Executive Cognitive Function Composite Score

研究概览

简要总结

The purpose of this study is to learn how foods high in polyphenols and brain training exercises affect older adults' cognitive performance

详细描述

Adults with low education who give informed consent will complete a baseline cognitive assessment and then be randomized to one of four arms: 1) MIND foods and cognitive training, 2) MIND foods and control training, 3) control foods and cognitive training, or 4) control foods and control training.

All interventions are conducted through applications running on a tablet computer device that we will provide to all participants for the study duration. Cognitive training is delivered through the online BrainHQ program from Posit Science, Inc. The foods will be shown on the tablet device in an online shopping format. Selected foods will be prepared and delivered by the study team.

Active intervention will last for 12 weeks. After the 12-weeks, free food deliveries will cease but participants who were allocated to cognitive training will continue to have access to BrainHQ. Those in the MIND food arms will be encouraged to maintain MIND food consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

MINDSpeed Intervention

Experimental

Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training

干预措施: MIND foods (Behavioral)

Control foods and speed of processing training

Active Comparator

Consumption of low polyphenol foods AND speed of processing training

干预措施: Control foods (Behavioral)

Double Control

Sham Comparator

Consumption of low polyphenol foods AND online (inert) games

干预措施: Cognitive training control (Behavioral)

MINDSpeed Intervention

Experimental

Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training

干预措施: Speed of processing training (Behavioral)

MIND food and training control

Active Comparator

Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games

干预措施: MIND foods (Behavioral)

MIND food and training control

Active Comparator

Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games

干预措施: Cognitive training control (Behavioral)

Control foods and speed of processing training

Active Comparator

Consumption of low polyphenol foods AND speed of processing training

干预措施: Speed of processing training (Behavioral)

Double Control

Sham Comparator

Consumption of low polyphenol foods AND online (inert) games

干预措施: Control foods (Behavioral)

结局指标

主要结局

Executive Cognitive Function Composite Score

时间窗: Immediately following the 12-week intervention (Immediate Post-Training)]

Executive Cognitive Function Composite Score as Measured by Individually-Administered Tests of Verbal Fluency, Complex Sequencing, Response Inhibition, and List Learning. The scale score range is -20 to 20. Low scores represent worse function and higher scores represent better function.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Clark

Associate Professor of Medicine

Indiana University

研究点 (2)

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