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临床试验/NCT01515098
NCT01515098已完成不适用

The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2012年1月1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
123
试验地点
1
主要终点
Change in cognitive test performance

研究概览

简要总结

Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans.

Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo.

Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo.

Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass).

Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers.

研究设计

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

入排标准

年龄范围
65 Years 至 79 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women age 65 and older
  • •BMI between 18.5 and 34.5
  • •Close individual to report memory decline

排除标准

  • •History of central nervous system or psychiatric disorders
  • •Dementia or Alzheimer's diagnosis
  • •Smoking >20 cigarettes/day
  • •Gastrointestinal/digestive disorders
  • •Uncontrolled chronic disease

研究组 & 干预措施

Blueberry Group

Experimental

37 grams of dehydrated blueberries daily for 6 months

干预措施: Freeze-dried blueberries (Dietary Supplement)

Placebo Group

Placebo Comparator

37 grams of dextrose powder daily for 6 months

干预措施: Dextrose Placebo (Dietary Supplement)

Reference Group

No Intervention

No intervention

结局指标

主要结局

Change in cognitive test performance

时间窗: Baseline, 180 days

Measured by CANTAB

Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)

时间窗: Baseline, 180 days

Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP)

次要结局

  • Change in body mass distribution(Baseline, 180 days)
  • Change in oxidative stress and inflammatory markers as measured in blood and urine(Baseline, 180 days)

研究者

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

Carol Cheatham, PhD

Assistant Professor of Psychology

University of North Carolina, Chapel Hill

研究点 (1)

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