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临床试验/NCT04643080
NCT04643080已完成不适用

Effects of a 12-week Dairy-based Probiotic Dietary Intervention on Cognitive Performance, Emotional Well-being, and Inflammation in Older Adults

University of Idaho4 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年3月7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
47
试验地点
4
主要终点
Change in Processing Speed from Baseline to 12-weeks

研究概览

简要总结

The purpose of this study was to determine the effect of dairy-based probiotics on cognitive function, emotional wellbeing, and inflammation. Subjects were assigned to either consume 6 oz of yogurt/day or abstain from consuming yogurt and other probiotic-containing foods for 12 weeks. Subjects completed baseline testing and 12-week follow-up testing consisting of a laboratory blood draw to assess inflammatory biomarkers, and a computerized assessment to evaluate cognitive and emotional wellbeing measures.

研究设计

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

入排标准

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

入选标准

  • •ability to participate in a 12-week study
  • •at least 50 years of age
  • •not currently taking a probiotic dietary supplement
  • •willing to refrain from consuming probiotic dietary supplements or fermented foods for 12-weeks
  • •willing to have blood drawn twice
  • •willing to consume yogurt daily for 12 weeks

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

Subjects were asked to avoid consuming fermented foods for 12 weeks.

Yogurt

Experimental

Subjects were asked to consume 6 oz. of yogurt daily for 12 weeks.

干预措施: Yogurt (Other)

结局指标

主要结局

Change in Processing Speed from Baseline to 12-weeks

时间窗: Change from baseline processing speed test scores at 12 weeks

Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Processing Speed was assessed by the Pattern Comparison Processing Speed test.

Change in Executive Function from Baseline to 12-weeks

时间窗: Change from baseline executive function test scores at 12 weeks

Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Executive function was assessed by the Flanker Inhibitory Control and Attention Test and the Dimensional Change Card Sort Test.

Change in Episodic Memory from Baseline to 12-weeks

时间窗: Change in baseline episodic memory score at 12 weeks

Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Episodic Memory was assessed by the Picture Sequence Memory test.

Change in Attention from Baseline to 12-weeks

时间窗: Change from baseline attention test scores at 12 weeks

Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Attention was assessed by the Flanker Inhibitory Control and Attention Test.

Change in Fluid Cognition Composite from Baseline to 12-weeks

时间窗: Change from baseline fluid cognition composite score at 12-weeks

Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. The fluid cognition composite score was derived from scores on the Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, Pattern Comparison Processing Speed Test, and List Sorting Working Memory test.

Change in Working Memory from Baseline to 12-weeks

时间窗: Change from baseline working memory test scores at 12 weeks

Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Working Memory was assessed by the List Sorting Working Memory test.

次要结局

  • Change in serum interleukin-6 concentration from baseline to 12 weeks(Change from baseline serum interleukin-6 concentration at 12 weeks)
  • Change in Social Satisfaction from Baseline to 12-weeks(Change from baseline social satisfaction test scores at 12 weeks)
  • Change in Psychological Wellbeing(Change from baseline psychological satisfaction test scores at 12 weeks)
  • Change in Negative Affect from Baseline to 12-weeks(Change from baseline negative affect test scores at 12 weeks)
  • Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks(Change from baseline serum tumor necrosis factor-alpha concentration at 12 weeks)
  • Change in serum c-reactive protein concentration from baseline to 12 weeks(Change from baseline serum c-reactive protein concentration at 12 weeks)

研究者

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

Annie Roe

Principal Investigator

University of Idaho

研究点 (4)

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