Clinical trial NCT04643080: Dairy Based Probiotic Intervention and Cognitive, Emotional, and Inflammatory Outcomes
Official title: Effects of a 12-week Dairy-based Probiotic Dietary Intervention on Cognitive Performance, Emotional Well-being, and Inflammation in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Cognitive Change
Inflammation
Emotions
Keywords: Probiotics
Cognition
Emotional Wellbeing
Inflammation
Older Adults
Yogurt
Lead sponsor: University of Idaho
Sponsor class: OTHER
Collaborators: name: Kansas State University
First posted: 2020-11-24
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Fluid Cognition Composite from Baseline to 12-weeks
timeFrame: Change from baseline fluid cognition composite score at 12-weeks
measure: Change in Executive Function from Baseline to 12-weeks
timeFrame: Change from baseline executive function test scores at 12 weeks
measure: Change in Attention from Baseline to 12-weeks
timeFrame: Change from baseline attention test scores at 12 weeks
measure: Change in Working Memory from Baseline to 12-weeks
timeFrame: Change from baseline working memory test scores at 12 weeks
measure: Change in Processing Speed from Baseline to 12-weeks
timeFrame: Change from baseline processing speed test scores at 12 weeks
measure: Change in Episodic Memory from Baseline to 12-weeks
timeFrame: Change in baseline episodic memory score at 12 weeks
Secondary outcomes:
measure: Change in Negative Affect from Baseline to 12-weeks
timeFrame: Change from baseline negative affect test scores at 12 weeks
measure: Change in Psychological Wellbeing
timeFrame: Change from baseline psychological satisfaction test scores at 12 weeks
measure: Change in Social Satisfaction from Baseline to 12-weeks
timeFrame: Change from baseline social satisfaction test scores at 12 weeks
measure: Change in serum interleukin-6 concentration from baseline to 12 weeks
timeFrame: Change from baseline serum interleukin-6 concentration at 12 weeks
measure: Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks
timeFrame: Change from baseline serum tumor necrosis factor-alpha concentration at 12 weeks
measure: Change in serum c-reactive protein concentration from baseline to 12 weeks
timeFrame: Change from baseline serum c-reactive protein concentration at 12 weeks
Other outcomes:
Locations:
city: Boise
country: United States
facility: University of Idaho
state: Idaho
city: Coeur d'Alene
country: United States
facility: University of Idaho
state: Idaho
city: Pocatello
country: United States
facility: University of Idaho
state: Idaho
city: Manhattan
country: United States
facility: Kansas State University
state: Kansas
Study officials:
References: