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Dairy Based Probiotic Intervention and Cognitive, Emotional, and Inflammatory Outcomes

Not Applicable
Completed
Conditions
Cognitive Decline
Cognitive Change
Inflammation
Emotions
Interventions
Other: Yogurt
Registration Number
NCT04643080
Lead Sponsor
University of Idaho
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
47
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
YogurtYogurtSubjects were asked to consume 6 oz. of yogurt daily for 12 weeks.
Primary Outcome Measures
NameTimeMethod
Change in Processing Speed from Baseline to 12-weeksChange 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-weeksChange 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-weeksChange 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-weeksChange 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-weeksChange 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-weeksChange 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.

Secondary Outcome Measures
NameTimeMethod
Change in Social Satisfaction from Baseline to 12-weeksChange from baseline social satisfaction test scores at 12 weeks

Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Social Satisfaction summary score was derived from 5 individual assessments of friendship, loneliness, emotional support, instrumental support, and perceived rejection.

Change in Psychological WellbeingChange from baseline psychological satisfaction test scores at 12 weeks

Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Psychological Wellbeing summary score was derived from 3 individual assessments of life satisfaction, meaning, and positive affect.

Change in Negative Affect from Baseline to 12-weeksChange from baseline negative affect test scores at 12 weeks

Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Negative Affect summary score was derived from 5 individual assessments of anger affect, anger hostility, sadness, fear affect, and perceived stress.

Change in serum interleukin-6 concentration from baseline to 12 weeksChange from baseline serum interleukin-6 concentration at 12 weeks

Serum samples were analyzed to determine concentrations of interleukin-6 (pg/mL).

Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeksChange from baseline serum tumor necrosis factor-alpha concentration at 12 weeks

Serum samples were analyzed to determine concentrations of tumor necrosis factor-alpha (pg/mL).

Change in serum c-reactive protein concentration from baseline to 12 weeksChange from baseline serum c-reactive protein concentration at 12 weeks

Serum samples were analyzed to determine concentrations of c-reactive protein (mg/L).

Trial Locations

Locations (2)

Kansas State University

🇺🇸

Manhattan, Kansas, United States

University of Idaho

🇺🇸

Pocatello, Idaho, United States

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