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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04643080
Enrollment
47
Registered
2020-11-24
Start date
2019-03-07
Completion date
2019-07-15
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Cognitive Change, Inflammation, Emotions

Keywords

Probiotics, Cognition, Emotional Wellbeing, Inflammation, Older Adults, Yogurt

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.

Interventions

OTHERYogurt

6 oz. of a commercially available yogurt were provided daily for 12 weeks

Sponsors

Kansas State University
CollaboratorOTHER
University of Idaho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Change in Episodic Memory from Baseline to 12-weeksChange in baseline episodic memory score at 12 weeksSubjects 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 Fluid Cognition Composite from Baseline to 12-weeksChange from baseline fluid cognition composite score at 12-weeksSubjects 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 Executive Function from Baseline to 12-weeksChange from baseline executive function test scores at 12 weeksSubjects 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 Attention from Baseline to 12-weeksChange from baseline attention test scores at 12 weeksSubjects 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 Working Memory from Baseline to 12-weeksChange from baseline working memory test scores at 12 weeksSubjects 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.
Change in Processing Speed from Baseline to 12-weeksChange from baseline processing speed test scores at 12 weeksSubjects 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.

Secondary

MeasureTime frameDescription
Change in Negative Affect from Baseline to 12-weeksChange from baseline negative affect test scores at 12 weeksSubjects 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 Psychological WellbeingChange from baseline psychological satisfaction test scores at 12 weeksSubjects 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 Social Satisfaction from Baseline to 12-weeksChange from baseline social satisfaction test scores at 12 weeksSubjects 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 serum interleukin-6 concentration from baseline to 12 weeksChange from baseline serum interleukin-6 concentration at 12 weeksSerum 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 weeksSerum 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 weeksSerum samples were analyzed to determine concentrations of c-reactive protein (mg/L).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026