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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Cognitive Change; Cognitive Decline; Emotions
• Intervention / Treatment: Other: Yogurt

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83702
      • University of Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • University of Idaho
    • Pocatello, Idaho, United States, 83201
      • University of Idaho
  • Kansas
    • Manhattan, Kansas, United States, 66506
      • Kansas State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects were asked to avoid consuming fermented foods for 12 weeks.
Experimental: Yogurt; Subjects were asked to consume 6 oz. of yogurt daily for 12 weeks.	Other: Yogurt; 6 oz. of a commercially available yogurt were provided daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fluid Cognition Composite from Baseline to 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 from baseline fluid cognition composite score at 12-weeks
Change in Executive Function from Baseline to 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 from baseline executive function test scores at 12 weeks
Change in Attention from Baseline to 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 from baseline attention test scores at 12 weeks
Change in Working Memory from Baseline to 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.	Change from baseline working memory test scores at 12 weeks
Change in Processing Speed from Baseline to 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 from baseline processing speed test scores at 12 weeks
Change in Episodic Memory from Baseline to 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 baseline episodic memory score at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Negative Affect from Baseline to 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 from baseline negative affect test scores at 12 weeks
Change in Psychological Wellbeing	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 from baseline psychological satisfaction test scores at 12 weeks
Change in Social Satisfaction from Baseline to 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 from baseline social satisfaction test scores at 12 weeks
Change in serum interleukin-6 concentration from baseline to 12 weeks	Serum samples were analyzed to determine concentrations of interleukin-6 (pg/mL).	Change from baseline serum interleukin-6 concentration at 12 weeks
Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks	Serum samples were analyzed to determine concentrations of tumor necrosis factor-alpha (pg/mL).	Change from baseline serum tumor necrosis factor-alpha concentration at 12 weeks
Change in serum c-reactive protein concentration from baseline to 12 weeks	Serum samples were analyzed to determine concentrations of c-reactive protein (mg/L).	Change from baseline serum c-reactive protein concentration at 12 weeks

Collaborators and Investigators

• Sponsor: University of Idaho
• Collaborators: Kansas State University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; Probiotics; Older Adults; Cognition; Yogurt; Emotional Wellbeing
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Inflammation; Cognitive Dysfunction
• Other Study ID Numbers: 18-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small pilot study and there are not intentions to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No