Skip to main content
OpenTrials
Completed

NCT Number: NCT04643080

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Change Cognitive Dysfunction Emotions Inflammation Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Idaho, Boise, Idaho, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Yogurt

Other

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

Primary outcomes

  1. Change in Fluid Cognition Composite from Baseline to 12-weeks

    Time frame: 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.

  2. Change in Executive Function from Baseline to 12-weeks

    Time frame: 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.

  3. Change in Attention from Baseline to 12-weeks

    Time frame: 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.

  4. Change in Working Memory from Baseline to 12-weeks

    Time frame: 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.

  5. Change in Processing Speed from Baseline to 12-weeks

    Time frame: 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.

  6. Change in Episodic Memory from Baseline to 12-weeks

    Time frame: 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.

Secondary outcomes

  1. Change in Negative Affect from Baseline to 12-weeks

    Time frame: Change 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.

  2. Change in Psychological Wellbeing

    Time frame: Change 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.

  3. Change in Social Satisfaction from Baseline to 12-weeks

    Time frame: Change 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.

  4. Change in serum interleukin-6 concentration from baseline to 12 weeks

    Time frame: Change from baseline serum interleukin-6 concentration at 12 weeks

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

  5. Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks

    Time frame: Change 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).

  6. Change in serum c-reactive protein concentration from baseline to 12 weeks

    Time frame: Change from baseline serum c-reactive protein concentration at 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of Idaho

Other

Collaborators

  • Kansas State University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.