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

Primary Purpose

Cognitive Decline, Cognitive Change, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yogurt
Sponsored by
University of Idaho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Decline focused on measuring Probiotics, Cognition, Emotional Wellbeing, Inflammation, Older Adults, Yogurt

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • University of Idaho
  • University of Idaho
  • University of Idaho
  • Kansas State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Yogurt

Arm Description

Subjects were asked to avoid consuming fermented foods for 12 weeks.

Subjects were asked to consume 6 oz. of yogurt daily for 12 weeks.

Outcomes

Primary Outcome Measures

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 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 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 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 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 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.

Secondary Outcome Measures

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 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 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 in serum interleukin-6 concentration from baseline to 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 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 weeks
Serum samples were analyzed to determine concentrations of c-reactive protein (mg/L).

Full Information

First Posted
November 16, 2020
Last Updated
November 20, 2020
Sponsor
University of Idaho
Collaborators
Kansas State University
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1. Study Identification

Unique Protocol Identification Number
NCT04643080
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Idaho
Collaborators
Kansas State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Cognitive Change, Inflammation, Emotions
Keywords
Probiotics, Cognition, Emotional Wellbeing, Inflammation, Older Adults, Yogurt

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects were asked to avoid consuming fermented foods for 12 weeks.
Arm Title
Yogurt
Arm Type
Experimental
Arm Description
Subjects were asked to consume 6 oz. of yogurt daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Yogurt
Intervention Description
6 oz. of a commercially available yogurt were provided daily for 12 weeks
Primary Outcome Measure Information:
Title
Change in Fluid Cognition Composite from Baseline to 12-weeks
Description
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.
Time Frame
Change from baseline fluid cognition composite score at 12-weeks
Title
Change in Executive Function from Baseline to 12-weeks
Description
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.
Time Frame
Change from baseline executive function test scores at 12 weeks
Title
Change in Attention from Baseline to 12-weeks
Description
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.
Time Frame
Change from baseline attention test scores at 12 weeks
Title
Change in Working Memory from Baseline to 12-weeks
Description
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.
Time Frame
Change from baseline working memory test scores at 12 weeks
Title
Change in Processing Speed from Baseline to 12-weeks
Description
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.
Time Frame
Change from baseline processing speed test scores at 12 weeks
Title
Change in Episodic Memory from Baseline to 12-weeks
Description
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.
Time Frame
Change in baseline episodic memory score at 12 weeks
Secondary Outcome Measure Information:
Title
Change in Negative Affect from Baseline to 12-weeks
Description
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.
Time Frame
Change from baseline negative affect test scores at 12 weeks
Title
Change in Psychological Wellbeing
Description
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.
Time Frame
Change from baseline psychological satisfaction test scores at 12 weeks
Title
Change in Social Satisfaction from Baseline to 12-weeks
Description
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.
Time Frame
Change from baseline social satisfaction test scores at 12 weeks
Title
Change in serum interleukin-6 concentration from baseline to 12 weeks
Description
Serum samples were analyzed to determine concentrations of interleukin-6 (pg/mL).
Time Frame
Change from baseline serum interleukin-6 concentration at 12 weeks
Title
Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks
Description
Serum samples were analyzed to determine concentrations of tumor necrosis factor-alpha (pg/mL).
Time Frame
Change from baseline serum tumor necrosis factor-alpha concentration at 12 weeks
Title
Change in serum c-reactive protein concentration from baseline to 12 weeks
Description
Serum samples were analyzed to determine concentrations of c-reactive protein (mg/L).
Time Frame
Change from baseline serum c-reactive protein concentration at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Facility Information:
Facility Name
University of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
University of Idaho
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
University of Idaho
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83201
Country
United States
Facility Name
Kansas State University
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a small pilot study and there are not intentions to make individual participant data available to other researchers.

Learn more about this trial

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

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