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

Sponsor

University of Idaho (Other)

Overall Status

Completed

CT.gov ID

NCT04643080

Collaborator

Kansas State University (Other)

Enrollment

Locations

Arms

4.3

Actual Duration (Months)

11.8

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Decline Cognitive Change Inflammation Emotions	Other: Yogurt	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 7, 2019

Actual Primary Completion Date :

Jul 15, 2019

Actual Study Completion Date :

Jul 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Fluid Cognition Composite from Baseline to 12-weeks [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.
Change in Executive Function from Baseline to 12-weeks [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.
Change in Attention from Baseline to 12-weeks [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.
Change in Working Memory from Baseline to 12-weeks [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.
Change in Processing Speed from Baseline to 12-weeks [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.
Change in Episodic Memory from Baseline to 12-weeks [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 Outcome Measures

Change in Negative Affect from Baseline to 12-weeks [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.
Change in Psychological Wellbeing [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.
Change in Social Satisfaction from Baseline to 12-weeks [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.
Change in serum interleukin-6 concentration from baseline to 12 weeks [Change 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 weeks [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).
Change in serum c-reactive protein concentration from baseline to 12 weeks [Change from baseline serum c-reactive protein concentration at 12 weeks]
Serum samples were analyzed to determine concentrations of c-reactive protein (mg/L).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Idaho	Boise	Idaho	United States	83702
2	University of Idaho	Coeur d'Alene	Idaho	United States	83814
3	University of Idaho	Pocatello	Idaho	United States	83201
4	Kansas State University	Manhattan	Kansas	United States	66506