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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643080
• Other study ID #: 18-203
• Status: Completed
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: November 2020
• Source: University of Idaho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Cognitive Change
• Cognitive Decline
• Cognitive Dysfunction
• Emotions
• Inflammation

Intervention

Other:
• Yogurt
6 oz. of a commercially available yogurt were provided daily for 12 weeks

Locations

Country	Name	City	State
United States	University of Idaho	Boise	Idaho
United States	University of Idaho	Coeur d'Alene	Idaho
United States	Kansas State University	Manhattan	Kansas
United States	University of Idaho	Pocatello	Idaho

Sponsors (2)

Lead Sponsor	Collaborator
University of Idaho	Kansas State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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