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

NCT04643080 | Completed

• 1 other identifier: 18-203
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

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.

Conditions

Cognitive Decline; Cognitive Change; Inflammation; Emotions

Keywords

Probiotics; Cognition; Emotional Wellbeing; Inflammation; Older Adults; Yogurt

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Change in Negative Affect from Baseline to 12-weeks

  Change from baseline negative affect test scores at 12 weeks

• Change in Psychological Wellbeing

  Change from baseline psychological satisfaction test scores at 12 weeks

• Change in Social Satisfaction from Baseline to 12-weeks

  Change from baseline social satisfaction test scores at 12 weeks

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

  Change from baseline serum interleukin-6 concentration at 12 weeks

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Yogurt

EXPERIMENTAL

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

Other: Yogurt

Interventions

Yogurt OTHER

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

Yogurt

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Idaho: lead
• Kansas State University: collaborator

Study Sites (4)

University of Idaho

Boise, Idaho, 83702, United States

Location

University of Idaho

Coeur d'Alene, Idaho, 83814, United States

Location

University of Idaho

Pocatello, Idaho, 83201, United States

Location

Kansas State University

Manhattan, Kansas, 66506, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Inflammation

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 24, 2020
• Study Start: March 7, 2019
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)