Effects of Probiotics on Cognition and Health (EPOCH)

The Effects of Probiotics on Behavioral and Biological Markers of Cognition and Stress

This research intervention aims to examine the effects of a fermented dairy beverage on changes in behavioral and biological measures of cognition and stress among adults.

Study Overview

• Status: Completed
• Conditions: Physiological Stress; Cognition - Other
• Intervention / Treatment: Other: Lactose Free 1% Milk; Other: Probiotic Treatment

Detailed Description

Evidence-based dietary strategies provide behavioral means benefiting physical and cognitive function. Pertinent to the proposed work, dietary intake has been recently shown to have the potential to directly influence the gut microbiota composition as well as brain function. Specifically, the consumption of probiotics or foods containing healthful microbial cultures (e.g., fermented milk, yogurts, etc.) are increasingly being recognized as modulators of metabolism, cognition, and stress. These foods are readily available in the marketplace, however, their implications for physical and cognitive function are not clear. Accordingly, the proposed study aims to investigate effects of probiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • University of Illinois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females
• Between the ages of 25-45 years at the time of consent
• BMI ≥18.5 kg/m2
• Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task.
• Ability to drop-off fecal sample within 15 minutes of defecation

Exclusion Criteria:

• Current pregnancy or lactation
• Tobacco use
• Dairy allergy or intolerance
• Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
• Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease
• Use of any anti-psychotic, anti-depressant, anti-anxiety, or ADD/ADHD medications
• Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants).
• Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Lactose free 1% milk; Diet will be recorded with a 7-day diet record and participants will include an isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.	Other: Lactose Free 1% Milk; isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.
Experimental: Probiotic treatment; Diet will be recorded with a 7-day diet record and participants will include an isocaloric fermented milk (probiotic), consumed once daily, over 4-5 weeks.	Other: Probiotic Treatment; Probiotic treatment, consumed once daily, over 4-5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cortisol as a biomarker of stress	The effects of probiotic consumption on biomarkers of stress	4-5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fecal microbiota populations	The effects of probiotic consumption on fecal microbiota	4-5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cognition	The effects of probioticconsumption on cognition	4-5 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Hannah Holscher, Ph.D., University of Illinois at Urbana-Champaign; Principal Investigator: Naiman Khan, Ph.D., University of Illinois at Urbana-Champaign

Publications and helpful links

General Publications

• Cannavale CN, Mysonhimer AR, Bailey MA, Cohen NJ, Holscher HD, Khan NA. Consumption of a fermented dairy beverage improves hippocampal-dependent relational memory in a randomized, controlled cross-over trial. Nutr Neurosci. 2023 Mar;26(3):265-274. doi: 10.1080/1028415X.2022.2046963. Epub 2022 Mar 13.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16840-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be disseminated by journal articles, thesis or academic papers, conference presentations, and sharing with the funding organization. No subject's identity will be disclosed in any presentation or released without their written permission.