EPOCH-2: Effects of Prebiotics on Cognition and Health

• Sponsor: University of Illinois at Urbana-Champaign (Other)
• Overall Status: Completed
• CT.gov ID: NCT04551937
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.

Condition or Disease	Intervention/Treatment	Phase
Physiological Stress; Cognitive Change; Gastrointestinal Health	Other: Lactose Free 1% Milk; Other: Lactose Free 1% Milk + 10 g prebiotic	N/A

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 prebiotics or fibers metabolized by gut bacteria may also play a role. 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 prebiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will pass through 2 arms, control and prebiotic, in a randomized, counterbalanced order.Participants will pass through 2 arms, control and prebiotic, in a randomized, counterbalanced order.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blind (participant and investigative team)
• Primary Purpose: Basic Science
• Official Title: The Effects of Prebiotics on Behavioral and Biological Markers of Cognition and Stress
• Actual Study Start Date: Feb 14, 2018
• Actual Primary Completion Date: Sep 18, 2018
• Actual Study Completion Date: Sep 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control 4-5 week period where participant will consume control beverage	Other: Lactose Free 1% Milk; 8 oz of study beverage daily; Other Names: Control
Experimental: Prebiotic 4-5 week period where participant will consume the intervention beverage	Other: Lactose Free 1% Milk + 10 g prebiotic; 8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide

Outcome Measures

Primary Outcome Measures

1. Biological markers of stress [4-5 weeks]

   Changes in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP).

2. Behavioral markers of stress [4-5 weeks]

   Change in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire.

Secondary Outcome Measures

1. Gastrointestinal Microbiota composition [4-5 weeks]

   Impact on bacterial genera abundances.

2. Gastrointestinal microbiota beta-diversity [4-5 weeks]

   Impact on beta-diversity measures

3. Gastrointestinal Microbiota alpha-diversity [4-5 weeks]

   Impact on alpha-diversity measures

4. Cognitive function [4-5 weeks]

   Computer tasks will be used to assess working memory, interference control, cognitive flexibility, and hippocampal function/relational memory

5. Sleep [4-5 weeks]

   The Pittsburg Sleep Quality Index (PSQI) will also be used to assess sleep, as will actigraphy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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, antianxiety, 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, antispasmodics, diuretics, anticonvulsants).

• Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois	Urbana	Illinois	United States	61801

Sponsors and Collaborators

• University of Illinois at Urbana-Champaign

Investigators

• Principal Investigator: Hannah Holscher, PhD, RD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hannah Holscher, Assistant Professor of Nutrition, University of Illinois at Urbana-Champaign
• ClinicalTrials.gov Identifier: NCT04551937
• Other Study ID Numbers: 16840
• First Posted: Sep 16, 2020
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 16, 2020