Effects of Prebiotics on Cognition and Health

Cognitive Change Clinical Trial

— EPOCH-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551937
• Other study ID #: 16840
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: September 18, 2018

Study information

• Verified date: September 2020
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 18, 2018
• Est. primary completion date: September 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Change
• Gastrointestinal Health
• Physiological Stress

Intervention

Other:
• Lactose Free 1% Milk
8 oz of study beverage daily
• Lactose Free 1% Milk + 10 g prebiotic
8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide

Locations

Country	Name	City	State
United States	University of Illinois	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological markers of stress	Changes in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP).	4-5 weeks
Primary	Behavioral markers of stress	Change in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire.	4-5 weeks
Secondary	Gastrointestinal Microbiota composition	Impact on bacterial genera abundances.	4-5 weeks
Secondary	Gastrointestinal microbiota beta-diversity	Impact on beta-diversity measures	4-5 weeks
Secondary	Gastrointestinal Microbiota alpha-diversity	Impact on alpha-diversity measures	4-5 weeks
Secondary	Cognitive function	Computer tasks will be used to assess working memory, interference control, cognitive flexibility, and hippocampal function/relational memory	4-5 weeks
Secondary	Sleep	The Pittsburg Sleep Quality Index (PSQI) will also be used to assess sleep, as will actigraphy.	4-5 weeks