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Clinical Trials/NCT04551937
NCT04551937
Completed
Not Applicable

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

University of Illinois at Urbana-Champaign1 site in 1 country24 target enrollmentFebruary 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physiological Stress
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
24
Locations
1
Primary Endpoint
Biological markers of stress
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2018
End Date
September 18, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hannah Holscher

Assistant Professor of Nutrition

University of Illinois at Urbana-Champaign

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Biological markers of stress

Time Frame: 4-5 weeks

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

Behavioral markers of stress

Time Frame: 4-5 weeks

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

Secondary Outcomes

  • Gastrointestinal Microbiota composition(4-5 weeks)
  • Cognitive function(4-5 weeks)
  • Gastrointestinal Microbiota alpha-diversity(4-5 weeks)
  • Gastrointestinal microbiota beta-diversity(4-5 weeks)
  • Sleep(4-5 weeks)

Study Sites (1)

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