Cognitive Change Clinical Trial
— EPOCH-2Official title:
The Effects of Prebiotics on Behavioral and Biological Markers of Cognition and Stress
Verified date | September 2020 |
Source | University of Illinois at Urbana-Champaign |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign |
United States,
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 |
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