- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04551937
Effects of Prebiotics on Cognition and Health (EPOCH-2)
September 9, 2020 updated by: Hannah Holscher, University of Illinois at Urbana-Champaign
The Effects of Prebiotics on Behavioral and Biological Markers of Cognition and Stress
This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.
Study Overview
Status
Completed
Intervention / 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 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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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, 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control
4-5 week period where participant will consume control beverage
|
8 oz of study beverage daily
Other Names:
|
EXPERIMENTAL: Prebiotic
4-5 week period where participant will consume the intervention beverage
|
8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biological markers of stress
Time Frame: 4-5 weeks
|
Changes in 24-hour urinary cortisol, inflammatory markers (e.g.
IL-6, CRP).
|
4-5 weeks
|
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.
|
4-5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal Microbiota composition
Time Frame: 4-5 weeks
|
Impact on bacterial genera abundances.
|
4-5 weeks
|
Gastrointestinal microbiota beta-diversity
Time Frame: 4-5 weeks
|
Impact on beta-diversity measures
|
4-5 weeks
|
Gastrointestinal Microbiota alpha-diversity
Time Frame: 4-5 weeks
|
Impact on alpha-diversity measures
|
4-5 weeks
|
Cognitive function
Time Frame: 4-5 weeks
|
Computer tasks will be used to assess working memory, interference control, cognitive flexibility, and hippocampal function/relational memory
|
4-5 weeks
|
Sleep
Time Frame: 4-5 weeks
|
The Pittsburg Sleep Quality Index (PSQI) will also be used to assess sleep, as will actigraphy.
|
4-5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hannah Holscher, PhD, RD, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 14, 2018
Primary Completion (ACTUAL)
September 18, 2018
Study Completion (ACTUAL)
September 18, 2018
Study Registration Dates
First Submitted
July 6, 2018
First Submitted That Met QC Criteria
September 9, 2020
First Posted (ACTUAL)
September 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 16840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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