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Effects of Prebiotics on Cognition and Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04551937
Acronym
EPOCH-2
Enrollment
24
Registered
2020-09-16
Start date
2018-02-14
Completion date
2018-09-18
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiological Stress, Cognitive Change, Gastrointestinal Health

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.

Interventions

8 oz of study beverage daily

OTHERLactose Free 1% Milk + 10 g prebiotic

8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blind (participant and investigative team)

Intervention model description

Participants will pass through 2 arms, control and prebiotic, in a randomized, counterbalanced order.

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Biological markers of stress4-5 weeksChanges in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP).
Behavioral markers of stress4-5 weeksChange in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire.

Secondary

MeasureTime frameDescription
Cognitive function4-5 weeksComputer tasks will be used to assess working memory, interference control, cognitive flexibility, and hippocampal function/relational memory
Gastrointestinal microbiota beta-diversity4-5 weeksImpact on beta-diversity measures
Gastrointestinal Microbiota composition4-5 weeksImpact on bacterial genera abundances.
Sleep4-5 weeksThe Pittsburg Sleep Quality Index (PSQI) will also be used to assess sleep, as will actigraphy.
Gastrointestinal Microbiota alpha-diversity4-5 weeksImpact on alpha-diversity measures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026