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CompletedNCT04551937EPOCH-2Updated Sep 16, 2020

Effects of Prebiotics on Cognition and Health

An interventional study of Lactose Free 1% Milk and Lactose Free 1% Milk + 10 g prebiotic in Physiological Stress, Cognitive Change and Gastrointestinal Health, sponsored by University of Illinois at Urbana-Champaign. Completed at 1 site in United States. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2018, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Physiological Stress
  • Cognitive Change
  • Gastrointestinal Health
03

In context

Lead sponsor

University of Illinois at Urbana-Champaign is the lead sponsor of 188 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    Control

    4-5 week period where participant will consume control beverage

    Other: Lactose Free 1% Milk

  • Experimental
    Prebiotic

    4-5 week period where participant will consume the intervention beverage

    Other: Lactose Free 1% Milk + 10 g prebiotic

Interventions

  • OtherLactose Free 1% Milk

    8 oz of study beverage daily

    Also known as: Control

  • OtherLactose Free 1% Milk + 10 g prebiotic

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

06

What researchers measure

Primary outcomes

  1. Biological markers of stress

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

    Time frame: 4-5 weeks

  2. Behavioral markers of stress

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

    Time frame: 4-5 weeks

Secondary outcomes

  1. Gastrointestinal Microbiota composition

    Impact on bacterial genera abundances.

    Time frame: 4-5 weeks

  2. Gastrointestinal microbiota beta-diversity

    Impact on beta-diversity measures

    Time frame: 4-5 weeks

  3. Gastrointestinal Microbiota alpha-diversity

    Impact on alpha-diversity measures

    Time frame: 4-5 weeks

  4. Cognitive function

    Computer tasks will be used to assess working memory, interference control, cognitive flexibility, and hippocampal function/relational memory

    Time frame: 4-5 weeks

  5. Sleep

    The Pittsburg Sleep Quality Index (PSQI) will also be used to assess sleep, as will actigraphy.

    Time frame: 4-5 weeks

07

Study locations

1 site
  • University of Illinois
    Urbana, Illinois 61801, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04551937
Lead sponsor
University of Illinois at Urbana-Champaign
Responsible party
Hannah Holscher (Assistant Professor of Nutrition, University of Illinois at Urbana-Champaign) — Principal investigator
First posted
Sep 16, 2020
Start date
Feb 14, 2018
Primary completion
Sep 18, 2018
Completion
Sep 18, 2018
Last update
Sep 16, 2020

Study contacts

Hannah Holscher, PhD, RD
principal investigator · University of Illinois at Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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