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OpenTrials
Completed

NCT Number: NCT04551937

Effects of Prebiotics on Cognition and Health

This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois

Urbana, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lactose Free 1% Milk

Other

8 oz of study beverage daily

Other names: Control

Lactose Free 1% Milk + 10 g prebiotic

Other

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

Primary outcomes

  1. Biological markers of stress

    Time frame: 4-5 weeks

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

  2. 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

  1. Gastrointestinal Microbiota composition

    Time frame: 4-5 weeks

    Impact on bacterial genera abundances.

  2. Gastrointestinal microbiota beta-diversity

    Time frame: 4-5 weeks

    Impact on beta-diversity measures

  3. Gastrointestinal Microbiota alpha-diversity

    Time frame: 4-5 weeks

    Impact on alpha-diversity measures

  4. 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

  5. Sleep

    Time frame: 4-5 weeks

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

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

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

Acronym: EPOCH-2

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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