Effects of Prebiotics on Cognition and Health (EPOCH-2)

University of Illinois at Urbana-Champaign

Status: Completed

Conditions: Cognitive Change; Physiological Stress; Gastrointestinal Health

Treatments: Other: Lactose Free 1% Milk; Other: Lactose Free 1% Milk + 10 g prebiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04551937

16840

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

4-5 week period where participant will consume control beverage

Treatment:

Other: Lactose Free 1% Milk

Prebiotic

Experimental group

Description:

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

Treatment:

Other: Lactose Free 1% Milk + 10 g prebiotic