The Effects of Probiotics on Behavioral and Biological Markers of Cognition and Stress
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Changes in cortisol as a biomarker of stress
Study Overview
Brief Summary
This research intervention aims to examine the effects of a fermented dairy beverage 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 probiotics or foods containing healthful microbial cultures (e.g., fermented milk, yogurts, etc.) are increasingly being recognized as modulators of metabolism, cognition, and stress. 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 probiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- 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
- •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, anti-anxiety, 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, antacids, antispasmodics, diuretics, anticonvulsants).
- •Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years.
Arms & Interventions
Lactose free 1% milk
Diet will be recorded with a 7-day diet record and participants will include an isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.
Intervention: Lactose Free 1% Milk (Other)
Probiotic treatment
Diet will be recorded with a 7-day diet record and participants will include an isocaloric fermented milk (probiotic), consumed once daily, over 4-5 weeks.
Intervention: Probiotic Treatment (Other)
Outcomes
Primary Outcomes
Changes in cortisol as a biomarker of stress
Time Frame: 4-5 weeks
The effects of probiotic consumption on biomarkers of stress
Secondary Outcomes
- Changes in fecal microbiota populations(4-5 weeks)
Investigators
Hannah Holscher
Assistant Professor of Nutrition
University of Illinois at Urbana-Champaign