Clinical trial NCT02849275: Effects of Probiotics on Cognition and Health
Official title: The Effects of Probiotics on Behavioral and Biological Markers of Cognition and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress
Cognition - Other
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will pass through 2 arms, control and probiotic, in a randomized, counter-balanced order.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in cortisol as a biomarker of stress
timeFrame: 4-5 weeks
Secondary outcomes:
measure: Changes in fecal microbiota populations
timeFrame: 4-5 weeks
Other outcomes:
measure: Changes in cognition
timeFrame: 4-5 weeks
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Hannah Holscher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Naiman Khan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cannavale CN, Mysonhimer AR, Bailey MA, Cohen NJ, Holscher HD, Khan NA. Consumption of a fermented dairy beverage improves hippocampal-dependent relational memory in a randomized, controlled cross-over trial. Nutr Neurosci. 2023 Mar;26(3):265-274. doi: 10.1080/1028415X.2022.2046963. Epub 2022 Mar 13.