Effects of Probiotics on Cognition and Health

Not Applicable

Completed

• Conditions: Physiological Stress; Cognition - Other
• Interventions: Other: Probiotic Treatment; Other: Lactose Free 1% Milk

• Registration Number: NCT02849275
• Lead Sponsor: University of Illinois at Urbana-Champaign

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 Timeline

• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Study Start: 2016-08
• Status Verified: 2018-07
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotic treatment	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.
Lactose free 1% milk	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.

Primary Outcome Measures

Name	Time	Method
Changes in cortisol as a biomarker of stress	4-5 weeks	The effects of probiotic consumption on biomarkers of stress

Secondary Outcome Measures

Name	Time	Method
Changes in fecal microbiota populations	4-5 weeks	The effects of probiotic consumption on fecal microbiota

Trial Locations

Locations (1)

University of Illinois; 🇺🇸 Urbana, Illinois, United States