Effects of Probiotics on Cognition and Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Probiotics on Behavioral and Biological Markers of Cognition and Stress

Conditions
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Physiological Stress, Cognition - Other

Intervention / Treatment
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* Other: Lactose Free 1% Milk
* Other: Probiotic Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will pass through 2 arms, control and probiotic, in a randomized, counter-balanced order.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lactose free 1% milk<br>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. | Other: Lactose Free 1% Milk<br>* isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.<br>|
| Experimental: Probiotic treatment<br>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. | Other: Probiotic Treatment<br>* Probiotic treatment, consumed once daily, over 4-5 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cortisol as a biomarker of stress | The effects of probiotic consumption on biomarkers of stress | 4-5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fecal microbiota populations | The effects of probiotic consumption on fecal microbiota | 4-5 weeks |