Effects of Probiotics on Cognition and Health

Physiological Stress Clinical Trial

— EPOCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849275
• Other study ID #: 16840-1
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2018
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition - Other
• Physiological Stress

Intervention

Other:
• Lactose Free 1% Milk
isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.
• Probiotic Treatment
Probiotic treatment, consumed once daily, over 4-5 weeks.

Locations

Country	Name	City	State
United States	University of Illinois	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in cognition	The effects of probioticconsumption on cognition	4-5 weeks
Primary	Changes in cortisol as a biomarker of stress	The effects of probiotic consumption on biomarkers of stress	4-5 weeks
Secondary	Changes in fecal microbiota populations	The effects of probiotic consumption on fecal microbiota	4-5 weeks