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Effects of Probiotics on Cognition and Health (EPOCH)

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ClinicalTrials.gov Identifier: NCT02849275
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hannah Holscher, 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.

Condition or disease Intervention/treatment Phase
Physiological Stress Cognition - Other Other: Lactose Free 1% Milk Other: Probiotic Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will pass through 2 arms, control and probiotic, in a randomized, counter-balanced order.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Probiotics on Behavioral and Biological Markers of Cognition and Stress
Study Start Date : August 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Arm Intervention/treatment
Placebo Comparator: 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.
Other: Lactose Free 1% Milk
isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.

Experimental: 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.
Other: Probiotic Treatment
Probiotic treatment, consumed once daily, over 4-5 weeks.




Primary Outcome Measures :
  1. Changes in cortisol as a biomarker of stress [ Time Frame: 4-5 weeks ]
    The effects of probiotic consumption on biomarkers of stress


Secondary Outcome Measures :
  1. Changes in fecal microbiota populations [ Time Frame: 4-5 weeks ]
    The effects of probiotic consumption on fecal microbiota


Other Outcome Measures:
  1. Changes in cognition [ Time Frame: 4-5 weeks ]
    The effects of probioticconsumption on cognition



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849275


Locations
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United States, Illinois
University of Illinois
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Hannah Holscher, Ph.D. University of Illinois at Urbana-Champaign
Principal Investigator: Naiman Khan, Ph.D. University of Illinois at Urbana-Champaign

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Responsible Party: Hannah Holscher, Assistant Professor of Nutrition, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02849275     History of Changes
Other Study ID Numbers: 16840-1
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be disseminated by journal articles, thesis or academic papers, conference presentations, and sharing with the funding organization. No subject's identity will be disclosed in any presentation or released without their written permission.