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
|Condition or disease||Intervention/treatment||Phase|
|Physiological Stress Cognition - Other||Other: Lactose Free 1% Milk Other: Probiotic Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|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|
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.
- Changes in cortisol as a biomarker of stress [ Time Frame: 4-5 weeks ]The effects of probiotic consumption on biomarkers of stress
- Changes in fecal microbiota populations [ Time Frame: 4-5 weeks ]The effects of probiotic consumption on fecal microbiota
- Changes in cognition [ Time Frame: 4-5 weeks ]The effects of probioticconsumption on cognition
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
|United States, Illinois|
|University of Illinois|
|Urbana, Illinois, United States, 61801|
|Principal Investigator:||Hannah Holscher, Ph.D.||University of Illinois at Urbana-Champaign|
|Principal Investigator:||Naiman Khan, Ph.D.||University of Illinois at Urbana-Champaign|