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Clinical Trial Summary

Emerging evidence supports the existence of a microbiota-gut-brain axis through which gut microbes influence cognition, mood and behavior. Targeting this axis with probiotics and/or prebiotics may provide novel strategies for mitigating stress-induced decrements in gastrointestinal and cognitive function. This double-blind, placebo-controlled, randomized, parallel-arm trial will determine the effects of a prebiotic and a probiotic dietary intervention on gastrointestinal, cognitive and physiologic responses to acute military-relevant physical and cognitive stress. Healthy men and women will be recruited and randomized to receive a placebo, probiotic or prebiotic for 4wk. Volunteers will be fed a controlled diet during the 4th week of supplementation. Fecal, blood, urine and saliva samples will be collected. Physical stress will be induced by a weighted walk on a treadmill, and will be followed by a cognitively challenging testing scenario that uses intermittent electric shocks to the abdomen to induce a stress response.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05392556
Study type Interventional
Source United States Army Research Institute of Environmental Medicine
Contact J. Philip Karl, PhD, RD
Phone 508-206-2318
Email james.p.karl.civ@health.mil
Status Recruiting
Phase N/A
Start date July 6, 2022
Completion date December 2024

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