RECRUITING

Prebiotic and Probiotic Modulation of the Gut Microbiota-gut-brain Axis During Acute Stress

Conditions

Stress Physiology Probiotic Prebiotic Microbiome Stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prebiotic and Probiotic Modulation of the Gut Microbiota-gut-brain Axis During Acute Stress

Quick Facts

Study Start:2022-07-06

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05392556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:17 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Men and women aged 18 - 39 years (active duty personnel who are 17 yr of age will also be allowed to participate). * In good health as determined by Medical Clearance. * Physically active: * Meet Army weight for height and body composition standards as defined in Army Regulation 600-9: * Self-reports ≥4 bowel movements/week. * Self-reports normal hearing. * Willing to maintain usual diet until provided diet phase of study.	* Pregnant, expecting to become pregnant during study, or breastfeeding. * Abnormal menstrual cycles \[i.e., not between 26-32 days in duration; or not 5-6 menstrual cycles within the past 6 months\], or those that have had an IUD placed within the last month or removed within the past 3 months. * Less than 20/20 acuity on the Snellen eye chart of normal or corrected-to-normal acuity. * Any of the following medical conditions: * Colonoscopy within 3 months of study participation. * Any use of antibiotics or antimycotics, except topical antibiotics/antimycotics, within 3 months of study participation. * Regular use of over-the-counter medications (including antacids, laxatives, stool softeners, and anti-diarrheals) unless approved by medical office and study PI. * Taking prescription medications other than a contraceptive (unless approved by medical office and study PI) * Not willing or able to refrain from using over the counter medications for 72hr before stress exposure days. * Not willing or able to stop consumption of dietary supplements at least 2 weeks before and throughout study participation. * Not willing or able to stop consumption of probiotic-containing foods (e.g., yogurt, etc.) or foods containing added prebiotics (e.g., inulin) at least 2 weeks before and throughout study participation. * Not willing to abstain from non-provided foods and beverages, including alcohol, during the controlled-diet period. * Not willing to abstain from caffeine and any nicotine containing products (smoking, chewing, vaping, etc.) during the week prior to stress exposure days. * Not willing to refrain from strenuous exercise for 24hr prior to stress exposure days. * Allergies, intolerances, unwillingness or inability to eat intervention supplements, or provided foods and beverages. * Following vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet). * Any previous blood donation, within 8 weeks of a study blood draw, of a volume that when combined with the amount of blood to be collected during the study would exceed 550 mL

Inclusion Criteria

Exclusion Criteria

* Men and women aged 18 - 39 years (active duty personnel who are 17 yr of age will also be allowed to participate).
* In good health as determined by Medical Clearance.
* Physically active:
* Meet Army weight for height and body composition standards as defined in Army Regulation 600-9:
* Self-reports ≥4 bowel movements/week.
* Self-reports normal hearing.
* Willing to maintain usual diet until provided diet phase of study.

* Pregnant, expecting to become pregnant during study, or breastfeeding.
* Abnormal menstrual cycles \[i.e., not between 26-32 days in duration; or not 5-6 menstrual cycles within the past 6 months\], or those that have had an IUD placed within the last month or removed within the past 3 months.
* Less than 20/20 acuity on the Snellen eye chart of normal or corrected-to-normal acuity.
* Any of the following medical conditions:
* Colonoscopy within 3 months of study participation.
* Any use of antibiotics or antimycotics, except topical antibiotics/antimycotics, within 3 months of study participation.
* Regular use of over-the-counter medications (including antacids, laxatives, stool softeners, and anti-diarrheals) unless approved by medical office and study PI.
* Taking prescription medications other than a contraceptive (unless approved by medical office and study PI)
* Not willing or able to refrain from using over the counter medications for 72hr before stress exposure days.
* Not willing or able to stop consumption of dietary supplements at least 2 weeks before and throughout study participation.
* Not willing or able to stop consumption of probiotic-containing foods (e.g., yogurt, etc.) or foods containing added prebiotics (e.g., inulin) at least 2 weeks before and throughout study participation.
* Not willing to abstain from non-provided foods and beverages, including alcohol, during the controlled-diet period.
* Not willing to abstain from caffeine and any nicotine containing products (smoking, chewing, vaping, etc.) during the week prior to stress exposure days.
* Not willing to refrain from strenuous exercise for 24hr prior to stress exposure days.
* Allergies, intolerances, unwillingness or inability to eat intervention supplements, or provided foods and beverages.
* Following vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet).
* Any previous blood donation, within 8 weeks of a study blood draw, of a volume that when combined with the amount of blood to be collected during the study would exceed 550 mL

Contacts and Locations

Study Contact

J. Philip Karl, PhD, RD

CONTACT

508-206-2318

james.p.karl.civ@health.mil

Heather S Fagnant, MS, MPH, RD

CONTACT

508-206-2283

heather.s.fagnant.civ@health.mil

Principal Investigator

J. Philip Karl, PhD, RD

PRINCIPAL_INVESTIGATOR

United States Army Research Institute of Environmental Medicine

Study Locations (Sites)

United States Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760

United States

Collaborators and Investigators

Sponsor: United States Army Research Institute of Environmental Medicine

J. Philip Karl, PhD, RD, PRINCIPAL_INVESTIGATOR, United States Army Research Institute of Environmental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-06

Study Completion Date2024-12

Study Record Updates

Study Start Date2022-07-06

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

Probiotic
Prebiotic
Microbiome
Stress

Additional Relevant MeSH Terms

Stress Physiology