Modulating gut health to manage stress responses

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

This study is testing whether taking prebiotics or probiotics can help healthy young adults manage stress better by looking at how these supplements affect their gut and brain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 17 Years to 39 Years
• Sex: All
• Sponsor: United States Army Research Institute of Environmental Medicine (Federal)
• Locations: 1 site (Natick, Massachusetts)
• Trial ID: NCT05392556 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates how prebiotics and probiotics can influence the gut microbiota and its connection to the brain during periods of acute stress. Healthy men and women aged 18-39 will be randomly assigned to receive either a placebo, a probiotic, or a prebiotic for four weeks, followed by a controlled diet. Participants will undergo physical and cognitive stress tests, with various biological samples collected to assess the effects of the interventions on gastrointestinal and cognitive functions. The study aims to provide insights into the potential of dietary interventions in managing stress-related health issues.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18-39 who are physically active and meet specific health criteria.

Not a fit: Patients who are pregnant, breastfeeding, or have certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer new dietary strategies to help mitigate the negative effects of stress on gut and cognitive health.

How similar studies have performed: Other studies have shown promising results in using probiotics and prebiotics to influence gut health and stress responses, suggesting this approach has potential.

Eligibility criteria

Inclusion 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:

If military, passed most recent record Combat or Physical Fitness Test, and ≥4 d/wk aerobic and/or resistance exercise.

If civilian, ≥4 d/wk aerobic and/or resistance exercise.

* 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.

Exclusion Criteria:

* 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:

Neurological or psychological disorder (such as depression, anxiety disorders, migraines, cluster headaches, seizures, post-traumatic stress disorder or panic attacks).

Cardiac disease (including arrhythmia or fast or skipped heart beats) Hypertension Has a pacemaker Insomnia Musculoskeletal injuries that compromise exercise capability Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, etc.) Disease of the GI tract including, but not limited to diverticulitis, inflammatory bowel disease, irritable bowel syndrome, peptic ulcer disease, Crohn's disease, and ulcerative colitis Excessive alcohol use or other substance abuse issues Immunodeficiency disorder Allergy to skin adhesive

* 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

Where this trial is running

Natick, Massachusetts

• United States Army Research Institute of Environmental Medicine — Natick, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: J. Philip Karl, PhD, RD — United States Army Research Institute of Environmental Medicine
• Study coordinator: J. Philip Karl, PhD, RD

Conditions Stress Physiology; Probiotic; Prebiotic; Microbiome; Stress