Prebiotic and Probiotic Modulation of the Gut Microbiota-... | NCT05392556

NCT05392556

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
M-10901	Other Identifier	HQ US Army MRDC IRB

Status Module

Name	Class
United States Army Combat Capabilities Development Command Soldier Center	UNKNOWN
United States Air Force Research Laboratory	FED

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Experimental	Bifidobacterium longum R0175; Lactobacillus helveticus R0052 (Cerebiome; Lallemand Health Solutions)	Dietary Supplement: Probiotic
Prebiotic	Experimental	Bimuno-galactooligosaccharide (Bimuno-GOS; Clasado Biosciences)	Dietary Supplement: Prebiotic
Placebo	Placebo Comparator	Maltodextrin placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	Cerebiome (Lallemand Health Solutions): probiotic supplement containing Bifidobacterium longum R0175, Lactobacillus helveticus R0052, and maltodextrin. Dosing: Oral, 3.6 g/d containing 3x10^9 CFU/d (powder form)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in intestinal permeability	A differential sugar absorption test will be used to assess intestinal permeability. Participants will consume 2g sucralose and 4g mannitol dissolved in 180 mL water prior to starting exercise. Participants will then collect all urine produced over the subsequent 4hr. Urine sucralose and mannitol concentrations will be analyzed.	Days 0 and 29
Difference from baseline in circulating cortisol concentrations	Serum cortisol concentrations will be measured in serial blood samples collected via an indwelling venous catheter.	Before (-20min), during (60min) and immediately after (120min) exercise and immediately before and after cognitive stress exposure on days 0 and 29.

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in mean heart rate variability	Heart rate variability will be measured using a chest-worn heart rate monitor.	During stress exposure (up to 4hr) on days 0 and 29.
Change from baseline in performance on decision making under conditions of ambiguity task

Other Outcomes

Measure	Description	Time Frame
Change from baseline in mean heart rate	Heart rate will be measured using a chest-worn heart rate monitor.	During stress exposure (up to 4hr) on days 0 and 29
Change from baseline in exercise energy expenditure

Eligibility Module

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

ID	Term
D019936	Probiotics
D056692	Prebiotics

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena