Probiotic for Stress Physiology

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stress PhysiologyProbiotic - DietarySupplement
Eligibility
17 - 39
All Sexes
What conditions do you have?
Select

Study Summary

This trial will determine the effects of a prebiotic and probiotic dietary intervention on responses to physical and cognitive stress.

Treatment Effectiveness

Study Objectives

2 Primary · 28 Secondary · Reporting Duration: Before (-45min) exercise, after 40 and 100 min of exercise, and immediately after exercise on days 0 and 29

Day 0
Difference from baseline in circulating acetate concentrations
Difference from baseline in circulating butyrate concentrations
Difference from baseline in circulating glucose concentrations
Difference from baseline in circulating lactate concentrations
Difference from baseline in circulating propionate concentrations
Day 0
Difference from baseline in circulating metabolite levels
Day 0
Difference from baseline in circulating brain-derived neurotrophic factor (BDNF) concentrations
Difference from baseline in circulating neuropeptide Y concentrations
Day 0
Difference from baseline in circulating cytokines concentrations.
Difference from baseline in circulating dehydroepiandrosterone-sulfate (DHEA-S) concentrations
Difference from baseline in salivary cortisol concentrations
Day 0
Difference from baseline in circulating S100 calcium binding protein B (S100B) concentrations
Hydrocortisone
Difference from baseline in circulating epinephrine concentrations
Difference from baseline in circulating intestinal fatty acid binding protein (I-FABP) concentrations.
Difference from baseline in circulating lipopolysaccharide concentrations
Difference from baseline in circulating norepinephrine concentrations
Difference from baseline in circulating zonulin concentrations
Day 0
Difference from baseline in mood state measured by the Profile of Mood States 2-A (POMS2A)
Day 0
Difference from baseline in perceived exertion
Day 0
Difference from baseline in distractibility to emotional stimuli
Difference from baseline in feelings of arousal
Difference from baseline in feelings of pleasantness
Difference from baseline in reaction time.
Difference from baseline in response inhibition
Difference from baseline in working memory
Day 29
Change from baseline in salivary secretory immunoglobulin A
Week 3
Difference from baseline in emotional states measured by the Depression, Anxiety and Stress Scale (DASS)
Difference from baseline in gastrointestinal discomfort
Difference from baseline in gastrointestinal symptoms
Difference from baseline in subjective ratings of fatigue
Day 29
Subjective pain ratings
Days 0 and 29
Change from baseline in aggression
Change from baseline in intestinal permeability
Change from baseline in performance on decision making under conditions of ambiguity task
Day 0
Change from baseline in exercise energy expenditure
Change from baseline in mean respiratory exchange ratio
Day 0
Change from baseline in mean heart rate
Day 0
Change from baseline in mean heart rate variability
Week 4
Difference from baseline in fecal abundance of probiotic bacteria
Difference from baseline in fecal acetate concentrations
Difference from baseline in fecal butyrate concentrations
Difference from baseline in fecal isobutyrate concentrations
Difference from baseline in fecal isovalerate concentrations
Difference from baseline in fecal metabolite levels
Difference from baseline in fecal propionate concentrations
Difference from baseline in fecal valerate concentrations
Difference from baseline in gut microbiota composition
Difference from baseline in gut microbiota gene content

Trial Safety

Trial Design

3 Treatment Groups

Probiotic
1 of 3
Prebiotic
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

54 Total Participants · 3 Treatment Groups

Primary Treatment: Probiotic · Has Placebo Group · N/A

Probiotic
DietarySupplement
Experimental Group · 1 Intervention: Probiotic · Intervention Types: DietarySupplement
Prebiotic
DietarySupplement
Experimental Group · 1 Intervention: Prebiotic · Intervention Types: DietarySupplement
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570
Prebiotic
2016
Completed Phase 2
~630

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: before (-45min) exercise, after 40 and 100 min of exercise, and immediately after exercise on days 0 and 29

Who is running the clinical trial?

United States Air Force Research LaboratoryUNKNOWN
United States Army Combat Capabilities Development Command Soldier CenterUNKNOWN
United States Army Research Institute of Environmental MedicineLead Sponsor
53 Previous Clinical Trials
3,271 Total Patients Enrolled
J. Philip Karl, PhD, RDPrincipal InvestigatorUnited States Army Research Institute of Environmental Medicine

Eligibility Criteria

Age 17 - 39 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are in good health as determined by Medical Clearance.
You are willing to follow the usual diet until provided diet phase of study.
If civilian, ≥4 d/wk aerobic and/or resistance exercise.