Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise

Study Overview
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Brief Summary
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This study proposal seeks to examine the efficacy of probiotic supplementation at mitigating changes in immune function and recovery after completion of intense, stressful exercise while also allowing for a better understanding of its ability to promote recovery and maintenance of physical performance.

Detailed Description
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Study Visit 1 - Familiarization: During the familiarization visit, participants will first read and sign an IRB-approved informed consent document and complete a short form of the International Physical Activity Questionnaire (IPAQ). Participants will then have their height, weight, and body composition determined using Dual-Energy X-ray Absorptiometry (DEXA) (Hologic Discovery A). To standardize body composition assessment, participants will be required to observe an 8-hour fast and maintain a well-hydrated state. Each participant will provide a urine sample to confirm a hydrated stated through determination of a urine specific gravity values greater 1.020. Participants will then complete a peak oxygen consumption test (VO2Peak) using indirect calorimetry on a ParvoMedics TrueOne (Sandy, UT) metabolic cart interfaced to a motorized cycle ergometer (Lode Corival). The peak oxygen consumption test protocol will require each study participants to start at 100 watts before progressively increasing by 1 watt every two seconds. To determine whether maximal effort occurred a respiratory exchange ratio of >1.00 must be achieved. Following the peak oxygen consumption assessment, participants will perform practice repetitions of all performance tests (force plate vertical jumps, isometric mid-thigh pulls, Biodex isometric and isokinetic knee extensor testing) as well as the exercises that will be performed during Visit 3 (leg press, hex bar deadlift, and drop jump). Study Visit 2 - Pre-Supplementation Baseline Testing: Study participants will be asked to complete a 24-hour food recall between each testing condition and will be asked to replicate their diet prior to this visit for all subsequent visits. Upon arrival, participants will first have their blood drawn from a forearm vein before completing a perceived soreness, pressure-pain threshold, and recovery assessment. Prior to testing, participants will complete the same standardized warm-up consisting of 5 minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the warm-up, participants will complete five countermovement jump squats on top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant force-time variables. Next, participants will complete two assessments of peak isometric force production. Using an electronic load cell with a 5,000-N capacity (Load Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be completed. Participants will then be outfitted on a Biodex isokinetic dynamometer where they will complete three maximal isometric knee extensions. Following the isometric knee extensor testing, participants will complete a 50-repetition test of concentric-only repetitions to assess changes in force production, torque, and rates of fatigue development. After the baseline performance testing, participants will have their leg press and hex bar deadlift one-repetition maximum (1RM) determined. *Supplementation (14 days, described below) followed by exercise trial.* Study Visit 3 (Post-Supplementation Testing, Exercise Trial): Upon arrival, study participants will be asked to complete a 24-hour food recall and between each testing condition, study participants will be asked to replicate their diet. Upon arrival, participants will first have their blood drawn from a forearm vein before completing perceived soreness, pressure-pain threshold, and recovery assessments. Prior to testing, participants will complete the same standardized warm-up consisting of 5 minutes of light cycling, 10 body weight squats, 10 body weight walking lunges, 10 dynamic walking hamstring stretches (straight-leg march), and 10 dynamic walking quadriceps stretches. After the warm-up, participants will complete five countermovement jump squats on top of bilateral triaxial force plates (Hawkins Dynamics) interfaced to a personal computer to derive relevant force-time variables. Using an electronic load cell with a 5,000-N capacity (Load Star load cells) connected to a computer, three 5-second maximal isometric mid-thigh pulls will be completed. Participants will then be positioned on a Biodex isokinetic dynamometer where they will complete three maximal isometric knee extensions. Lastly, participants will complete a 50-repetition test of concentric-only repetitions to assess changes in force production, torque, and rates of fatigue development. Following the completion of these tests, participants will perform an exercise trial according to the methods described below. Following completion of the exercise trial, participants will undergo the previous testing battery (blood sample, perceived soreness, pressure-pain threshold assessment, recovery assessment, countermovement vertical jumps, isometric mid-thigh pulls, Biodex isometric and isokinetic testing) at five time points: immediately after exercise, 30 minutes post-exercise, 1 hour, 2 hours, and 5 hours post-exercise. Study Visits 4 - 6: Post-Exercise Performance In an identical fashion, with the exception of 1RM assessment, study visits 4, 5, and 6 will be completed 24, 48, and 72 hours, respectively, after completion of the exercise bout. Briefly, study participants will return to the laboratory after an overnight fast (10 hours). Participants will bring in the completed 24-hour dietary recall, donate venous blood samples, assess their soreness, pressure-pain threshold, and recovery, complete the warm-up, perform five countermovement jumps, assess peak isometric force production, and complete a 50-repetition muscle fatigue test during each visit.

Official Title
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Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise

Conditions
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Immune Markers, Complete Blood Count (CBC) With Platelet Differentials, Muscle Damage, Muscular Force Production, Countermovement Jump, Muscular Fatigue, Muscular Soreness

Intervention / Treatment
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* Dietary Supplement: Active Probiotic Culture
* Dietary Supplement: Inactive Probiotic Culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Free from any disorders or diseases as stated on health history form Between the ages of 18 - 55 years of age Exclusion Criteria: Currently being treated for or are diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2 and body fat greater than 30%), immune, autoimmune, hematological, neurological or endocrinological disorder or disease unless the scenario is viewed to not be a contraindication by the clinical coordinator of the study protocol. Individuals who are currently prescribed a hypertensive or cholesterol-lowering medication will be allowed entry into the study with clearance from clinical coordinator or their personal physician. Female An individual who is less than 18 and greater than 55 years of age will be excluded. Participants younger than 18 are excluded due to necessity of parental consent. Participants greater than 55 years old lie outside of the target demographic for the current study. Considered to be sedentary, defined as getting less than 30 minutes of moderate intensity physical activity for most days of the week. Currently not resistance training at least 2 days per week for the past 30 days Currently smoking or have quit smoking within the past 6 months Currently taking a probiotic. Individuals who currently report as taking a probiotic will be allowed entry into study protocol if a wash-out period of 30 days is observed.) Currently consuming any form of dietary supplements that are viewed by study investigators to confound the outcomes of the study protocol (i.e., creatine, beta-alanine, essential amino acids, beta-hydroxy-beta-methylbutyrate (HMB), branched-chain amino acids, or any pre-workout that contain combinations of these ingredients). Individuals who currently report as taking any of these supplements will be allowed entry into study protocol if a wash-out period of 30 days is observed.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Probiotic Culture<br>Active culture of Bacillus Coagulans Dose: 1 x 10^9 colony forming units (CFU) | Dietary Supplement: Active Probiotic Culture<br>* Both conditions matched in appearance and serving size<br>|
| Active Comparator: Inactive Probiotic Culture<br>Inactive culture of Bacillus Coagulans (GBI-30, 6086) - Marked as StaImune Dose: 1 x 10^9 colony forming units (CFU) | Dietary Supplement: Inactive Probiotic Culture<br>* Both conditions matched in appearance and serving size<br>* Other names: StaImune;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Markers | C-reactive protein [milligrams per liter (mg/L)] | Three weeks | 
| Complete blood count | White blood cell and platelet count [Thousand per microliter (Thousand/uL)] | Three weeks | 
| Markers of muscle damage | Creatine kinase [Units per liter (U/L)] | Three weeks | 
| Force production assessment | Maximal voluntary isometric contraction (knee extension) [pounds (lb)] | Three weeks | 
| Force production assessment | Isometric mid-thigh pull [pounds (lb)] | Three weeks | 
| Countermovement Jump | peak force [Newtons (N)] | Three weeks | 
| Countermovement Jump | eccentric force [Newtons (N)] | Three weeks | 
| Countermovement Jump | eccentric rate of force development [Newtons (N)] | Three weeks | 
| Countermovement Jump | reactive strength index | Three weeks | 
| Dynamic muscular fatigue | Biodex 50-repetition test [Percent fatigue rate] | Three weeks | 
| Perceived soreness | Soreness questionnaire (0 - 10) 0 is low, 10 is high | Three weeks | 
| Perceived soreness | pain-pressure threshold via algometer [Newtons (N)] | Three weeks | 
| Immune Marker | Interleukin-6, Tumor necrosis factor-alpha, Monocyte chemoattractant protein 1 [picograms per milliliter (pg/mL)] | Three weeks | 
| Markers of muscle damage | Myoglobin [nanogram per milliliter (ng/mL)]. | Three weeks | 
| Complete blood count (CBC) | Red blood cell count [Millions per microliter (million/uL)] | Three weeks | 
| Complete blood count (CBC) | Hemoglobin and Mean corpuscular hemoglobin concentration (MCHC) [grams per deciliter (g/dL)] | Three weeks | 
| Complete blood count (CBC) | Hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils,Red cell distribution width (RDW) [Percentage (%)] | Three weeks | 
| Complete blood count (CBC) | Mean corpuscular volume (MCV) and Mean platelet volume (MPV) [Femtoliters (fL)] | Three weeks | 
| Complete blood count (CBC) | Mean corpuscular hemoglobin (MCH) [Picograms (pg)] | Three weeks | 
| Complete blood count (CBC) | Absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils [cells per microliter (cells/uL)] | Three weeks |