Immune and Recovery Modulating Impact of Probiotic Supplementation After Intense Resistance Exercise
Condition: Immune Markers; Complete Blood Count (CBC) With Platelet Differentials; Muscle Damage; Muscular Force Production; Countermovement Jump; Muscular Fatigue; Muscular Soreness
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Active Probiotic Culture; Inactive Probiotic Culture
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Both conditions matched in appearance and serving size; Both conditions matched in appearance and serving size
Other intervention name(s): StaImune
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other