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

NCT04441840 | Completed

• 1 other identifier: IRB-19-161
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (2)

Active Probiotic Culture

ACTIVE COMPARATOR

Active culture of Bacillus Coagulans Dose: 1 x 10\^9 colony forming units (CFU)

Dietary Supplement: Active Probiotic Culture

Inactive Probiotic Culture

ACTIVE COMPARATOR

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

Interventions

Active Probiotic Culture DIETARY_SUPPLEMENT

Both conditions matched in appearance and serving size

Active Probiotic Culture

Inactive Probiotic Culture DIETARY_SUPPLEMENT

Both conditions matched in appearance and serving size

Also known as: StaImune

Inactive Probiotic Culture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Free from any disorders or diseases as stated on health history form
• Between the ages of 18 - 55 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

Location

Study Officials

• Chad Kerksick, PhD

  Laboratory Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The supplements were delivered in identical containers, each marked with a separate code marked on the outside of the supplement container. Once data collection, data entry, and statistical analysis was completely finished, the study code was broken.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 22, 2020
• Study Start: April 16, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)