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Immune MarkersNCT04441840

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

A study testing Active Probiotic Culture and Inactive Probiotic Culture in people with Immune Markers and Complete Blood Count (CBC) With Platelet Differentials, run by Lindenwood University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
What is being tested?
Active Probiotic Culture and Inactive Probiotic Culture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
16 Apr 2019to 1 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Lindenwood University

    Saint Charles, Missouri, 63301

Other trials in United States

About this study

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.

Read the 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.

Being tested
Active Probiotic Culture, Inactive Probiotic Culture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Probiotic CultureDietary supplement

    Both conditions matched in appearance and serving size

  • Inactive Probiotic CultureDietary supplement

    Also called StaImune

    Both conditions matched in appearance and serving size

Study groups in NCT04441840
Study groupRoleWhat they receive
Active Probiotic CultureActive comparatorActive culture of Bacillus Coagulans Dose: 1 x 10^9 colony forming units (CFU)
Receives: Dietary Supplement: Active Probiotic Culture
Inactive Probiotic CultureActive comparatorInactive culture of Bacillus Coagulans (GBI-30, 6086) - Marked as "StaImune" Dose: 1 x 10^9 colony forming units (CFU)
Receives: Dietary Supplement: Inactive Probiotic Culture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune Markers

    C-reactive protein [milligrams per liter (mg/L)]

    Measured: Three weeks

  2. Complete blood count

    White blood cell and platelet count [Thousand per microliter (Thousand/uL)]

    Measured: Three weeks

  3. Markers of muscle damage

    Creatine kinase [Units per liter (U/L)]

    Measured: Three weeks

  4. Force production assessment

    Maximal voluntary isometric contraction (knee extension) [pounds (lb)]

    Measured: Three weeks

  5. Force production assessment

    Isometric mid-thigh pull [pounds (lb)]

    Measured: Three weeks

  6. Countermovement Jump

    peak force [Newtons (N)]

    Measured: Three weeks

  7. Countermovement Jump

    eccentric force [Newtons (N)]

    Measured: Three weeks

  8. Countermovement Jump

    eccentric rate of force development [Newtons (N)]

    Measured: Three weeks

  9. Countermovement Jump

    reactive strength index

    Measured: Three weeks

  10. Dynamic muscular fatigue

    Biodex 50-repetition test [Percent fatigue rate]

    Measured: Three weeks

  11. Perceived soreness

    Soreness questionnaire (0 - 10) 0 is low, 10 is high

    Measured: Three weeks

  12. Perceived soreness

    pain-pressure threshold via algometer [Newtons (N)]

    Measured: Three weeks

  13. Immune Marker

    Interleukin-6, Tumor necrosis factor-alpha, Monocyte chemoattractant protein 1 [picograms per milliliter (pg/mL)]

    Measured: Three weeks

  14. Markers of muscle damage

    Myoglobin [nanogram per milliliter (ng/mL)].

    Measured: Three weeks

  15. Complete blood count (CBC)

    Red blood cell count [Millions per microliter (million/uL)]

    Measured: Three weeks

  16. Complete blood count (CBC)

    Hemoglobin and Mean corpuscular hemoglobin concentration (MCHC) [grams per deciliter (g/dL)]

    Measured: Three weeks

  17. Complete blood count (CBC)

    Hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils,Red cell distribution width (RDW) [Percentage (%)]

    Measured: Three weeks

  18. Complete blood count (CBC)

    Mean corpuscular volume (MCV) and Mean platelet volume (MPV) [Femtoliters (fL)]

    Measured: Three weeks

  19. Complete blood count (CBC)

    Mean corpuscular hemoglobin (MCH) [Picograms (pg)]

    Measured: Three weeks

  20. Complete blood count (CBC)

    Absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils [cells per microliter (cells/uL)]

    Measured: Three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2020
  2. Study start16 Apr 2019
  3. Primary completion1 Aug 2021
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04441840
Sponsor's protocol ID
IRB-19-161
Status last verified
Apr 2022
First submitted
12 Jun 2020
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain Institutional Review Board (IRB) compliance

Questions about this trial

What is this clinical trial studying?

A study testing Active Probiotic Culture and Inactive Probiotic Culture in people with Immune Markers and Complete Blood Count (CBC) With Platelet Differentials, run by Lindenwood University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune Markers (time frame: Three weeks). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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