Effect of a Short-term Multi-strain Probiotic Supplementation in Endurance Athletes
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age16-50
SponsorKrzysztof Durkalec-Michalski
About this trial
The aim of this project is to evaluate and identify the effect of a short-term 2-week multi-strain probiotic (MPRO) supplementation on the exercise-associated gastrointestinal (GI) symptoms and perturbations in high level female athletes of the Polish national team during strictly controlled conditions of a training camp, based on recommendations for best practices for probiotic (PRO) research in athletes and assessment of EX-associated GI perturbations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
belonging to the national rowing team;
training experience ≥5 years;
a currently issued medical certificate confirming
good health and capacity to practice sports;
Disqualifiers
injury, any health contraindication or failure to perform exercise procedures;
gastrointestinal infections, diseases, disorders;
past history of gastrointestinal surgery, and
other self-reported gastrointestinal issues;
Trial design
Design model
Crossover
Treatments tested in this trial
MPRO supplementation
Dietary supplementIn the experimental procedure each athlete will be supplemented with a certificated, commercially available MPRO supplement SANPROBI® Barrier (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24). The supplement will be provided in the capsule form and will be taken twice a day \[4 capsules of MPRO/day (2×10to9 CFU/g, 500 milions CFU/capsule) in two servings/day (2x2 capsules\].
Placebo treatment
Dietary supplementIn the control procedure each athlete will be supplemented with a placebo (PLA). The PLA group will receive corn starch mixed with maltodextrins. The PLA will be provided in the capsule form and will be taken twice a day (2x2 capsules/day).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: MPRO supplementationExperimental treatment 1 intervention
Group B: PLA treatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in gastrointestinal integrity and inflammation markers (I-FABP, claudin-3, zonulin, LPS, scd-14, LBP, ocludin, lipocalin-2, DAO) (ng/mL) in blood after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (I-FABP, claudin-3, zonulin, LPS, scd-14, LBP, ocludin, lipocalin-2, DAO) (ng/mL) in blood at three time-points (resting \[REST\]; 3 min \[POST-EX\] and 60 min after completion of the test exercise \[REC\]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.2
Changes in gastrointestinal integrity and inflammation markers (zonulin, ocludin, lipocalin-2) (ng/mL) in stool after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (zonulin, ocludin, lipocalin-2) (ng/mL) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.3
Changes in gastrointestinal integrity and inflammation markers (calprotectin, lactoferrin) (μg/g) in stool after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (calprotectin, lactoferrin) (μg/g) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.4
Changes in gastrointestinal integrity and inflammation markers (α-1 antitripsin) (mg/g) in stool after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal integrity markers (α-1 antitripsin) (mg/g) in stool at rest will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.Secondary outcomes
1
Changes in blood cytokines (IL-1β/1ra/6/8/10/17, TNF-α) (pg/mL) after MPRO supplementation and PLA treatment
Assessment of the cytokines (IL-1β/1ra/6/8/10/17, TNF-α) (pg/mL) at three time-points (resting \[REST\]; 3 min \[POST-EX\] and 60 min after completion of the second test exercise \[REC\]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.2
Changes in stress marker (cortisol) (ng/ml) in blood and saliva after MPRO supplementation and PLA treatment
Assessment of the stress marker (cortisol) (ng/ml) in blood and saliva at three time-points (resting \[REST\]; 3 min \[POST-EX\] and 60 min after completion of the test exercise \[REC\]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.3
Changes in saliva SIgA concentration (μg/mL) after MPRO supplementation and PLA treatment
Assessment of the saliva SIgA concentration (μg/mL) at three time-points (resting \[REST\]; 3 min \[POST-EX\] and 60 min after completion of the test exercise \[REC\]) will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.4
Changes in gastrointestinal symptoms incidence and severity (points) after MPRO supplementation and PLA treatment
Assessment of the gastrointestinal symptoms incidence and severity (points) will be carried out before, during and after aerobic fitness and exercise performance test at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.Other outcomes
1
Changes in the aerobic fitness and exercise performance test results (aerobic capacity measured by maximum workload at exhaustion in Watts) after MPRO supplementation and PLA treatment IRT performance
Assessment of the aerobic capacity (Watts) will be carried out by the increasing intensity ramp exercise test on a rowing ergometer at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.2
Changes in the aerobic fitness and exercise performance test results (aerobic capacity measured by maximal oxygen uptake in mL/min/kg) after MPRO supplementation and PLA treatment IRT performance
Assessment of the aerobic capacity (maximal oxygen uptake in mL/min/kg) will be carried out by the increasing intensity ramp exercise test on a rowing ergometer at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.3
Changes in heart rate (bpm) during aerobic fitness and exercise performance test after MPRO supplementation and PLA treatment
Assessment of the heart rate (bpm) during the increasing intensity ramp exercise test on a rowing ergometer will be carried out at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.4
Changes in lactate concentration (mmol/L) before, during and after aerobic fitness and exercise performance test after MPRO supplementation and PLA treatment
Assessment of the lactate concentration (mmol/L) will be performed from fingertip capillary blood before, during and 3-min after the increasing intensity ramp exercise test on a rowing ergometer at four main visits to the laboratory (T1-T4; before/after supplementation with MPRO and PLA).
Time frame
Baseline (before MPRO supplementation) and after 2 weeks of MPRO supplementation; baseline (before PLA supplementation) and after 2 weeks of PLA supplementation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Krzysztof Durkalec-Michalski
Lead sponsor
Poznan University of Physical Education
Sponsor institution
Institute of Human Genetics, Polish Academy of Sciences
Collaborator
Source ClinicalTrials.gov