Healthy
Conditions
Keywords
athletes, probiotics, performance
Brief summary
Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance This study will intend: \- To assess the tolerability and the efficacy of a food supplements into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.
Detailed description
The present study aimed at assessing the tolerability and the efficacy of a food supplements probiotics-based (L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules) into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.
Interventions
DIETARY_SUPPLEMENTProbiotic capsule
probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules
DIETARY_SUPPLEMENTPlacebo
placebo consisted of the same capsules filled with potato starch
Sponsors
FitBiomics, Inc.
Giuliani S.p.A
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and Female athletes18-45 years old (included). 2. Subjects accepting to follow the instruction received by the investigator and disposable and able to return to the study centre at the established times. 3. Subjects accepting to not receive any drugs/cosmetics treatment able to interfere with the study results. 4. No participation in a similar study actually or during the previous 6 months. 5. Subjects accepting to sign the Informed consent form.
Exclusion criteria
* 1\. Known sensitivity to any compound of the Investigational product. 2. Pregnant or breast feeding females or planning a pregnancy. 3. Serious intercurrent infection or other active disease up to three months prior to study entry. 4\. History of concurrent malignancy. 5. History of significant alcohol or drug abuse. 6. Significant psycho-social or psychiatric disorders that may impair the subject's ability to meet the study requirements. 7\. Significant concurrent medical disorders that may impair the subject's ability to participate over the whole one year of the study. 8\. Any other medical condition which in the Investigator's opinion would prevent the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of physical parameters: soreness | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | Change of Soreness (measured by a 5-point scale) between T1 and T2 |
| Evaluation of physical parameters: fatigue | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | Change of Fatigue (measured by a 5-point scale) between T1 and T2 |
| Evaluation of physical parameters: energy | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | Change of Energy (measured by a 5-point scale) between T1 and T2between T1 and T2 |
| Evaluation of physical parameters:Sleep quality | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | Change of Sleep quality (evaluated by Sleep Quality Scale (SQS)) between T1 and T2between T1 and T2 |
| Evaluation of physical parameters:Digestive symptoms | at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE) | Change of the frequency of four individual digestive symptoms (abdominal pain/discomfort, bloating, flatulence/passage of gas and borborygmi/rumbling stomach) will be evaluated with five-point Likert scales that range from 0 (never) to 4 (every day of the week), between T1 and T2 |
| Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing | at baseline (T0) | 16S and metagenomic shotgun sequencing |
| Microbial dysbiosis ON URINE SAMPLES by mean of liquid chromatography- surface-activated chemical-ionization-electrospray ionization (LC/SASI-MS) and tandem mass spectrometry (MS/MS) | at baseline (T0), | By mean of liquid chromatography bacteria that potentially could cause dysbiosis by analyzing the profile of urine's metabolites and combining the results in the SANIST platform which predicts the intestinal dysbiosis based on the antagonist and pathogen bacteria pharmacological activity |
Countries
Italy
Outcome results
None listed