Efficacy of a Mix of Probiotics in Athletes Performance

NCT06093139 | Completed

• 1 other identifier: GIU-PPA-0420
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

athletes; probiotics; performance

Outcome Measures

Primary Outcomes (11)

• Evaluation of physical parameters: soreness

  Change of Soreness (measured by a 5-point scale) between T1 and T2

  at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

• Evaluation of physical parameters: fatigue

  Change of Fatigue (measured by a 5-point scale) between T1 and T2

  at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

• Evaluation of physical parameters: energy

  Change of Energy (measured by a 5-point scale) between T1 and T2between T1 and T2

  at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

• Evaluation of physical parameters:Sleep quality

  Change of Sleep quality (evaluated by Sleep Quality Scale (SQS)) between T1 and T2between T1 and T2

  at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

• Evaluation of physical parameters:Digestive symptoms

  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

  at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)

• Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing

  16S and metagenomic shotgun sequencing

  at baseline (T0)

• Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing

  16S and metagenomic shotgun sequencing

  at T1 (12 weeks with placebo) a

• Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing

  16S and metagenomic shotgun sequencing

  at T1 (12 week with ACTIVE)

• 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)

  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

  at baseline (T0),

• 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)

  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

  at T1 (12 weeks with placebo)

• 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)

  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

  T1 (12 week with ACTIVE)

Study Arms (2)

Active

ACTIVE COMPARATOR

Probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules alongside additional potato starch as a filler).

Dietary Supplement: Probiotic capsule

Placebo

PLACEBO COMPARATOR

Placebo capsule (placebo consisted of the same capsules filled with potato starch)

Dietary Supplement: Placebo

Interventions

Probiotic capsule DIETARY_SUPPLEMENT

probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules

Also known as: L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules

Active

Placebo DIETARY_SUPPLEMENT

placebo consisted of the same capsules filled with potato starch

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Female athletes18-45 years old (included).
• Subjects accepting to follow the instruction received by the investigator and disposable and able to return to the study centre at the established times.
• Subjects accepting to not receive any drugs/cosmetics treatment able to interfere with the study results.
• No participation in a similar study actually or during the previous 6 months.
• Subjects accepting to sign the Informed consent form.

You may not qualify if:

• \. 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.
• \. 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.
• \. Significant concurrent medical disorders that may impair the subject's ability to participate over the whole one year of the study.
• \. Any other medical condition which in the Investigator's opinion would prevent the subject from participating in the study.

Sponsors & Collaborators

• Giuliani S.p.A: lead
• FitBiomics, Inc.: collaborator

Study Sites (1)

Centro Sportivo Parma Football

Collecchio, Parma, 43044, Italy

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• DANIELA PINTO

  Giuliani S.p.A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: October 23, 2023
• Study Start: November 29, 2021
• Primary Completion: September 20, 2022
• Study Completion: October 5, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)