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Probiotics and Overreaching Recovery

Primary Purpose

Fatigue; Muscle, Heart, Immunosuppression

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
probiotics
placebo
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue; Muscle, Heart

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 25-55 years
  • Body mass index:> 18 and <30 kg / m2
  • Stable body weight for at least 3 months
  • regular practice of physical activity for at least 2 years

Exclusion Criteria:

  • Chronic diseases (cardiovascular, hepatic, respiratory, cancer)
  • Acute inflammatory states, infections or other pathologies
  • Regular use of probiotics
  • Use or treatment with steroids (within the previous 3 months)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotics

    Placebo

    Arm Description

    participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching.

    participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching.

    Outcomes

    Primary Outcome Measures

    lymphocyte subpopulation total T (CD3+)
    lymphocyte subpopulation: total T (CD3+) %
    T-helper (CD4+)
    lymphocyte subpopulation: T-helper (CD4+) %
    T-suppressor (CD8+)
    lymphocyte subpopulation: T-suppressor (CD8+) %

    Secondary Outcome Measures

    Full Information

    First Posted
    May 7, 2021
    Last Updated
    May 7, 2021
    Sponsor
    University of Padova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04885010
    Brief Title
    Probiotics and Overreaching Recovery
    Official Title
    Probiotics for Athlete's Recovery and Immune System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    September 30, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Padova

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Overloading is a key training principle used by athletes and coaches to improve physical performance. Intensified training periods are therefore commonly incorporated into the course of a regular training season. From a clinical point of view, very intense periods of training are associated with a temporary immunological deficiency which can lead to teh "overreaching syndroms". During periods of overreaching, nutritional strategies are mainly aimed at ensuring sufficient amounts of energy to support the increase in effort. However less is known about nutritional supplements to attenuated the inflammatory/immunological response to training stress. Probiotic bacteria are defined as live food ingredients beneficial to the host's health. Numerous health benefits have been attributed to probiotics, including effects on gastrointestinal tract function and disease, immune function, hyperlipidemia, hypertension, and allergic conditions. Studies in the literature on the ergogenic effect of probiotics in athletes are still scarce today. this study aims to explore the potential role of probiotics on performance, recovery from fatigue and immune function during intensive period of training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue; Muscle, Heart, Immunosuppression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotics
    Arm Type
    Experimental
    Arm Description
    participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    probiotics
    Intervention Description
    participants will be given probiotics twice a day for 15 days
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    participants will be given a placebo twice a day for 15 days
    Primary Outcome Measure Information:
    Title
    lymphocyte subpopulation total T (CD3+)
    Description
    lymphocyte subpopulation: total T (CD3+) %
    Time Frame
    Change from baseline to up to 15 days
    Title
    T-helper (CD4+)
    Description
    lymphocyte subpopulation: T-helper (CD4+) %
    Time Frame
    Change from baseline to up to 15 days
    Title
    T-suppressor (CD8+)
    Description
    lymphocyte subpopulation: T-suppressor (CD8+) %
    Time Frame
    Change from baseline to up to 15 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age 25-55 years Body mass index:> 18 and <30 kg / m2 Stable body weight for at least 3 months regular practice of physical activity for at least 2 years Exclusion Criteria: Chronic diseases (cardiovascular, hepatic, respiratory, cancer) Acute inflammatory states, infections or other pathologies Regular use of probiotics Use or treatment with steroids (within the previous 3 months)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tatiana Moro, PhD
    Phone
    0498275306
    Email
    tatiana.moro@unipd.it

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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