Probiotics and Overreaching Recovery

May 7, 2021 updated by: University of Padova

Probiotics for Athlete's Recovery and Immune System

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics
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.
Dietary supplement: probiotics
participants will be given probiotics twice a day for 15 days
Placebo Comparator: Placebo
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.
Dietary supplement: placebo
participants will be given a placebo twice a day for 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymphocyte subpopulation total T (CD3+)
Time Frame: Change from baseline to up to 15 days
lymphocyte subpopulation: total T (CD3+) %
Change from baseline to up to 15 days
T-helper (CD4+)
Time Frame: Change from baseline to up to 15 days
lymphocyte subpopulation: T-helper (CD4+) %
Change from baseline to up to 15 days
T-suppressor (CD8+)
Time Frame: Change from baseline to up to 15 days
lymphocyte subpopulation: T-suppressor (CD8+) %
Change from baseline to up to 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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