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
About this trial
This is an interventional treatment trial for Fatigue; Muscle, Heart
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)
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
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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Probiotics and Overreaching Recovery
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