Probiotics and Overreaching Recovery

Immunosuppression Clinical Trial

Official title:

Probiotics for Athlete's Recovery and Immune System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04885010
• Other study ID #: PARIS
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: University of Padova
• Contact: Tatiana Moro, PhD
• Phone: 0498275306
• Email: tatiana.moro[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Fatigue; Muscle, Heart
• Immunosuppression

Intervention

Dietary Supplement:
• probiotics
participants will be given probiotics twice a day for 15 days
• placebo
participants will be given a placebo twice a day for 15 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lymphocyte subpopulation total T (CD3+)	lymphocyte subpopulation: total T (CD3+) %	Change from baseline to up to 15 days
Primary	T-helper (CD4+)	lymphocyte subpopulation: T-helper (CD4+) %	Change from baseline to up to 15 days
Primary	T-suppressor (CD8+)	lymphocyte subpopulation: T-suppressor (CD8+) %	Change from baseline to up to 15 days