Probiotics and Overreaching Recovery

NCT04885010 | Unknown

• 1 other identifier: PARIS
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fatigue; Muscle, Heart; Immunosuppression

Outcome Measures

Primary Outcomes (3)

• lymphocyte subpopulation total T (CD3+)

  lymphocyte subpopulation: total T (CD3+) %

  Change from baseline to up to 15 days

• T-helper (CD4+)

  lymphocyte subpopulation: T-helper (CD4+) %

  Change from baseline to up to 15 days

• T-suppressor (CD8+)

  lymphocyte subpopulation: T-suppressor (CD8+) %

  Change from baseline to up to 15 days

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

probiotics DIETARY_SUPPLEMENT

participants will be given probiotics twice a day for 15 days

Probiotics

placebo DIETARY_SUPPLEMENT

participants will be given a placebo twice a day for 15 days

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Padova: lead

MeSH Terms

Conditions

Fatigue

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Tatiana Moro, PhD

CONTACT

0498275306; tatiana.moro@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: June 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share