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Clinical Trial Summary

The main objective of this research was to carry out an experimental study, triple blind, on the possible immunophysiological effects of a nutritional supplement (Synbiotic, Gasteel Plus®, Heel España S.A.U.), containing a mixture of probiotic strains, such as Bifidobacterium lactis CBP-001010, Lactobacillus rhamnosus CNCM I-4036, Bifidobacterium longum ES1, as well as prebi-otic fructooligosaccharides, in both professional athletes and sedentary people. The effects on some inflammatory/immune (IL-1β, IL-10, and immunoglobulin A) and stress (epinephrine, nore-pinephrine, dopamine, serotonin, CRH, ACTH, and cortisol) biomarkers were evaluated, determined by flow cytometer and ELISA. The effects on metabolic profile and physical activity, as well as on various parameters that could affect physical and mental health, were also evaluated via the use of accelerometry and validated questionnaires.


Clinical Trial Description

This investigation was a triple blinded, randomized, placebo-controlled pilot study designed to identify the possible differing effects of the synbiotic Gasteel Plus® supplementation. The participants were professional soccer players of the Second Division B of the Spanish League and sedentary students of the same sex and age range. Both study groups were randomly divided into two groups: a control group administered with placebo, and an experimental group administered with the synbiotic. Each participant was evaluated at baseline, as well as after the intervention which lasted one month. Only in the athletes group did the synbiotic intervention clearly improve objective physical activ-ity and sleep quality, as well as perceived general health, stress, and anxiety levels. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04776772
Study type Interventional
Source Catholic University of Murcia
Contact
Status Completed
Phase N/A
Start date May 15, 2019
Completion date June 30, 2019

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