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Health Parameters in Soccer Players and Sedentary Individuals After Consuming a Synbiotic

C

Catholic University of Murcia

Status

Completed

Conditions

Athlete
Sedentary Behavior

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Synbiotic complement

Study type

Interventional

Funder types

Other

Identifiers

NCT04776772
CE031810

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Sedentary individuals: students with low levels of physical activity (≤ 150 minutes/week),
  • Athletes: semi professional soccer players

Exclusion criteria

  • Participants were prohibited from consuming probiotics, prebiotics or fermented products (yogurt or other foods)
  • Presenting injury or illness

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

27 participants in 4 patient groups, including a placebo group

Soccer player placebo
Placebo Comparator group
Description:
Soccer player consuming placebo sticks filled with 300 mg excipient of maltodextrin
Treatment:
Dietary Supplement: Placebo
Soccer player synbiotic
Experimental group
Description:
Soccer players consuming a mixture of probiotic strains: Bifidobacterium lactis CBP-001010, Lactobacillus rhamno-sus CNCM I-4036, Bifidobacterium longum ES1 and fructooligosaccharides (200 mg) as a prebiotic
Treatment:
Dietary Supplement: Synbiotic complement
Sedentary individuals placebo
Placebo Comparator group
Description:
Sedentary individuals consuming placebo sticks filled with 300 mg excipient of maltodextrin
Treatment:
Dietary Supplement: Placebo
Sedentary individuals synbiotic
Experimental group
Description:
Sedentary individuals consuming a mixture of probiotic strains: Bifidobacterium lactis CBP-001010, Lactobacillus rhamno-sus CNCM I-4036, Bifidobacterium longum ES1 and fructooligosaccharides (200 mg) as a prebiotic
Treatment:
Dietary Supplement: Synbiotic complement

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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