Clinical trial NCT04776772: Health Parameters in Soccer Players and Sedentary Individuals After Consuming a Synbiotic
Official title: Differential Health Effects on Inflammatory, Immunological and Stress Parameters in Professional Soccer Players and Sed-entary Individuals After Consuming a Synbiotic. A Triple Blind-ed, Randomized, Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athlete
Sedentary Behavior
Keywords: anxiety
immunity
inflammation
prebiotic
probiotic
sedentarism
soccer
stress
synbiotic
Lead sponsor: Catholic University of Murcia
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry
timeFrame: During 7 days before the ingestion of the synbiotic or placebo
measure: Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry
timeFrame: During 7 days after the ingestion of the synbiotic or placebo
measure: Questionnarie about general health.
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Questionnarie about general health.
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Questionnarie about anxiety levels (moment)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Questionnarie about anxiety levels (moment)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Questionnarie about anxiety levels (personality)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Questionnarie about anxiety levels (personality)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Questionnarie about sleep quality
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Questionnarie about sleep quality
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Questionnarie about perceived stress
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Questionnarie about perceived stress
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Questionnarie about perceived fatigue
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Questionnarie about perceived fatigue
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Questionnarie about perceived depression
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Questionnarie about perceived depression
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the pro-inflammatory cytokine IL-1β (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the pro-inflammatory cytokine IL-1β (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the anti-inflammatory cytokine IL-10 (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the anti-inflammatory cytokine IL-10 (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the stress hormones Cortisol (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the stress hormones Cortisol (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the corticotropin-releasing hormone (CRH) (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the corticotropin-releasing hormone (CRH) (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the stress hormones serotonin (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the stress hormones serotonin (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the catecholamine dopamine (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the catecholamine dopamine (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the catecholamine epinephrine (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the catecholamine epinephrine (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the catecholamine norepinephrine (Blood sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the catecholamine norepinephrine (Blood sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the immunoglobulin A (Saliva sampling)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the immunoglobulin A (Saliva sampling)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of glucose levels (metabolic profile)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of glucose levels (metabolic profile)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of total cholesterol levels (metabolic profile)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of total cholesterol levels (metabolic profile)
timeFrame: One day after the ingestion of the synbiotic or placebo
measure: Determination of the triglycerides levels (metabolic profile)
timeFrame: One day before the ingestion of the synbiotic or placebo
measure: Determination of the triglycerides levels (metabolic profile)
timeFrame: One day after the ingestion of the synbiotic or placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Carmen Quero, PhD
role: PRINCIPAL_INVESTIGATOR
References: