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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04776772
Enrollment
27
Registered
2021-03-02
Start date
2019-05-15
Completion date
2019-06-30
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athlete, Sedentary Behavior

Keywords

anxiety, immunity, inflammation, prebiotic, probiotic, sedentarism, soccer, stress, synbiotic

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.

Interventions

DIETARY_SUPPLEMENTSynbiotic complement

On two separate days, the baseline-tests and final-tests were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the final-test and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic).

DIETARY_SUPPLEMENTPlacebo

On two separate days, the baseline-tests and final-tests were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the final-test and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (placebo).

Sponsors

Catholic University of Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometryDuring 7 days before the ingestion of the synbiotic or placeboParticipants wore the accelerometer held with an elastic band on the non-dominant wrist for 7 consecutive days and without interruption, except for those times of the day in which the correct operation of the device could be compromised (showers or any activity related to wa-ter). Subsequently, the files generated by the accelerometer were analyzed through a specific software called Actilife 6 (Actigraph, Pensacola, USA).
Questionnarie about general health.One day before the ingestion of the synbiotic or placeboSF-36 Questionnaire: Scale from 0 to 100. Higher scores mean a better outcome.
Questionnarie about anxiety levels (moment)One day before the ingestion of the synbiotic or placeboThe State Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.
Questionnarie about anxiety levels (personality)One day before the ingestion of the synbiotic or placeboThe Trait Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.
Questionnarie about sleep qualityOne day before the ingestion of the synbiotic or placeboHealthy Lifestyle and Personal Control Questionnaire: Scale from -1 to 10. Higher scores mean a better outcome.
Questionnarie about perceived stressOne day before the ingestion of the synbiotic or placeboThe Perceived Stress Scale: Scale from 0 to 56. Higher scores mean a worse outcome.
Questionnarie about perceived fatigueOne day before the ingestion of the synbiotic or placeboBrief Fatigue Inventory: Scale from 0 to 40. Higher scores mean a worse outcome.
Questionnarie about perceived depressionOne day before the ingestion of the synbiotic or placeboBeck´s Depression Inventory: Scale from 0 to 63. Higher scores mean a worse outcome.
Determination of the pro-inflammatory cytokine IL-1β (Blood sampling)One day before the ingestion of the synbiotic or placeboUsing the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis. Measured in pg/ml.
Determination of the anti-inflammatory cytokine IL-10 (Blood sampling)One day before the ingestion of the synbiotic or placeboUsing the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis. Measured in pg/ml.
Determination of the stress hormones Cortisol (Blood sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by competitive inhibition enzyme immunoassays (ELISA), using The DetectX Cortisol Immunoassay Kit. Measured in µg/dl.
Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human ACTH (Adrenocorticotropic Hormone) ELISA Kit (Elabscience, USA). Measured in pg/ml.
Determination of the corticotropin-releasing hormone (CRH) (Blood sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human Corticotropin Releasing Hormone (CRH) RD-CRH-Hu (Kelowna, BC, V1W 4V3, Canada) Measured in pg/ml.
Determination of the stress hormones serotonin (Blood sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by competitive inhibition enzyme immunoassays (ELISA), using The General 5-Hydroxytryptamine (5-HT) RD-5-HT-Ge. Measured in ng/ml.
Determination of the catecholamine dopamine (Blood sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by competitive inhibition enzyme immunoassays (ELISA), using The Dopamine Research Immunoassay Measured in ng/ml.
Determination of the catecholamine epinephrine (Blood sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Epinephrine (EPI) RD-EPI-Ge-96T. Measured in pg/ml.
Determination of the catecholamine norepinephrine (Blood sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Noradrenaline (NE) RD-NE-Ge-96T. Measured in pg/ml.
Determination of the immunoglobulin A (Saliva sampling)One day before the ingestion of the synbiotic or placeboAnalyzed by indirect enzyme immunoassay kit through the Salivary Secretory IgA Kit (Salimetrics LLC, USA). The procedures followed the instructions of the manufacturers, and the findings were measured using an ELISA auto analyzer to quantify color intensity (Sunrise, Tecan, Männendorf, Switzerland). Measured in µg/ml
Determination of glucose levels (metabolic profile)One day before the ingestion of the synbiotic or placeboThe determinations for obtaining the glycemic profile were carried out through standard techniques with the automatic analyzer of clinical chemistry BA 400 (BioSystems) in the SYNLAB laboratories (Diagnosticos Globales S.A.U., Badajoz, Spain). Measured in mg/dl
Determination of total cholesterol levels (metabolic profile)One day before the ingestion of the synbiotic or placeboThe determinations for obtaining the lipid profile were carried out through standard techniques with the automatic analyzer of clinical chemistry BA 400 (BioSystems) in the SYNLAB laboratories (Diagnosticos Globales S.A.U., Badajoz, Spain). Measured in mg/dl
Determination of the triglycerides levels (metabolic profile)One day before the ingestion of the synbiotic or placeboThe determinations for obtaining the lipid profile were carried out through standard techniques with the automatic analyzer of clinical chemistry BA 400 (BioSystems) in the SYNLAB laboratories (Diagnosticos Globales S.A.U., Badajoz, Spain). Measured in mg/dl

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026