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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Athlete, Sedentary Behavior

Intervention / Treatment
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* Dietary Supplement: Synbiotic complement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Soccer player placebo<br>Soccer player consuming placebo sticks filled with 300 mg excipient of maltodextrin | Dietary Supplement: Placebo<br>* 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).<br>|
| Experimental: Soccer player synbiotic<br>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 | Dietary Supplement: Synbiotic complement<br>* 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).<br>|
| Placebo Comparator: Sedentary individuals placebo<br>Sedentary individuals consuming placebo sticks filled with 300 mg excipient of maltodextrin | Dietary Supplement: Placebo<br>* 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).<br>|
| Experimental: Sedentary individuals synbiotic<br>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 | Dietary Supplement: Synbiotic complement<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry | Participants 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). | During 7 days before the ingestion of the synbiotic or placebo | 
| Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry | Participants 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). | During 7 days after the ingestion of the synbiotic or placebo | 
| Questionnarie about general health. | SF-36 Questionnaire: Scale from 0 to 100. Higher scores mean a better outcome. | One day before the ingestion of the synbiotic or placebo | 
| Questionnarie about general health. | SF-36 Questionnaire: Scale from 0 to 100. Higher scores mean a better outcome. | One day after the ingestion of the synbiotic or placebo | 
| Questionnarie about anxiety levels (moment) | The State Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome. | One day before the ingestion of the synbiotic or placebo | 
| Questionnarie about anxiety levels (moment) | The State Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome. | One day after the ingestion of the synbiotic or placebo | 
| Questionnarie about anxiety levels (personality) | The Trait Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome. | One day before the ingestion of the synbiotic or placebo | 
| Questionnarie about anxiety levels (personality) | The Trait Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome. | One day after the ingestion of the synbiotic or placebo | 
| Questionnarie about sleep quality | Healthy Lifestyle and Personal Control Questionnaire: Scale from -1 to 10. Higher scores mean a better outcome. | One day before the ingestion of the synbiotic or placebo | 
| Questionnarie about sleep quality | Healthy Lifestyle and Personal Control Questionnaire: Scale from -1 to 10. Higher scores mean a better outcome. | One day after the ingestion of the synbiotic or placebo | 
| Questionnarie about perceived stress | The Perceived Stress Scale: Scale from 0 to 56. Higher scores mean a worse outcome. | One day before the ingestion of the synbiotic or placebo | 
| Questionnarie about perceived stress | The Perceived Stress Scale: Scale from 0 to 56. Higher scores mean a worse outcome. | One day after the ingestion of the synbiotic or placebo | 
| Questionnarie about perceived fatigue | Brief Fatigue Inventory: Scale from 0 to 40. Higher scores mean a worse outcome. | One day before the ingestion of the synbiotic or placebo | 
| Questionnarie about perceived fatigue | Brief Fatigue Inventory: Scale from 0 to 40. Higher scores mean a worse outcome. | One day after the ingestion of the synbiotic or placebo | 
| Questionnarie about perceived depression | Beck´s Depression Inventory: Scale from 0 to 63. Higher scores mean a worse outcome. | One day before the ingestion of the synbiotic or placebo | 
| Questionnarie about perceived depression | Beck´s Depression Inventory: Scale from 0 to 63. Higher scores mean a worse outcome. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the pro-inflammatory cytokine IL-1β (Blood sampling) | Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis. Measured in pg/ml. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the pro-inflammatory cytokine IL-1β (Blood sampling) | Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis. Measured in pg/ml. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the anti-inflammatory cytokine IL-10 (Blood sampling) | Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis. Measured in pg/ml. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the anti-inflammatory cytokine IL-10 (Blood sampling) | Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis. Measured in pg/ml. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the stress hormones Cortisol (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The DetectX Cortisol Immunoassay Kit. Measured in µg/dl. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the stress hormones Cortisol (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The DetectX Cortisol Immunoassay Kit. Measured in µg/dl. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human ACTH (Adrenocorticotropic Hormone) ELISA Kit (Elabscience, USA). Measured in pg/ml. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human ACTH (Adrenocorticotropic Hormone) ELISA Kit (Elabscience, USA). Measured in pg/ml. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the corticotropin-releasing hormone (CRH) (Blood sampling) | Analyzed 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. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the corticotropin-releasing hormone (CRH) (Blood sampling) | Analyzed 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. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the stress hormones serotonin (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General 5-Hydroxytryptamine (5-HT) RD-5-HT-Ge. Measured in ng/ml. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the stress hormones serotonin (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General 5-Hydroxytryptamine (5-HT) RD-5-HT-Ge. Measured in ng/ml. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the catecholamine dopamine (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Dopamine Research Immunoassay Measured in ng/ml. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the catecholamine dopamine (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Dopamine Research Immunoassay Measured in ng/ml. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the catecholamine epinephrine (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Epinephrine (EPI) RD-EPI-Ge-96T. Measured in pg/ml. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the catecholamine epinephrine (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Epinephrine (EPI) RD-EPI-Ge-96T. Measured in pg/ml. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the catecholamine norepinephrine (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Noradrenaline (NE) RD-NE-Ge-96T. Measured in pg/ml. | One day before the ingestion of the synbiotic or placebo | 
| Determination of the catecholamine norepinephrine (Blood sampling) | Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Noradrenaline (NE) RD-NE-Ge-96T. Measured in pg/ml. | One day after the ingestion of the synbiotic or placebo | 
| Determination of the immunoglobulin A (Saliva sampling) | Analyzed 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 | One day before the ingestion of the synbiotic or placebo | 
| Determination of the immunoglobulin A (Saliva sampling) | Analyzed 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 | One day after the ingestion of the synbiotic or placebo | 
| Determination of glucose levels (metabolic profile) | The 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 | One day before the ingestion of the synbiotic or placebo | 
| Determination of glucose levels (metabolic profile) | The 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 | One day after the ingestion of the synbiotic or placebo | 
| Determination of total cholesterol levels (metabolic profile) | The 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 | One day before the ingestion of the synbiotic or placebo | 
| Determination of total cholesterol levels (metabolic profile) | The 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 | One day after the ingestion of the synbiotic or placebo | 
| Determination of the triglycerides levels (metabolic profile) | The 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 | One day before the ingestion of the synbiotic or placebo | 
| Determination of the triglycerides levels (metabolic profile) | The 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 | One day after the ingestion of the synbiotic or placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, immunity, inflammation, prebiotic, probiotic, sedentarism, soccer, stress, synbiotic