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

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.

Study Overview

• Status: Completed
• Conditions: Sedentary Behavior; Athlete
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Synbiotic complement

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Soccer player placebo; Soccer player consuming placebo sticks filled with 300 mg excipient of maltodextrin	Dietary supplement: Placebo; 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).
Experimental: Soccer player synbiotic; 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; 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).
Placebo Comparator: Sedentary individuals placebo; Sedentary individuals consuming placebo sticks filled with 300 mg excipient of maltodextrin	Dietary supplement: Placebo; 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).
Experimental: Sedentary individuals synbiotic; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Catholic University of Murcia
• Investigators: Principal Investigator: Carmen Quero, PhD, Catholic University of Murcia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): June 16, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: prebiotic; probiotic; synbiotic; anxiety; stress; inflammation; soccer; immunity; sedentarism
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Complement System Proteins
• Other Study ID Numbers: CE031810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The raw data supporting the conclusions of this intervention will be made available by the investigators, without undue reservation, to any qualified researcher
• IPD Sharing Time Frame: The data will be always available upon reasonable request
• IPD Sharing Access Criteria: The data that support the findings of this study are available via email from the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No