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

NCT04776772 | Completed DMC

• 1 other identifier: CE031810
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Athlete; Sedentary Behavior

Keywords

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

Outcome Measures

Primary Outcomes (42)

• 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

Study Arms (4)

Soccer player placebo

PLACEBO COMPARATOR

Soccer player consuming placebo sticks filled with 300 mg excipient of maltodextrin

Dietary Supplement: Placebo

Soccer player synbiotic

EXPERIMENTAL

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

Sedentary individuals placebo

PLACEBO COMPARATOR

Sedentary individuals consuming placebo sticks filled with 300 mg excipient of maltodextrin

Dietary Supplement: Placebo

Sedentary individuals synbiotic

EXPERIMENTAL

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

Interventions

Synbiotic complement DIETARY_SUPPLEMENT

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).

Sedentary individuals synbiotic; Soccer player synbiotic

Placebo DIETARY_SUPPLEMENT

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).

Sedentary individuals placebo; Soccer player placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Sedentary Behavior; Anxiety Disorders; Inflammation

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen Quero, PhD

  Catholic University of Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, principal investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 2, 2021
• Study Start: May 15, 2019
• Primary Completion: June 16, 2019
• Study Completion: June 30, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be always available upon reasonable request
• Access Criteria: The data that support the findings of this study are available via email from the corresponding author upon reasonable request.

Locations

ES (1)