Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04776772
Recruitment Status : Completed
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Carmen Daniela Quero Calero, Catholic University of Murcia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Athlete Sedentary Behavior Dietary Supplement: Synbiotic complement Dietary Supplement: Placebo Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 15, 2019
Actual Primary Completion Date : June 16, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry [ Time Frame: During 7 days before the ingestion of the synbiotic or placebo ]
    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).

  2. Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry [ Time Frame: During 7 days after the ingestion of the synbiotic or placebo ]
    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).

  3. Questionnarie about general health. [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    SF-36 Questionnaire: Scale from 0 to 100. Higher scores mean a better outcome.

  4. Questionnarie about general health. [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    SF-36 Questionnaire: Scale from 0 to 100. Higher scores mean a better outcome.

  5. Questionnarie about anxiety levels (moment) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    The State Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.

  6. Questionnarie about anxiety levels (moment) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    The State Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.

  7. Questionnarie about anxiety levels (personality) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    The Trait Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.

  8. Questionnarie about anxiety levels (personality) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    The Trait Anxiety Inventory (STAI): Scale from 0 to 60. Higher scores mean a worse outcome.

  9. Questionnarie about sleep quality [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    Healthy Lifestyle and Personal Control Questionnaire: Scale from -1 to 10. Higher scores mean a better outcome.

  10. Questionnarie about sleep quality [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    Healthy Lifestyle and Personal Control Questionnaire: Scale from -1 to 10. Higher scores mean a better outcome.

  11. Questionnarie about perceived stress [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    The Perceived Stress Scale: Scale from 0 to 56. Higher scores mean a worse outcome.

  12. Questionnarie about perceived stress [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    The Perceived Stress Scale: Scale from 0 to 56. Higher scores mean a worse outcome.

  13. Questionnarie about perceived fatigue [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    Brief Fatigue Inventory: Scale from 0 to 40. Higher scores mean a worse outcome.

  14. Questionnarie about perceived fatigue [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    Brief Fatigue Inventory: Scale from 0 to 40. Higher scores mean a worse outcome.

  15. Questionnarie about perceived depression [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    Beck´s Depression Inventory: Scale from 0 to 63. Higher scores mean a worse outcome.

  16. Questionnarie about perceived depression [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    Beck´s Depression Inventory: Scale from 0 to 63. Higher scores mean a worse outcome.

  17. Determination of the pro-inflammatory cytokine IL-1β (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis.

    Measured in pg/ml.


  18. Determination of the pro-inflammatory cytokine IL-1β (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis.

    Measured in pg/ml.


  19. Determination of the anti-inflammatory cytokine IL-10 (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis.

    Measured in pg/ml.


  20. Determination of the anti-inflammatory cytokine IL-10 (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    Using the LuminexTM 200 System instrument (Luminex Corporation, Texas, USA) using the ProcartaPlex TM Multiplex Immunoassay for analysis.

    Measured in pg/ml.


  21. Determination of the stress hormones Cortisol (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The DetectX Cortisol Immunoassay Kit.

    Measured in µg/dl.


  22. Determination of the stress hormones Cortisol (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The DetectX Cortisol Immunoassay Kit.

    Measured in µg/dl.


  23. Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human ACTH (Adrenocorticotropic Hormone) ELISA Kit (Elabscience, USA).

    Measured in pg/ml.


  24. Determination of the adrenocorticotropic hormone (ACTH) (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Human ACTH (Adrenocorticotropic Hormone) ELISA Kit (Elabscience, USA).

    Measured in pg/ml.


  25. Determination of the corticotropin-releasing hormone (CRH) (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    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.

  26. Determination of the corticotropin-releasing hormone (CRH) (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    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.

  27. Determination of the stress hormones serotonin (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General 5-Hydroxytryptamine (5-HT) RD-5-HT-Ge.

    Measured in ng/ml.


  28. Determination of the stress hormones serotonin (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General 5-Hydroxytryptamine (5-HT) RD-5-HT-Ge.

    Measured in ng/ml.


  29. Determination of the catecholamine dopamine (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]
    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Dopamine Research Immunoassay Measured in ng/ml.

  30. Determination of the catecholamine dopamine (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]
    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The Dopamine Research Immunoassay Measured in ng/ml.

  31. Determination of the catecholamine epinephrine (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Epinephrine (EPI) RD-EPI-Ge-96T.

    Measured in pg/ml.


  32. Determination of the catecholamine epinephrine (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Epinephrine (EPI) RD-EPI-Ge-96T.

    Measured in pg/ml.


  33. Determination of the catecholamine norepinephrine (Blood sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Noradrenaline (NE) RD-NE-Ge-96T.

    Measured in pg/ml.


  34. Determination of the catecholamine norepinephrine (Blood sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    Analyzed by competitive inhibition enzyme immunoassays (ELISA), using The General Noradrenaline (NE) RD-NE-Ge-96T.

    Measured in pg/ml.


  35. Determination of the immunoglobulin A (Saliva sampling) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    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


  36. Determination of the immunoglobulin A (Saliva sampling) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    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


  37. Determination of glucose levels (metabolic profile) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    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


  38. Determination of glucose levels (metabolic profile) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    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


  39. Determination of total cholesterol levels (metabolic profile) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    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


  40. Determination of total cholesterol levels (metabolic profile) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    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


  41. Determination of the triglycerides levels (metabolic profile) [ Time Frame: One day before the ingestion of the synbiotic or placebo ]

    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


  42. Determination of the triglycerides levels (metabolic profile) [ Time Frame: One day after the ingestion of the synbiotic or placebo ]

    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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776772


Locations
Layout table for location information
Spain
Catholic University of Murcia
Murcia, Spain, 30107
Sponsors and Collaborators
Catholic University of Murcia
Investigators
Layout table for investigator information
Principal Investigator: Carmen Quero, PhD Catholic University of Murcia
  Study Documents (Full-Text)

Documents provided by Carmen Daniela Quero Calero, Catholic University of Murcia:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] March 2, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Carmen Daniela Quero Calero, Professor, principal investigator, Catholic University of Murcia
ClinicalTrials.gov Identifier: NCT04776772    
Other Study ID Numbers: CE031810
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmen Daniela Quero Calero, Catholic University of Murcia:
anxiety
immunity
inflammation
prebiotic
probiotic
 sedentarism
soccer
stress
synbiotic
Additional relevant MeSH terms:
Layout table for MeSH terms
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs