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Completed

NCT Number: NCT04776772

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

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.

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Key information

Conditions

Athlete Anxiety Disorders Behavior Inflammation Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sedentary Behavior

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Catholic University of Murcia

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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