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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
27
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).
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).
Catholic University of Murcia
Murcia, Spain
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: One day after the ingestion of the synbiotic or placebo
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