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

Sedentary Behavior Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776772
• Other study ID #: CE031810
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2021
• Source: Catholic University of Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 30, 2019
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Athlete
• Sedentary Behavior

Intervention

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
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).

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Determination of the pro-inflammatory cytokine IL-1ß (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
Primary	Determination of the pro-inflammatory cytokine IL-1ß (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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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