AthleteNCT04776772
Health Parameters in Soccer Players and Sedentary Individuals After Consuming a Synbiotic
A study testing Synbiotic complement in people with Athlete and Sedentary Behavior, run by Catholic University of Murcia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athlete, Sedentary Behavior
- What is being tested?
- Synbiotic complement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary individuals: students with low levels of physical activity (≤ 150 minutes/week),
- Athletes: semi professional soccer players
Who cannot join
- Participants were prohibited from consuming probiotics, prebiotics or fermented products (yogurt or other foods)
- Presenting injury or illness
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Athlete, Sedentary Behavior
- Being tested
- Synbiotic complement, Placebo
- Keywords
- anxiety, immunity, inflammation, prebiotic, probiotic, sedentarism, soccer, stress, synbiotic
- Medical subject headings
- Sedentary Behavior, Anxiety Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic complementDietary 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).
PlaceboDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Soccer player placebo | Placebo comparator | Soccer player consuming placebo sticks filled with 300 mg excipient of maltodextrin Receives: 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 Receives: Dietary Supplement: Synbiotic complement |
| Sedentary individuals placebo | Placebo comparator | Sedentary individuals consuming placebo sticks filled with 300 mg excipient of maltodextrin Receives: 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 Receives: Dietary Supplement: Synbiotic complement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: One day after the ingestion of the synbiotic or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start15 May 2019
- Primary completion16 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthleteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Daniela Quero Calero, Catholic University of Murcia
- Investigators
- Carmen Quero, PhD, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776772
- Sponsor's protocol ID
- CE031810
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data supporting the conclusions of this intervention will be made available by the investigators, without undue reservation, to any qualified researcher
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04776772
- Acronym / sponsor ID
- CE031810
- Conditions
- Athlete, Sedentary Behavior
- Keywords
- anxiety, immunity, inflammation, prebiotic, probiotic, sedentarism, soccer, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Catholic University of MurciaUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Soccer player placebo | Placebo comparator | Dietary Supplement: PlaceboSoccer player consuming placebo sticks filled with 300 mg excipient of maltodextrin |
| Soccer player synbiotic | Experimental | Dietary Supplement: Synbiotic complementSoccer 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 |
| Sedentary individuals placebo | Placebo comparator | Dietary Supplement: PlaceboSedentary individuals consuming placebo sticks filled with 300 mg excipient of maltodextrin |
| Sedentary individuals synbiotic | Experimental | Dietary Supplement: Synbiotic complementSedentary 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary individuals: students with low levels of physical activity (≤ 150 minutes/week),
- Athletes: semi professional soccer players
Key exclusion criteria (2 listed)
- Participants were prohibited from consuming probiotics, prebiotics or fermented products (yogurt or other foods)
- Presenting injury or illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic complementOn 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). | Dietary supplement | Sedentary individuals synbiotic, Soccer player synbiotic |
| PlaceboOn 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). | Dietary supplement | Sedentary individuals placebo, Soccer player placebo |
Primary outcome
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: Yes. The raw data supporting the conclusions of this intervention will be made available by the investigators, without undue reservation, to any qualified researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Quero, PhD principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic complement in people with Athlete and Sedentary Behavior, run by Catholic University of Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.