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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Questionnarie about perceived depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sedentary individuals: students with low levels of physical activity (≤ 150 minutes/week),
- •Athletes: semi professional soccer players
排除标准
- •Participants were prohibited from consuming probiotics, prebiotics or fermented products (yogurt or other foods)
- •Presenting injury or illness
结局指标
主要结局
Questionnarie about perceived depression
时间窗: 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 adrenocorticotropic hormone (ACTH) (Blood sampling)
时间窗: 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)
时间窗: 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)
时间窗: 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 anti-inflammatory cytokine IL-10 (Blood sampling)
时间窗: 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)
时间窗: 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.
Questionnarie about anxiety levels (personality)
时间窗: 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.
Objective determination of levels of physical activity, sedentary lifestyle and sleep quality: accelerometry
时间窗: 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.
时间窗: 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 perceived stress
时间窗: 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.
Determination of the catecholamine epinephrine (Blood sampling)
时间窗: 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)
时间窗: 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 glucose levels (metabolic profile)
时间窗: 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
Questionnarie about anxiety levels (moment)
时间窗: 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 sleep quality
时间窗: 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 fatigue
时间窗: One day after the ingestion of the synbiotic or placebo
Brief Fatigue Inventory: Scale from 0 to 40. Higher scores mean a worse outcome.
Determination of the pro-inflammatory cytokine IL-1β (Blood sampling)
时间窗: 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 catecholamine dopamine (Blood sampling)
时间窗: 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 immunoglobulin A (Saliva sampling)
时间窗: 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 total cholesterol levels (metabolic profile)
时间窗: 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)
时间窗: 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
次要结局
未报告次要终点
研究者
Carmen Daniela Quero Calero
Professor, principal investigator
Catholic University of Murcia