The Effect of Probiotics and Vitamin D Supplementation on Sport Performance and Intestinal Barrier Function in Trained Male Mixed-martial Arts Athletes
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Assessment of changes in body composition c.used by intervention,
研究概览
简要总结
The probiotics supplementation seems to be safety way to optimize the intestinal microbiota composition and thus modulate the immune system and reduce oxidative stress. Moreover it may enhance muscle protein synthesis, mitochondrial biogenesis and function, as well as muscle glycogen storage. Probiotics intake via reduce inflammatory markers and reactive oxygen species production may attenuate macromolecules damage and have some beneficial effect on aerobic and anaerobic performance. The combined probiotics and vitamin D supplementation may enhance this effect. The synergistic intestinal microbiota and vitamin D interaction towards muscle protein synthesis and mitochondrial function improvement may be manifested by mTOR and FOXO signaling influence on oxidative stress as well as immunological functions modulation. In the study investigators will assess if multistrain probiotic mixture in conjunction with vitamin D may have beneficial effect on sport performance among trained male mixed-martial arts athletes. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Researchers are going to evaluate changes in the gut, including microbiome composition and epithelial permeability; differences in the blood parameters as well as direct influence on sport performance, expressed by anaerobic and aerobic fitness capacity. Researchers will provide an evidences, having both theoretical as well as practical aspect.
详细描述
The study is designed as a randomized double-blind placebo-controlled clinical trial with 4-week probiotics and vitamin D intervention period. The study is conducted between December 2020 and March 2021, at the Medical University of Gdańsk, Department of Bioenergetics and Physiology of Exercise (Gdańsk, Poland) . Researchers will enrol 25 trained, male mixed-martial arts athletes. Enrolled athletes will be randomly assigned to receive probiotic (PRO) or matching placebo (PL) in a 1:1 ratio, using Excel random number generator, following the rule of the random and blindness.
The study product is a vitamin D ,,Juvit d3" and probiotic mixture ,,Sanprobi Active & Sport", containing 2,5 x 109 CFU/g per capsule (≥500 million CFU in one capsule) of five strains of lactic acid bacteria (Bifidobacterium lactis W51, Lactobacillus brevis W63, Lactobacillus acidophilus W22, Bifidobacterium bifidum W23 and Lactococcus lactis W5); maize starch, maltodextrin, plant proteins and hydroxypropyl ethylcellulose tablets' coating. Identical-looking placebo capsules containing 40 mg of maltodextrin and plants proteins will be used for cartel. Each pack of probiotic or placebo contain 40 capsules. All athletes will receive a bottle of Juvit d3 as well as three identical-looking packings of probiotics or placebo, depending on the random allocation, at the baseline visit. Participants will be informed to take 4 capsules with meals and 3500 iu of vitamin d daily.
At baseline visit, all subjects will receive the study product as well as diary of supplements and dietary intake and training diary. Both PRE and POST visit will be splitted in two days in order to reliable and appropriate performance of all procedures. The time window between these splitted visit is 3-5 days. Participants will report to the Medical University of Gdańsk at the beginning (PRE) and the end (POST) of the 4-week intervention period. During both visits athletes will complete an assessment of body composition, food frequency questionnaire (FFQ), cardio-respiratory fitness evaluation and will provide fecal samples. Furthermore, the blood samples will be drawn before and after sport tests, to assess selected markers of inflammatory as well as muscle damage state and lactate utilization level. The last one blood collection will be perform after 24 hours of anaerobic sport test. Participant will be instructed to continue their training programme. Athletes will be obligated to perform at least 5 endurance workouts per week to keep the competitive character of the study.
The body composition analysis will be evaluated to detect potential changes within body fat mass and fat free mass. The level of each tissue will be compared to intestinal bacteria content. Investigators will try to explain if gut microbiome composition may affect body composition and which bacterial phyla are responsible for possible for this potential changes. This target will be obtain through multi-frequency bioelectrical impedance analysis (BIA).
Aerobic fitness capacity will be assess through bicycle ergometer ER900 Jaeger using the wasserman protocol. The test will be preceded by a 5-minute warm-up with a load of 100 W, followed by a 5-minute rest. The test will start at a load of 125 W and a frequency of 60 ± 5 RPM / min, the load will be increased every 1 minutes by 25 W. The test will be conducted until the maximum individual exercise load is reached, i.e. the inability to continue the exercise while maintaining the specified frequency or lack of increase oxygen uptake. During examination investigators will monitor the amount of oxygen uptake and carbon dioxide exhaled, minute lung ventilation as well as heart rate. The aerobic test will be conducted 3-5 days before anaerobic assessment as part of PRE and POST visits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male gender
- •signed informed consent
- •minimum 3 years of mixed martial arts training practice
- •realization of minimum 5 workouts weekly
- •participation in 2 competitions at least
排除标准
- •age below 18
- •female gender
- •lack of signed informed consent
- •antibiotic therapy during last 3 months
- •diagnosed inflammatory bowel disease
- •chronic musculoskeletal injuries within last 6 months
- •heart failure or defects
结局指标
主要结局
Assessment of changes in body composition c.used by intervention,
时间窗: The measurement will be perform in the morning, at baseline and follow up visit (before sport tests, before breakfast). The outcome measure will be assessed up to 1 month.
The body composition analysis will be evaluated to detect potential changes within body fat mass and fat free mass. The level of each tissue will be compared to intestinal bacteria content. Investigators will try to explain if gut microbiome composition and vitamin D may affect body composition and which bacterial phyla are responsible for possible for this potential changes. This target will be obtain through multi-frequency bioelectrical impedance anap visit (before sport tests, before breakfast). The outcome measure will be assessed up to 1 month (BIA)
Effect of probiotics and vitamin D supplementation on anaerobic sport performance - evaluation of changes
时间窗: The Wingate test will be perform at baseline and follow up visit. The outcome measure will be assessed up to 3 months .
To assess an effect on sport performance investigators will perform anaerobic triple Wingate test using cycloergometer.
Evaluation of changes in gut microbiome composition caused by intervention.
时间窗: Participants will be obligated to deliver a stool samples at the baseline and follow up visit. The outcome measure will be assessed up to 9 months
Collected stool samples will be assessed with new generation sequencing method. Selected hypervariable regions of the 16SrRNA gene will be analyzed. The composition of the microbiome will be characterized primarily by alpha and beta diversity. Diversity of microbial communities in one sample (alpha) will be measured using several indicators, such as Chao1, ACE, Shannon and inverted Simpson. During the analysis investigators will assess presence of short-chain fatty acid.
Effect of probiotics and vitamin D supplementation on aerobic sport performance - evaluation of changes
时间窗: Aerobic test will be perform 3-5 days before/after anaerobic test. The outcome measure will be assessed up to 3 months.
To assess an effect on aerobic sport performance investigators will perform aerobic (cardio-pulmonary exercise test) as well as anaerobic test (triple Wingate test) using cycloergometer. Additionally the capillary blood will be collected to assess the level of lactate concentration as well as rate of lactate utilization.
Effect of probiotics and vitamin D supplementation on lactate utilization - evaluation of changes
时间窗: Capillary blood will be collected in 5 time points, directly before Wingate test, 3, 15, 30 and 60 minutes after test.The outcome measure will be assessed up to 3 months
The capillary blood will be collected to assess the level of lactate concentration as well as rate of lactate utilization.
The effect of probiotics and vitamin D supplementation on inflammatory state- the evaluation on changes between baseline and follow up visit.
时间窗: The arm vein blood will be collected at baseline as well as follow up visit at three time points - before breakfast and sport tests, 35 minutes after anaerobic tests and 24 hours after Wingate test. The outcome measure will be assessed up to 6 months
The collected venous blood samples will be subjected to analysis at the Medical The effect of probiotics and vitamin D supplementation on inflammatory state - the evaluation on changes between baseline and follow up visit. The outcome measure will be assessed up to 6 monthsUniversity of Gdańsk. Investigators will assess the level of serum pro-inflammatory cytokines (IL-6 and TNF-α) as well as anti-inflammatory cytokines (L-2 and IL-15) using a commercially available enzyme-linked immunosorbent assay (ELISA) kits.
The effect of probiotics and vitamin D supplementation on muscle damage - the evaluation on changes between baseline and follow up visit.
时间窗: The arm vein blood will be collected at baseline visit at three time points - before breakfast and sport tests, 35 minutes after anaerobic tests and 24 hours after Wingate test. The outcome measure will be assessed up to 6 months .
The collected venous blood samples will be subjected to analysis at the Medical University of Gdańsk.Investigators will assess changes in creatine kinase level through kinetic method, using the commercially available kit.
Evaluation of changes in the gut on epithelial permeability
时间窗: Participants will be obligated to deliver a stool samples at the baseline and follow up visit. The outcome measure will be assessed up to 9 months
Collected stool samples will be assessed in the context intestine barrier permeability as zonulin, calprotectin and FABP.
次要结局
未报告次要终点