Analysis of the Impact of Used Probiotic Strains and Diet on Body Composition, Cardiopulmonary Efficiency and the Incidence of Gastrointestinal Disorders in Runners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Influence of probiotic Sanprobi Barrier on the occurrence of gastrointestinal disorders of long-distance runners.
研究概览
简要总结
The aim of the study was to assess the diet and the effect of probiotic therapy on reducing the incidence of gastrointestinal disorders and selected parameters determining the inflammation of the body, body composition, cardiopulmonary efficiency and selected serum biochemical parameters.
70 competitors took part in the study. The research was carried out at the Department of Dietetics and Clinical Nutrition (Medical University of Bialystok), Fitness Club Maniac Gym in Bialystok, as well as at the Hematological Diagnostics Department and the Biochemical Diagnostics Department of the University Teaching Hospital in Bialystok.
The study was randomized using a double-blind trial. 35 persons selected in the draw were G1 group and the remaining G2 group (n=35). The intervention factor was the SANPROBI BARRIER multi-strain probiotic or placebo. Competitors used probiotic/ placebo for three months at a dose of 2x2 capsules daily (2.5 x 10 9 CFU / g (1 capsule)). The consent of the Bioethics Committee of the Medical University, no. RI-002/81/2017, was obtained for the study.
The study consisted of two stages (W1 and W2), and each stage was associated with three visits by the participants. The first of these (W1) included qualification for the study, completing the questionnaire and 3-day nutrition diaries. At the second visit, body composition analysis and cardiopulmonary efficiency test on a medical treadmill were performed. For morphological tests (blood count with smear, lipid profile, fasting glucose, C-reactive protein and ionogram) at the third visit for each competitor was collected blood from the vein in the amount of 10 ml. The final stage (W2) included similar three visits, where the first visit was made after 3 months of taking product A or B. 66 competitors took part in it.
详细描述
The aim of the study was to assess the diet and the effect of probiotic therapy on reducing the incidence of gastrointestinal disorders and selected parameters determining the inflammation of the body, body composition, cardiopulmonary efficiency and selected serum biochemical parameters.
The approved of the Bioethics Committee of the Medical University, no. RI-002/81/2017, was obtained for the study. 70 people meeting the inclusion criteria were included in the intervention and observational study. The research was carried out at the Department of Dietetics and Clinical Nutrition at the Faculty of Health Sciences of the Medical University of Bialystok, Fitness Club Maniac Gym in Bialystok, as well as at the Hematological Diagnostics Department and the Biochemical Diagnostics Department of the University Clinical Hospital in Bialystok.
The study took place in the spring (March-June 2018) and autumn (September-December 2018), i.e. during of the most intense period in terms of participation in runners' competitions. The study was randomized using a double-blind trial. 35 persons selected in the draw were G1 group and the remaining G2 group (n=35). The tests were completely anonymous, the competitors gave their informed written consent to carry them out.
Interventional study was conducted using a probiotic or placebo. The observation period lasted three months. The intervention factor was the SANPROBI BARRIER multi-strain probiotic (commonly available in pharmacies) or placebo (created on the model of a probiotic capsule, specially for the needs of research, by Sanprobi Sp. z o.o.). Competitors used probiotic/ placebo for three months at a dose of 2x2 capsules daily (2.5 x 10 9 CFU / g (1 capsule)). The probiotic used in the study contained bacterial strains, i.e. Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Lactobacillus salivarius W24. Players and researchers were not informed about the type of capsule taken (probiotic or placebo). Competitors were asked to use product A or B after blood tests.
Each player had 3 visits during the preliminary stage (W1) and 3 visits of the final stage (W2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women and men aged 20-60,
- •running trainings over 5 km/day
排除标准
- •use (other than in research) probiotics
- •pacemaker
结局指标
主要结局
Influence of probiotic Sanprobi Barrier on the occurrence of gastrointestinal disorders of long-distance runners.
时间窗: 12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)
Subjective assessment (survey) of changes in the incidence and severity of gastrointestinal disorders in group of long-distance runners. Another survey at the beginning and end of the study.
Influence of probiotic Sanprobi Barrier on general inflammation of the body.
时间窗: 12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)
Assessment of changes in parameters (C-reactive protein, TNF-alpha, IL-6) from blood.
Influence of probiotic Sanprobi Barrier on the cardiopulmonary efficiency of long-distance runners.
时间窗: 12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)
Assessment of changes in cardiopulmonary efficiency of long-distance runners (testing the player's efficiency on a medical treadmill with the use of a sport tester and an oxygen mask. Bruce Test Protocol).
Influence of probiotic Sanprobi Barrier on blood biochemical parameters.
时间窗: 12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)
Assessment of changes in parameters (complete blood count with smear, fasting glucose, total cholesterol, HDL, LDL and triglycerides, sodium, iron, potassium, magnesium, serum calcium) from blood.
Influence of probiotic Sanprobi Barrier on the body composition of long-distance runners.
时间窗: 12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)
Assessment of runner's body composition changes (body composition analysis used InBody 770 body composition analyzer). The following parameters were assessed: body weight (kg), body fat content in kilograms and percent, visceral fat content (cm2), skeletal muscle mass (kg), body water content (kg).
次要结局
未报告次要终点