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临床试验/NCT04779281
NCT04779281已完成不适用

Effects of Nutritional Status and Probiotics on Exercise-Related Clinical and Gastrointestinal Symptoms and Endurance Performance in Ultra-Endurance Athletes

Istanbul Medeniyet University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Changes of the gut microbiome after a 4-week supplementation period

研究概览

简要总结

Ultra-endurance athletes have been commonly endured extreme conditions during races and training sessions, resulting in exercise-associated clinical symptoms, including gastrointestinal symptoms, dehydration, and elevated oxidative stress. Although these alterations adversely affect sports performance and well-being, there is no certain treatment or consensus on alleviating the exercise-associated clinical symptoms in ultra-endurance athletes. The objective of this study is to determine the effects of oral rehydration salts supplemented with Lactobacillus Rhamnosus GG on exercise-induced gastrointestinal problems, dehydration and oxidative stress in ultra-endurance athletes. Additionally, we aimed to assess the exercise-induced alterations in oxidative stress determined by applying an acute strenuous exercise protocol ((a cycle ergometer (45 min at 65%VO2max) immediately followed by a treadmill test (75% VO2max to exhaustion)) before and after the supplementation period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who train at least 15 h per week,
  • Participants who do not have any metabolic disease,
  • Have had at least one gastrointestinal symptom determined by using a Gastrointestinal Symptoms Rating Scale and Bristol Stool Chart Form Scale,
  • Being a non-smoker,
  • Have participated in at least one ultra-endurance race/event (lasts > 4 hr),
  • Taking no vitamins, minerals, dietary supplements, antibiotics, and any medication at least during the three months before the study,
  • (For women) participants with a regular menstrual cycle of physiological length (24-35 days)

排除标准

  • Regular tobacco use
  • Inability to adhere to any of the study protocol requirements (i.e. alcohol, caffeine consumption, diet control)
  • Having consumed any supplements and/or medicines for the preceding 3 months period.
  • (For women) participants in menopause or using oral contraceptives

结局指标

主要结局

Changes of the gut microbiome after a 4-week supplementation period

时间窗: Change from Baseline Gut Microbiome at 4 weeks

- To assess the profile of gut flora (% abundance of various bacterial phyla, families, genera and species) at baseline and after supplementation in ultra-endurance athletes, using a 16S ribosomal RNA sequencing

次要结局

  • Changes in blood markers of exercise-associated oxidative stress (8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity in plasma)(4 weeks)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asli Devrim Lanpir

Research Assistant, PhD

Istanbul Medeniyet University

研究点 (2)

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