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临床试验/NCT05588674
NCT05588674已完成不适用

Investigating a Novel Multi-strain Probiotic Supplement on Indices of Exercise Performance and Recovery

Loughborough University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Recovery from Muscle Soreness

研究概览

简要总结

This project will involve administering a multi-strain probiotic supplement to investigate the capacity to improve exercise performance and/or recovery. This will be done by assessing physiological measures (e.g. performance and muscle soreness), biochemical measures (e.g. oxidative stress and inflammation), and microbial diversity (i.e. associations with bacteria present in the gut). Participants will be well-trained, recreational exercisers and will visit the laboratory a total of eight times, including an 8-week probiotic vs placebo supplementation period.

详细描述

A total of 36 healthy, and active men and women aged 18-40 years of age will be recruited and allocated randomly into either a probiotic or placebo group, where both the investigator and participants will be blinded to the supplements (double-blind randomised control trial format).

Each participant will be asked to attend the research laboratory on eight separate occasions and to refrain from high-intensity exercise (e.g. long-distance running, competitive sport, weightlifting) in the 48 hours prior to each visit and light exercise (e.g. mild jogging or long walk) the day before each visit. They will also be asked to refrain from alcohol intake for 24 hours before each visit and caffeine intake on the morning of the visit.

Visit 1

Following consent, the participants will complete a ramp incremental exercise test for determination of volume of peak oxygen uptake (VO2peak) and the first abrupt change in the oxygen (VO2) and carbon dioxide (VCO2) concentrations of the expired air known as Gas Exchange Threshold (GET). The data collected during the incremental test will be used to calculate the work rates which will be employed during the subsequent exercise tests. The participant will also be asked to complete a food frequency and exercise questionnaire to understand general dietary and training practices.

Visit2

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-40
  • Involved in regular or structured exercise/sport programmes

排除标准

  • Current use or previous use within 3 months of probiotic supplements
  • Current use or previous use within 3 months of antibiotics
  • A recent history of surgery/injury associated with impairment of cycling performance
  • History of chronic disease (excluding mild asthma)
  • Poor tolerance to any component of the supplement
  • Any blood-borne disorder/disease

结局指标

主要结局

Recovery from Muscle Soreness

时间窗: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of muscle soreness using VAS scales and handheld pain threshold algometer

Exercise Performance

时间窗: 8 weeks

Pre- and post-supplementation levels of exercise performance tested via a cycle ergometer time trial

Functional Exercise Recovery

时间窗: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of counter movement jump height

Biochemical Recovery from Exercise (Tissue Damage)

时间窗: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of markers of muscle damage (CK, LDH) by immunoassay

Biochemical Recovery from Exercise (Oxidative Stress)

时间窗: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of markers of oxidative stress (8-OHDG, MDA) by immunoassay

Biochemical Recovery from Exercise (Inflammation)

时间窗: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of inflammatory markers (IL-6, CRP) by immunoassay

次要结局

  • Gut Microbial Diversity Testing by 16S Sequencing(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liam Heaney

Senior Lecturer/Principal Investigator

Loughborough University

研究点 (2)

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