The Effect of a Synbiotic Formulation on Endurance Exercise Performance in Trained Cyclists: A Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in endurance exercise performance measured during a 20km cycling distance trial
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.
The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health.
详细描述
The goal of this randomized double-blinded clinical trial is to evaluate the potential beneficial effects of a synbiotic formulation on exercise performance in trained adult cyclists. The main questions it aims to answer are related to the Synbiotic effects on:
- Cycling performance
- Exercise metabolism
- Gastrointestinal health
- Immune system
- Body composition
- Fecal Short Chain Fatty Acids (SCFAs)
- Fecal microbiome composition
Participants will be recruited and, if consenting and eligible, will undergo the initial pre-testing phase for baseline assessment (4 on-site visits). Then, they will be randomized to receive the synbiotic or placebo and instructed to consume one sachet daily for 42 consecutive days. After 4-5 weeks of intervention (Day 33), post-testing phase will start, and participants will be asked to return to the site to perform post testing assessments (over 4 on-site visits). Study visits will occur as follows, V1 (Day -9), V2 (Day -6), V3 (Day -3), V4 (Day 0), V5 (Day 33), V6 (Day 36), V7 (Day 39), and V8 (Day 42).
Researchers will compare the assessed outcomes to baseline in each group and evaluate the difference between groups following the synbiotic consumption to highlight any statistically and clinically relevant observations.
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)
盲法说明
The synbiotic and placebo are both powders identical in taste and appearance and are equally dissolvable in cold water.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between the ages of 18-45
- •Currently cycling for at least 3 hours per week for the past 3 months
- •Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise
- •Have a resting heart rate <100 bpm and resting systolic and diastolic blood pressures <160 mmHg and <90 mmHg, respectively.
排除标准
- •Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period)
- •Current laxative use
- •Are a smoker or use tobacco products
- •Consume >21 units of alcohol per week
- •Have donated blood in the previous 3 months
- •Have a BMI ≥30kg/m2
- •Are pregnant or lactating or planning to become pregnant for the duration of the study
- •Are dieting for weight loss or are following a low carbohydrate diet
- •Have participated in another clinical trial within the 30 days preceding study enrollment
- •Are taking medications known to affect cardiovascular or metabolic responses to exercise
- •Have a medical condition that could interfere with study intervention and assessment
- •Have current musculoskeletal injuries that limit exercise capacity
- •Are non-English speaking
研究组 & 干预措施
Synbiotic
Participants receive the synbiotic for 6 weeks.
干预措施: Synbiotic (Dietary Supplement)
Placebo
Participants receive the placebo for 6 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in endurance exercise performance measured during a 20km cycling distance trial
时间窗: 42 Days
Assessed as time (minutes) to complete 20km cycling distance
次要结局
- Change in maximal oxygen consumption (V̇O2max) measured during a Step-Ramp-Step Test(36 Days)
- Change in peak power output (PPO) measured during a Step-Ramp-Step Test(36 Days)
- Change in power output corresponding to the gas exchange threshold (GET) and respiratory compensation point (RCP)(36 Days)
- Change in body composition measured by dual energy X-ray absorptiometry (DXA)(33 Days)
- Change in cytokines(33 Days)
- Change in gastrointestinal symptoms measured by self-report(33 Days)
- Change in fat and carbohydrate oxidation measured during exercise sessions(36, 39 and 42 Days)
- Change in fecal SCFA concentration measured by gas chromatography(33 Days)
- Synbiotic strains quantification measured by qPCR in fecal matter(33 Days from Day 0)
- Change in blood lactate concentration measured via pinprick capillary blood test(36, 39 and 42 Days)
- Change in time to exhaustion measured during a cycling session at 85% of the peak power output(39 Days)
- Change in intestinal permeability markers measured in serum(33 Days)
- Change in fecal microbiota composition(33 Days)
- Incidence of adverse events(42 Days)
研究者
Dr. Raylene Reimer
Professor
University of Calgary