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临床试验/NCT06501898
NCT06501898终止不适用

Tributyrin: Time Course & Efficacy to Improve Health & Performance

Florida State University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2024年8月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Metabolite Concentration

研究概览

简要总结

The purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. Participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.

研究设计

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

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age: 30-50 years
  • •Sedentary (<150 minutes of aerobic exercise per week)

排除标准

  • •Chronic, uncontrolled metabolic, cardiovascular, gastrointestinal, or hepatic disease
  • •Consumption of supplements known to impact the microbiome, hydration status, core temperature, or exercise performance
  • •Experienced previous heat illness
  • •Known injuries that limit exercise
  • •BMI ≥ 40 kg/m^2

研究组 & 干预措施

CoreBiome

Active Comparator

Participants will be given tributyrin (as CoreBiome)

干预措施: CoreBiome (Dietary Supplement)

Placebo

Placebo Comparator

Participants will be given a taste-, color-, and odor-matched placebo

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Metabolite Concentration

时间窗: 2 and 4 weeks after onset of CoreBiome supplementation; 2 and 4 weeks after onset of Placebo supplementation

Fecal butyrate concentration

次要结局

  • Perceived exertion (mid-exercise)(During exercise bout)
  • Sleep quantity(Four weeks prior to day of exercise bout)
  • Gut permeability(10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise))
  • Inflammation(10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise))
  • Sleep Quality(Four weeks prior to day of exercise bout)
  • Maximum sprint power (mid-exercise)(During exercise bout)
  • Immune cell composition(10 minutes before and 5 minutes prior to completion of exercise bout (i.e., mid-exercise))
  • Substrate Utilization (mid-exercise)(During exercise bout)
  • Average sprint power (mid-exercise)(During exercise bout)
  • Total completed distance (mid-exercise)(During exercise bout)

研究者

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

Michael J. Ormsbee

Professor

Florida State University

研究点 (1)

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