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临床试验/NCT05281198
NCT05281198终止不适用

Effects of Exercise & Tart Cherry Ingestion on Heat Acclimation and Gut Microbiome

Ohio University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Change in Plasma melatonin content

研究概览

简要总结

The purpose of this study is to determine whether tart cherry supplementation effects thermotolerance and heat acclimation in human subjects exposed to exercise/heat stress.

Specific Aim I. To determine if tart cherry in combination with repeated bouts of thermally stressful exercise will impact the gut microbiome & inflammation measured via stool sample & blood samples for plasma endotoxin, inflammatory cytokines and HSP.

Specific Aim II. To determine whether whole body hyperthermia causes changes in bacterial populations in the gut microbiome, and if these changes are affected by washout or re-acclimation.

Specific Aim III. To determine whether tart cherry supplementation suppresses the ability of human subjects to acclimate to exercise/heat stress. This will be assessed via body temperature, heart rate, sweat and plasma volume responses, and exercise performance during standardized heat tolerance tests.

详细描述

10 recreationally trained cyclists will be recruited and will complete the study in counter-balanced randomized order (5 will start with placebo and 5 will start with tart cherry juice, then have a 4 week washout and complete the other intervention). Participants will complete 15 total sessions in the exercise physiology lab including: a VO2max test, 4 heat stress tests (pre- and post-acclimation) and 5 consecutive days of heat acclimation sessions (twice).

The VO2max test will be an incremental cycling test, starting at 80 Watts and increasing 25 Watts per minute until fatigue. The maximal Wattage will be used to determine exercise intensity during the heat stress test and heat acclimation sessions.

The heat stress test and heat acclimation sessions will occur in a controlled environment of 38C and 25% humidity. Airflow will be provided with a fan at 1 m/s. Prior to entering the controlled environment, participants will provide a mid-stream urine sample to assess hydration status via urine specific gravity (USG) and osmolality (Vapro, ELITech), then empty their bladder, measure their nude body mass on a scale (in a private bathroom in the lab), and self-insert a rectal thermometer 10cm past the anal sphincter. If the participant is dehydrated, they will be instructed to drink 500 ml of water and wait to start exercise until their hydration level is normal (USG<1.020, urine osmolality 500 800 mOsm). Researchers will then affix skin temperature sensors to the participants chest, arm, thigh, and calf and a heart rate monitor to their chest. Participants will the enter the heat chamber and sit on the bicycle for 5 minutes to get acclimated to the environment and to obtain resting levels of thermal sensation and perceived effort. Following these 5 minutes, the participant will commence exercise (described below). Participants will be provided water kept in the controlled environment (to avoid cooling) to consume ad libitum throughout all exercise sessions. Following the exercise session, participants will exit the controlled environment and void their bladder, collecting all urine in a cylinder and towel dry and assess their nude body mass. These will be used along with volume of water consumed during exercise to assess body mass changes and sweat rate.

Heat stress test:

The heat stress test will consist of cycling at 40% of their maximal Watt output for 45 minutes, followed by a 5k time trial, where they will cover the 5k in as fast a time as possible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 18-55 years old
  • Recreational cyclists (>150 minutes per week of cycling exercise)
  • VO2max >60th percentile according to ACSM

排除标准

  • Previous episode of heat illness, such as heat syncope, heat exhaustion or heat stroke
  • Known cardiopulmonary disease, metabolic disorders, Parkinsons Disease, or multiple sclerosis or other autonomic nervous system conditions
  • diagnosed with or being treated for arthritis or any inflammatory condition (such as Lupus, gout, or Sjogrens syndrome)
  • Known or suspected orthostatic hypotension or low blood pressure
  • Known issues with cooling or sweating
  • currently smoke or quit smoking less than one year ago
  • not willing to self-insert a flexible, thin (3 mm) vinyl rectal probe and maintain this position throughout all exercise sessions.
  • not willing to have blood drawn pre-supplementation and 4 times during heat stress test trials (a total of 10 times during the study).
  • not willing to provide a stool sample pre- and post-heat stress tests (4 total samples).
  • allergy to cherries or food dyes

结局指标

主要结局

Change in Plasma melatonin content

时间窗: pre- heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Plasma melatonin content from pre to post supplementation

Change in Plasma TNF-a

时间窗: pre, 1 hour post heat tolerance test

Plasma TNF-a changes from pre to 1 hour post heat tolerance test

Change in Plasma HSP70

时间窗: pre, 1 hour post heat tolerance test

Plasma HSP70 changes from pre to 1 hour post heat tolerance test

Change in Plasma IL-6

时间窗: pre, 1 hour post heat tolerance test

Plasma IL-6 changes from pre to 1 hour post heat tolerance test

Change in Core temperature response to heat tolerance test

时间窗: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Core temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress

Change in Skin temperature response to heat tolerance test

时间窗: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Skin temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress

Change in Mean body temperature response to heat tolerance test

时间窗: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Mean body temperature response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress

Change in Heart rate response to heat tolerance test

时间窗: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Heart rate response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress

Change in Physiological strain response to heat tolerance test

时间窗: heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Physiological strain response to heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress

Change in gut microbial content

时间窗: pre- heat tolerance test 1 (before study onset) and 2 (day 6 of exercise/heat stress)

Gut microbial content from pre to post supplementation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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