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临床试验/NCT05632692
NCT05632692尚未招募不适用

Menthol Mouth Rinsing and Performance Responses of Elite Football Referees in the Heat: a Randomized Crossover Trial

Universidade do Porto0 个研究点目标入组 10 人开始时间: 2023年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
主要终点
Heart rate change

研究概览

简要总结

Ten male football referees will be recruited to perform two intermittent football protocols , separated by at least 7 days (wash-out period). After passing the eligibility criteria, the participants will be randomly assigned, according to a computer-generated allocation schedule, to 1 of 2 beverages sequences: (1) intervention - menthol solution 0.01% (room temperature) and (2) placebo - noncaloric berry-flavoured solution (room temperature). The participants will be provided with one of the 2 beverages before warm-up (pre-cooling) and at the half-time (per-cooling). The trials will follow a randomised counterbalanced crossover design, blinded to the participants, and will take place in indoor facilities, where WBGT exceed 30◦C, at the same time of the day, to control for circadian variations. Each trial involves an exercise protocol (SAFT-90), lasting 90 minutes, separated into two 45-minute parts. The first half will be preceded by a warm-up and the second half by a 15-minute break.

The results of this study are expected to determine whether mouth rinsing a menthol solution, before a football exercise protocol performed in the heat, will help to alleviate physiological strain and improve performance parameters, comparing to a non-cooling strategy, in elite male football referees. Thus, we can be closer to defining nutritional strategies of internal cooling, that will be an advantage for the performance of the football referees, concretely in the competitions carried out under adverse environmental conditions.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Male football referees aged over 18 and under 45 years;
  • •With normal weight (BMI ≥ 18.5 and ≤ 24.9 kg/m2);
  • •Availability to participate in the introductory meeting, familiarization session and 2 experimental sessions;
  • •Ability to read and sign the informed consent.

排除标准

  • •Under the influence of any medications that may affect urinary parameters, thermoregulation mechanisms, circulatory system, thyroid and pituitary function or metabolic status;
  • •Injury, diabetes, autoimmune disease, cardiovascular disease or obstructive disease of the gastrointestinal tract (e.g., diverticulitis, inflammatory bowel disease);
  • •Schizophrenia, bipolar disorder or other psychotic disorders;
  • •Eating disorders;
  • •MRI scans scheduled within 48 hours after familiarization session or any of the experimental trials.

研究组 & 干预措施

Intervention

Experimental

A menthol solution is going to be formulated by crushing and dissolving one noncalorific menthol candy drop (15 mg) in 150 ml of warm water, in order to obtain a solution with a concentration of 0.01%. Prior to use, solutions are going to be aliquoted for mouth rinse and warmed at room temperature. Then, it will be served to each participant on individual bottles in a total dose of 75 ml before exercise and 75 ml during exercise.

干预措施: Menthol solution (Other)

Placebo

Placebo Comparator

A placebo beverage is going to be prepared using noncaloric berry-flavored sweetener consisting of sucralose candy drops, which will be crushed and dissolved in 150 ml of warm water. Prior to use, solutions are going to be aliquoted for mouth rinse and warmed at room temperature. Then, it will be served to each athlete on individual bottles in a total dose of 75 ml before exercise and 75 ml during exercise.

干预措施: Menthol solution (Other)

结局指标

主要结局

Heart rate change

时间窗: A change in heart rate from baseline (immediately before exercise) to each 15-minute block of the exercise protocol will be assessed.

Heart rate is a physiological parameter of performance and will be measured through HR monitors (Polar H10 Heart Rate Sensor, USA). PolarH10 can accurately measure mean HR and low-frequency oscillations (up to 0.15 Hz) of HR at rest and during exercise.

Ratings of perceived exertion (RPE)

时间窗: RPE is going to be accessed at the end of the exercise protocol.

RPE is a subjective psychological/perceptual parameter that impacts performance and will be recorded through CR-10 Borg scale that goes from 0 ("rest") to 10 ("maximal effort").

Thermal comfort (TC) change

时间窗: A change in TC from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.

TC is a subjective psychological/perceptual parameter that influences performance and is going to be accessed according to a 6-point scale from to -3 ("very uncomfortable) to 3 ("very comfortable").

Thermal sensation (TS) change

时间窗: A change in TS from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.

TS is a subjective psychological/perceptual parameter that impacts performance and will be recorded with a 9-point scale from -4 ("very cold") to 4 ("very warm").

Sweating rate at the first half

时间窗: Sweating rate is going to be calculated at the end of the first half of the exercise protocol (after 45 min of exercise)

Sweating rate is a physiological parameter of performance and is going to be calculated recurring to the following equation : SR= (Pre exercise body weight - postexercise body weight + fluid intake - urine volume)/(exercise time in hours).

Sweating rate at the second half

时间窗: Sweating rate is going to be calculated at the end of the second half of the exercise protocol (after 90 min of exercise)

Sweating rate is a physiological parameter of performance and is going to be calculated recurring to the following equation : SR= (Pre exercise body weight - postexercise body weight + fluid intake - urine volume)/(exercise time in hours).

Core temperature change

时间窗: A change in core temperature from baseline (immediately before exercise) to each 15-minute block of the exercise protocol will be assessed

Core temperature is a physiological parameter of performance and can be accessed using a telemetric pill ingested 30 minutes prior the start of the exercise (BodyCap®, France). Due to the good measuring accuracy, the ability to measure in field-based situations and the non-invasive character of this temperature measurement method, the ingestible telemetric temperature pill is suitable to assess core temperature during exercise

Perceived thirst (PT) change

时间窗: A change in PT from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.

PT is a subjective marker of hydration status and will be evaluated recurring to a 7-point scale from 1 ("not thirsty at all") to 7 ("very, very thirsty")

Physical performance change

时间窗: A change in each physical performance indicator from baseline (immediately after the warm-up) to each 15-minute block of the exercise protocol will be assessed

Physical performance responses will be measured using 100 Hz accelerometery, with Sonda 4.0 software (StatSports®, UK) to estimate total distance, sprint distance, accelerations and decelerations number

次要结局

  • Hydration status before(Hydration status is going to be recorder at baseline (pre-exercise))
  • Hydration status after(Hydration status is going to be recorder at the end of the exercise protocol)
  • Ad libitum fluid intake at the first half(Ad libitum fluid intake is going to be assessed at the end of the first half of the exercise protocol (after 45 min of exercise))
  • Ad libitum fluid intake at the second half(Ad libitum fluid intake is going to be assessed at the end of the second half of the exercise protocol (after 90 min of exercise))
  • Blood glucose levels after(Blood glucose levels are going to be recorded immediately after the end of the exercise protocol)
  • Blood lactate levels before(Blood lactate levels are going to be recorded before the start of the exercise protocol)
  • Blood glucose levels before(Blood glucose levels are going to be recorded before the start of the exercise protocol)
  • Blood lactate levels after(Blood lactate levels are going to be recorded immediately after the end of the exercise protocol)

研究者

申办方类型
Other
责任方
Sponsor

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