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Идёт набор NCT06935045

Ethanol Consumption in the Heat

Без фазы С лечением Alcohol Consumption Heat Stress Age

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Placebo Beverage, Alcohol (Ethanol).
Кому может быть актуально
Состояния в реестре: Alcohol Consumption, Heat Stress, Age. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Evaluating How Alcohol Impacts Physiological Responses and Perception During Heat Exposure

Обзор

Climate change has significantly increased the earth's average surface temperature and heat waves have been predicted to increase in frequency, intensity and duration. Extreme heat events have increased the susceptibility to heat-related illnesses, such as heat exhaustion, heat stroke or death. Heat health action plans have been designed to advertise cooling behaviours to mitigate physiological strain. Heat health action plans suggest avoiding alcohol consumption during extreme heat as it may increase dehydration and impair behavioural or physiological temperature regulation and thermal perception. Regardless of these messages, alcohol sales continue to remain high during the summer months year after year, and 1/5 of adults identify alcohol as a hydration strategy during extreme heat events. A recent scoping review investigating the effects of alcohol and heat has demonstrated that acute alcohol consumption does not negatively influence thermoregulation, hydration, or hormone markers of fluid balance in the heat compared to a control fluid (https://doi.org/10.1186/s12940-024-01113-y). Further, alcohol consumption may elicit sex- and age-specific alterations in physiological and perceptual responses, neither of which have been explored. Therefore, this study aims to comprehensively evaluate how alcohol consumption systematically alters physiological responses and perceptions during conditions similar to those experienced indoors during extreme heat events in younger and older adults.

Вмешательства

  • Препарат Placebo Beverage
    Participants rest in a climate controlled room maintained at 40°C and 30%RH for 120 minutes follow placebo beverage consumption (180 minutes total).
  • Препарат Alcohol (Ethanol)
    Participants rest in a climate controlled room maintained at 40°C and 30%RH for 120 minutes follow alcoholic beverage consumption (180 minutes total).

Первичные конечные точки

  • Heart Rate [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Skin Temperature [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Core Temperature [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Blood Pressure [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Heart Rate Variability [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Arrythmia presence [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Whole-body Sweat Loss [Срок оценки: mass measured at baseline and end heat stress.]
  • Postural Sway via the Romberg Test [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Skin Blood Flow [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Urine Output [Срок оценки: Total urine output (e.g. volume) from baseline to immediately following 120 minutes of heat stress]
Вторичные конечные точки (2)
  • Subjective Blood Alcohol Concentration (visual analog scale 0.0 - 0.20) [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]
  • Blood Alcohol Concentration [Срок оценки: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).]

Критерии участия

Критерии включения

  • Male or Female above the age of 19
  • Able to provide informed consent

Критерии исключения

  • History of cardiovascular disease, cancer, type 1 or 2 diabetes, chronic obstructive pulmonary disorder, cystic fibrosis, or alcohol addiction or dependence
  • Been hospitalized due to COVID-19
  • Pregnant/Breastfeeding
  • Scoring an eight or above on the Alcohol Use Disorders Identification Test (AUDIT)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • Lakehead University — Thunder Bay

Публикации

  • Morris NB, Ravanelli N, Chaseling GK. The effect of alcohol consumption on human physiological and perceptual responses to heat stress: a systematic scoping review. Environ Health. 2024 Sep 12;23(1):73. doi: 10.1186/s12940-024-01113-y. PMID 39267036

Идентификаторы

NCT: NCT06935045 · 1469888

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗