Clinical trial NCT06935045: Ethanol Consumption in the Heat
Official title: Evaluating How Alcohol Impacts Physiological Responses and Perception During Heat Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Consumption
Heat Stress
Age
Keywords: alcohol
heat stress
heat wave
sweating
core temperature
micturition
perception
behaviour
Lead sponsor: Lakehead University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Heart Rate
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Skin Temperature
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Core Temperature
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Blood Pressure
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Heart Rate Variability
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Arrythmia presence
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Whole-body Sweat Loss
timeFrame: mass measured at baseline and end heat stress.
measure: Postural Sway via the Romberg Test
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Skin Blood Flow
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Urine Output
timeFrame: Total urine output (e.g. volume) from baseline to immediately following 120 minutes of heat stress
measure: ASHRAE seven-point thermal sensation scale
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: 5-Point Thermal Comfort Scale
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Secondary outcomes:
measure: Subjective Blood Alcohol Concentration (visual analog scale 0.0 - 0.20)
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measure: Blood Alcohol Concentration
timeFrame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Lakehead University
state: Ontario
Study officials:
References:
citation: 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.