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Recruiting NCT06935045

Ethanol Consumption in the Heat

No phase Interventional Alcohol Consumption Heat Stress Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo Beverage, Alcohol (Ethanol).
Who it may be relevant to
Registry conditions: Alcohol Consumption, Heat Stress, Age. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating How Alcohol Impacts Physiological Responses and Perception During Heat Exposure

Overview

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.

Interventions

  • Drug 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).
  • Drug 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).

Primary outcome measures

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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Canada · 1 center
  • Lakehead University — Thunder Bay

Publications

  • 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

Identifiers

NCT: NCT06935045 · 1469888

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗