Ethanol Consumption in the Heat

April 11, 2025 updated by: Nicholas Ravanelli, Lakehead University

Evaluating How Alcohol Impacts Physiological Responses and Perception During Heat Exposure

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.

Study Overview

Status

Recruiting

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ontario
      • Thunder Bay, Ontario, Canada, P7B 5E1
        • Recruiting
        • Lakehead University
        • Contact:
        • Contact:
          • KarLee Lefebvre, BHK
        • Contact:
          • Amy Brough, BHK
        • Contact:
          • Taryn Klarner, BHK
        • Contact:
          • Nathan Morris, PhD
        • Contact:
          • Georgia Chaseling, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo (non-alcoholic 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).
Active Comparator: Alcohol
Consumption of alcohol beverages: females 0.75 ± 0.1 grams of ethanol/kilogram body mass; males 1.0 ± 0.1 grams of ethanol/kilogram body mass
Participants rest in a climate controlled room maintained at 40°C and 30%RH for 120 minutes follow alcoholic beverage consumption (180 minutes total).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
3-lead electrocardiogram
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).
Mean skin (4 sites)
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).
measured rectally
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).
ECG-gated blood pressure cuff
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).
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).
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.
Difference in mass from baseline to end heat stress
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).
The total movement of the body around the center of mass with feet together
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).
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
Total urine output (e.g. volume) from baseline to immediately following 120 minutes of heat stress
ASHRAE seven-point thermal sensation scale
Time Frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
5-Point Thermal Comfort Scale
Time Frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Thermal comfort scale with 1- comfortable and 5 - very uncomfortable
measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Visual analog scale with left and right anchors of 0.0 and 0.20, respectively, with markers every 0.005 increment
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).
Measured using a police grade portable breathalyzer
measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared on the Open Science Framework following publication of results

IPD Sharing Access Criteria

Anyone will have access

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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