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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo (non-alcoholic beverage)
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).
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lakehead University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1469888

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings