Alcohol ConsumptionNCT06935045
Ethanol Consumption in the Heat
A study testing Alcohol (Ethanol) in people with Alcohol Consumption and Heat Stress, run by Lakehead University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Heat Stress, Age
- What is being tested?
- Alcohol (Ethanol)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female above the age of 19
- Able to provide informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Consumption, Heat Stress, Age
- Being tested
- Placebo Beverage, Alcohol (Ethanol)
- Keywords
- alcohol, heat stress, heat wave, sweating, core temperature, micturition, perception, behaviour
- Medical subject headings
- Alcohol Drinking, Heat Stress Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo BeverageDrug
Participants rest in a climate controlled room maintained at 40°C and 30%RH for 120 minutes follow placebo beverage consumption (180 minutes total).
Alcohol (Ethanol)Drug
Participants rest in a climate controlled room maintained at 40°C and 30%RH for 120 minutes follow alcoholic beverage consumption (180 minutes total).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (non-alcoholic beverage) Receives: Drug: Placebo Beverage |
| Alcohol | Active comparator | 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 Receives: Drug: Alcohol (Ethanol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
3-lead electrocardiogram
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Skin Temperature
Mean skin (4 sites)
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Core Temperature
measured rectally
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Blood Pressure
ECG-gated blood pressure cuff
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Heart Rate Variability
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Arrythmia presence
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Whole-body Sweat Loss
Difference in mass from baseline to end heat stress
Measured: mass measured at baseline and end heat stress.
Postural Sway via the Romberg Test
The total movement of the body around the center of mass with feet together
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Skin Blood Flow
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Urine Output
Measured: Total urine output (e.g. volume) from baseline to immediately following 120 minutes of heat stress
ASHRAE seven-point thermal sensation scale
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
5-Point Thermal Comfort Scale
Thermal comfort scale with 1- comfortable and 5 - very uncomfortable
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Secondary outcomes (2)
Subjective Blood Alcohol Concentration (visual analog scale 0.0 - 0.20)
Visual analog scale with left and right anchors of 0.0 and 0.20, respectively, with markers every 0.005 increment
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Blood Alcohol Concentration
Measured using a police grade portable breathalyzer
Measured: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start4 Dec 2023
- Primary completion28 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Ravanelli, Lakehead University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935045
- Sponsor's protocol ID
- 1469888
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared on the Open Science Framework following publication of results
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.
PubMed 39267036
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating How Alcohol Impacts Physiological Responses and Perception During Heat Exposure
- ClinicalTrials.gov ID
- NCT06935045
- Acronym / sponsor ID
- 1469888
- Conditions
- Alcohol Consumption, Heat Stress, Age
- Keywords
- alcohol, heat stress, heat wave, sweating, core temperature, micturition, perception, behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo BeveragePlacebo (non-alcoholic beverage) |
| Alcohol | Active comparator | Drug: Alcohol (Ethanol)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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female above the age of 19
- Able to provide informed consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo BeverageParticipants rest in a climate controlled room maintained at 40°C and 30%RH for 120 minutes follow placebo beverage consumption (180 minutes total). | Drug | Placebo |
| 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). | Drug | Alcohol |
Primary outcome
Heart Rate
Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
3-lead electrocardiogram
Skin Temperature
Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
Mean skin (4 sites)
Core Temperature
Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
measured rectally
Blood Pressure
Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).
ECG-gated blood pressure cuff
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.
Difference in mass from baseline to 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
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
ASHRAE seven-point thermal sensation scale
Time frame: 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
2 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 39267036Morris 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.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared on the Open Science Framework following publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol (Ethanol) in people with Alcohol Consumption and Heat Stress, run by Lakehead University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06935045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.