ClinicalTrials.gg
CompletedNCT06935045Updated Sep 24, 2026

Ethanol Consumption in the Heat

An interventional study of Placebo Beverage and Alcohol (Ethanol) in Alcohol Consumption, Heat Stress and Age, sponsored by Lakehead University. Completed at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Primary conditionAlcohol Drinking(the registry's first term)UnverifiedIs this wrong?Alcohol Drinking is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Lakehead University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Dec 2023, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Consumption
  • Heat Stress
  • Age

Browse trials for

Keywords

  • alcohol
  • heat stress
  • heat wave
  • sweating
  • core temperature
  • micturition
  • perception
  • behaviour
03

In context

Alcohol Drinking Unverified

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's enrollment of 28 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Lakehead University is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or Female above the age of 19
  • Able to provide

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo (non-alcoholic beverage)

    Drug: Placebo Beverage

  • 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)

Interventions

  • DrugPlacebo 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).

  • Participants rest in a climate controlled room maintained at 40°C and 30%RH for 120 minutes follow alcoholic beverage consumption (180 minutes total).

06

What researchers measure

Primary outcomes

  1. Heart Rate

    3-lead electrocardiogram

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  2. Skin Temperature

    Mean skin (4 sites)

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  3. Core Temperature

    measured rectally

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  4. Blood Pressure

    ECG-gated blood pressure cuff

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  5. Heart Rate Variability

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  6. Arrythmia presence

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  7. Whole-body Sweat Loss

    Difference in mass from baseline to end heat stress

    Time frame: mass measured at baseline and end heat stress.

  8. Postural Sway via the Romberg Test

    The total movement of the body around the center of mass with feet together

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  9. Skin Blood Flow

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  10. Urine Output

    Time frame: Total urine output (e.g. volume) from baseline to immediately following 120 minutes of heat stress

  11. ASHRAE seven-point thermal sensation scale

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  12. 5-Point Thermal Comfort Scale

    Thermal comfort scale with 1- comfortable and 5 - very uncomfortable

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Secondary outcomes

  1. 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

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

  2. Blood Alcohol Concentration

    Measured using a police grade portable breathalyzer

    Time frame: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

07

Study locations

1 site
  • Lakehead University
    Thunder Bay, Ontario P7B 5E1, Canada
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Deidentified data will be shared on the Open Science Framework following publication of results

Access criteria: Anyone will have access

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2023 to primary completion in Apr 2025, 16 months.

Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 16 months is below that.

Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2025
First posted
Apr 18, 2025
StartActual
Dec 4, 2023
Primary completionActual
Apr 28, 2025
CompletionActual
Apr 30, 2025
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06935045
Lead sponsor
Lakehead University
Responsible party
Nicholas Ravanelli (Assistant Professor, Lakehead University) — Principal investigator
First posted
Apr 18, 2025
Start date
Dec 4, 2023
Primary completion
Apr 28, 2025
Completion
Apr 30, 2025
Last update
Sep 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ethanol

Start the discussion