- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06935045
Ethanol Consumption in the Heat
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicholas Ravanelli, PhD
- Phone Number: 18073438010
- Email: nravanel@nus.edu.sg
Study Locations
-
-
Ontario
-
Thunder Bay, Ontario, Canada, P7B 5E1
- Recruiting
- Lakehead University
-
Contact:
- Nicholas Ravanelli, PhD
- Phone Number: 8073438010
- Email: nravanel@nus.edu.sg
-
Contact:
- KarLee Lefebvre, BHK
-
Contact:
- Amy Brough, BHK
-
Contact:
- Taryn Klarner, BHK
-
Contact:
- Nathan Morris, PhD
-
Contact:
- Georgia Chaseling, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1469888
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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