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Clinical Trials/NCT06935045
NCT06935045CompletedNot Applicable

Evaluating How Alcohol Impacts Physiological Responses and Perception During Heat Exposure

Lakehead University2 sites in 1 country28 target enrollmentStarted: December 4, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
2
Primary Endpoint
Skin Temperature

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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

Intervention: Alcohol (Ethanol) (Drug)

Placebo

Placebo Comparator

Placebo (non-alcoholic beverage)

Intervention: Placebo Beverage (Drug)

Outcomes

Primary Outcomes

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

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

3-lead electrocardiogram

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

Secondary Outcomes

  • Subjective Blood Alcohol Concentration (visual analog scale 0.0 - 0.20)(measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).)
  • Blood Alcohol Concentration(measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nicholas Ravanelli

Assistant Professor

Lakehead University

Study Sites (2)

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