Ethanol Consumption in the Heat

NCT06935045 | Recruiting

• 1 other identifier: 1469888
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Consumption; Heat Stress; Age

Keywords

alcohol; heat stress; heat wave; sweating; core temperature; micturition; perception; behaviour

Outcome Measures

Primary Outcomes (12)

• Heart Rate

  3-lead electrocardiogram

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

• Skin Temperature

  Mean skin (4 sites)

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

• Core Temperature

  measured rectally

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

• Blood Pressure

  ECG-gated blood pressure cuff

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

• Heart Rate Variability

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

• Arrythmia presence

  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

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

• Skin Blood Flow

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

• Urine Output

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

• ASHRAE seven-point thermal sensation scale

  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 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)

  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).

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (non-alcoholic beverage)

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

Drug: Alcohol (Ethanol)

Interventions

Placebo Beverage DRUG

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

Placebo

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).

Alcohol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lakehead University: lead

Study Sites (1)

Lakehead University

Thunder Bay, Ontario, P7B 5E1, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 39267036 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking; Heat Stress Disorders; Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Nicholas Ravanelli, PhD

CONTACT

18073438010; nravanel@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 18, 2025
• Study Start: December 4, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Anyone will have access

Locations

CA (1)