- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06935045
Ethanolforbrug i varmen
Evaluering af, hvordan alkohol påvirker fysiologiske reaktioner og opfattelsen under varmeeksponering
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Ontario
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Thunder Bay, Ontario, Canada, P7B 5E1
- Lakehead University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: 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). |
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Aktiv komparator: 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pulsvariabilitet
Tidsramme: målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
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målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
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Arrythmia tilstedeværelse
Tidsramme: målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
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målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
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Hudblodstrøm
Tidsramme: målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
|
målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
|
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Urinudgang
Tidsramme: Samlet urinudgang (f.eks. Volumen) fra baseline til umiddelbart efter 120 minutters varmestress
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Samlet urinudgang (f.eks. Volumen) fra baseline til umiddelbart efter 120 minutters varmestress
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ASHRAE syv-punkts termisk sensationsskala
Tidsramme: målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
|
målt ved baseline (før drink) og hvert 30. minut efter forbruget (op til 120 minutter).
|
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Heart Rate
Tidsramme: 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).
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Skin Temperature
Tidsramme: 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).
|
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Core Temperature
Tidsramme: 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).
|
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Blood Pressure
Tidsramme: 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).
|
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Whole-body Sweat Loss
Tidsramme: mass measured at baseline and end heat stress.
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Difference in mass from baseline to end heat stress |
mass measured at baseline and end heat stress.
|
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Postural Sway via the Romberg Test
Tidsramme: 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).
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5-Point Thermal Comfort Scale
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Blood Alcohol Concentration (visual analog scale 0.0 - 0.20)
Tidsramme: 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).
|
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Blood Alcohol Concentration
Tidsramme: 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).
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1469888
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Deidentified data will be shared on the Open Science Framework following publication of results
IPD-delingsadgangskriterier
Anyone will have access
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