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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05586477
Other study ID # 2022509
Secondary ID 265937
Status Completed
Phase Phase 4
First received
Last updated
Start date November 21, 2022
Est. completion date June 23, 2023

Study information

Verified date September 2023
Source Lakehead University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In 2012, it was estimated that nearly 1 in 4 Canadians suffer from allergic rhinitis. To add, 78% of individuals working in predisposing environments are predicted to develop occupational rhinitis. Currently, the most popular treatment for rhinitis is antihistamine medication such as diphenhydramine, a first-generation antihistamine sold commercially as Benadryl®. Due it its anticholinergic effects, diphenhydramine has been suggested to impair the whole body sweating response during heat stress, potentially leaving consumers at an increased risk of heat-related illness. This randomized control trial approved by Health Canada will investigate whether ingesting extra strength diphenhydramine (50mg) will alter whole-body sweat losses during 60 minutes of exercise.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 23, 2023
Est. primary completion date June 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Able to safely perform ~60 minutes of moderate intensity exercise - No known hypersensitivity to diphenhydramine - Not on any prescribed medication - Body-mass index (BMI) less than 30 Exclusion Criteria: - Outside 18 - 49 years of age - Diagnosed with any cardiovascular, respiratory, neurological or metabolic disease - History of any cardiovascular, respiratory, neurological or metabolic disease - Unable to exercise for 60 minutes at moderate intensity, or have a musculoskeletal injury - BMI > or = 30

Study Design


Intervention

Drug:
Placebo
A placebo pill (i.e., sugar) will be consumed 2 h before intervention.
Diphenhydramine
Extra strength Benadryl (DIN 02470144) will be consumed 2 h before intervention

Locations

Country Name City State
Canada Lakehead Unviersity Thunder Bay Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lakehead University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole body sweat loss Change in body mass from pre- to post-exercise corrected for respiratory and metabolic water losses using a digital platform scale accurate to +/- 2 grams. Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days
Secondary Change in rectal temperature Change in rectal temperature from pre- to post- exercise using a pediatric grade thermistor Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days
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