Diphenhydramine and Sweating

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2023-06-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Diphenhydramine Causing Adverse Effects in Therapeutic Use Hyperthermia Allergic Rhinitis Sweating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Double-blind

Study Groups

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Intervention Order (Placebo - Diphenhydramine)

On separate days, participants will march on a treadmill for 60 minutes at a fixed rate of oxygen consumption (\~1.75 liters of oxygen consumption per minute) in \~28°C and 30% relative humidity

Group Type OTHER

Placebo

Intervention Type DRUG

A placebo pill (i.e., sugar) will be consumed 2 h before intervention.

Diphenhydramine

Intervention Type DRUG

Extra strength Benadryl (DIN 02470144) will be consumed 2 h before intervention

Intervention Order (Diphenhydramine -Placebo)

On separate days, participants will march on a treadmill for 60 minutes at a fixed rate of oxygen consumption (\~1.75 liters of oxygen consumption per minute) in \~28°C and 30% relative humidity

Group Type OTHER

Placebo

Intervention Type DRUG

A placebo pill (i.e., sugar) will be consumed 2 h before intervention.

Diphenhydramine

Intervention Type DRUG

Extra strength Benadryl (DIN 02470144) will be consumed 2 h before intervention

Interventions

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Placebo

A placebo pill (i.e., sugar) will be consumed 2 h before intervention.

Intervention Type DRUG

Diphenhydramine

Extra strength Benadryl (DIN 02470144) will be consumed 2 h before intervention

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes