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Diphenhydramine and Sweating

Does Diphenhydramine Alter Thermoregulatory Responses During Exercise?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05586477
Acronym
BENEXE2022
Enrollment
20
Registered
2022-10-19
Start date
2022-11-21
Completion date
2023-06-23
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Diphenhydramine Causing Adverse Effects in Therapeutic Use, Hyperthermia, Sweating

Keywords

thermoregulation, diphenhydramine, anticholinergic, sweating

Brief 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.

Interventions

DRUGPlacebo

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

DRUGDiphenhydramine

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

Sponsors

Lakehead University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Double-blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Whole body sweat lossMeasured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 daysChange in body mass from pre- to post-exercise corrected for respiratory and metabolic water losses using a digital platform scale accurate to +/- 2 grams.

Secondary

MeasureTime frameDescription
Change in rectal temperatureMeasured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 daysChange in rectal temperature from pre- to post- exercise using a pediatric grade thermistor

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026