Diphenhydramine and Sweating

Allergic Rhinitis Clinical Trial

— BENEXE2022  

Official title:

Does Diphenhydramine Alter Thermoregulatory Responses During Exercise?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586477
• Other study ID #: 2022509
• Secondary ID: 265937
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Hyperthermia
• Rhinitis
• Rhinitis, Allergic
• Sweating

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