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Diphenhydramine and Sweating (BENEXE2022)

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Placebo

Diphenhydramine

About this trial

This is an interventional treatment trial for Diphenhydramine Causing Adverse Effects in Therapeutic Use focused on measuring thermoregulation, diphenhydramine, anticholinergic, sweating

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Lakehead Unviersity

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Intervention Order (Placebo - Diphenhydramine)

Intervention Order (Diphenhydramine -Placebo)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in rectal temperature

Change in rectal temperature from pre- to post- exercise using a pediatric grade thermistor

Full Information

NCT ID

NCT05586477

First Posted

October 14, 2022

Last Updated

September 11, 2023

Sponsor

Lakehead University

1. Study Identification

Unique Protocol Identification Number

NCT05586477

Brief Title

Diphenhydramine and Sweating

Acronym

BENEXE2022

Official Title

Does Diphenhydramine Alter Thermoregulatory Responses During Exercise?

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

November 21, 2022 (Actual)

Primary Completion Date

June 23, 2023 (Actual)

Study Completion Date

June 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lakehead University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

thermoregulation, diphenhydramine, anticholinergic, sweating

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Masking Description

Double-blind

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Order (Placebo - Diphenhydramine)

Arm Type

Other

Arm Description

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

Arm Title

Intervention Order (Diphenhydramine -Placebo)

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Diphenhydramine

Intervention Description

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

Primary Outcome Measure Information:

Title

Whole body sweat loss

Description

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.

Time Frame

Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days

Secondary Outcome Measure Information:

Title

Change in rectal temperature

Description

Change in rectal temperature from pre- to post- exercise using a pediatric grade thermistor

Time Frame

Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Ravanelli, PhD

Organizational Affiliation

Lakehead University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lakehead Unviersity

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 5E1

Country

Canada

12. IPD Sharing Statement

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Diphenhydramine and Sweating

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