Does Diphenhydramine Alter Thermoregulatory Responses During Exercise?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Whole body sweat loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Placebo (Drug)
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
干预措施: Diphenhydramine (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Whole body sweat loss
时间窗: Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days
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.
次要结局
- Change in rectal temperature(Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days)