Histamine H1/H2 Receptors and Training Adaptations

Study Overview
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Brief Summary
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Exercise training is beneficial for both health and performance. Histamine has been shown to be involved in the acute exercise response. The current study addresses the role of histamine H1/H2 receptor signaling in the chronic training-induced adaptations. Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.

Official Title
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Role of Histamine H1/H2 Receptors in the Health- and Performance-promoting Adaptations to High-intensity Interval Training

Conditions
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Exercise Training, Physical Activity

Intervention / Treatment
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* Other: Lactose
* Drug: Fexofenadine Hydrochloride
* Drug: Famotidine
* Other: High-intensity interval training (HIIT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary or low levels of physical activity Caucasian Exclusion Criteria: Chronic diseases Medication use Smoking Excessive alcohol consumption Seasonal allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo + exercise vs histamine blockade + exercise
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>6 weeks high-intensity interval training + placebo intake | Other: Lactose<br>* Placebo: Lactose capsules<br>Other: High-intensity interval training (HIIT)<br>* 6 weeks HIIT<br>|
| Experimental: Blockade<br>6 weeks high-intensity interval training + histamine H1/H2 receptor blockade | Drug: Fexofenadine Hydrochloride<br>* H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride<br>Drug: Famotidine<br>* H2 receptor antagonist: 40 mg Famotidine<br>Other: High-intensity interval training (HIIT)<br>* 6 weeks HIIT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiorespiratory fitness | Change in maximal oxygen uptake during incremental cycling test on cycle ergometer during the 6 week training period | Before, after 3 weeks and after 6 weeks of exercise training | 
| Change in peak aerobic power output | Change in peak power output during incremental cycling test on cycle ergometer during the 6 week training period | Before, after 3 weeks and after 6 weeks of exercise training | 
| Change in whole-body insulin sensitivity | Change from baseline in Matsuda index for whole-body insulin sensitivity derived from Oral Glucose Tolerance Test after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in microvascular function | Change from baseline in microvascular function (Single Passive Leg Movement technique) after the 6 week training period | Before and after 6 weeks of exercise training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skeletal muscle capillarization | Change from baseline in skeletal muscle capillarization (immunohistochemistry) after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in skeletal muscle enzyme activity | Change from baseline in enzyme activity assessment of markers of relevance for skeletal muscle function after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in skeletal muscle protein content | Change from baseline in Western Blot assessment of markers of relevance for skeletal muscle function after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in power output at Gas Exchange Threshold (GET) | Change from baseline in GET during incremental cycling test after the 6 week training period | Before, after 3 weeks and after 6 weeks of exercise training | 
| Change in power output at Respiratory Compensation Point (RCP) | Change from baseline in RCP during incremental cycling test after the 6 week training period | Before, after 3 weeks and after 6 weeks of exercise training | 
| Change in time to exhaustion performance test | Change in time to exhaustion test (performed after incremental cycling test) during the 6 week training period | Before, after 3 weeks and after 6 weeks of exercise training | 
| Change in heart rate during submaximal cycling | Change from baseline in heart rate during submaximal cycling after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in substrate oxidation during submaximal cycling | Change from baseline in substrate oxidation during submaximal cycling test (estimated via gas exchange data) after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in blood lactate accumulation during submaximal cycling | Change from baseline in capillary lactate concentration at end of submaximal cycling test after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in cycling efficiency during submaximal cycling | Change from baseline in cycling efficiency (estimated via gas exchange data) after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in fasted serum insulin concentrations | Change from baseline in fasted blood concentrations of insulin after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in fasted serum glucose concentrations | Change from baseline in fasted blood concentrations of glucose after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in fasted serum cholesterol concentrations | Change from baseline in fasted blood concentrations of cholesterol after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in fasted serum triglyceride concentrations | Change from baseline in fasted blood concentrations of triglyceride after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in resting blood pressure | Change from baseline in resting mean arterial blood pressure after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in resting heart rate | Change from baseline in resting heart rate after the 6 week training period | Before and after 6 weeks of exercise training | 
| Change in body weight | Change from baseline in total body weight after the 6 week training period | Before and after 6 weeks of exercise training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physiology