Histamine H1/H2 Receptors and Training Adaptations

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450134
• Other study ID #: HIST-TRAINING
• Status: Completed
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: April 14, 2021

Study information

• Verified date: July 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 14, 2021
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Sedentary or low levels of physical activity
• Caucasian

Exclusion Criteria:

• Chronic diseases
• Medication use
• Smoking
• Excessive alcohol consumption
• Seasonal allergies

Related Conditions & MeSH terms

• Exercise Training
• Physical Activity

Intervention

Other:
• Lactose
Placebo: Lactose capsules

Drug:
• Fexofenadine Hydrochloride
H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride
• Famotidine
H2 receptor antagonist: 40 mg Famotidine

Other:
• High-intensity interval training (HIIT)
6 weeks HIIT

Locations

Country	Name	City	State
Belgium	Department of Movement and Sports Sciences, Ghent University	Gent	Oost-Vlaanderen

Sponsors (3)

Lead Sponsor	Collaborator
Wim Derave	Research Foundation Flanders, University of Copenhagen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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