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NCT Number: NCT04450134

Histamine H1/H2 Receptors and Training Adaptations

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.

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Key information

Conditions

Exercise Training Behavior Motor Activity Physical Activity

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Movement and Sports Sciences, Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sedentary or low levels of physical activity
  • Caucasian

Exclusion criteria

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

Treatment and study plan

Lactose

Other

Placebo: Lactose capsules

Fexofenadine Hydrochloride

Drug

H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride

Famotidine

Drug

H2 receptor antagonist: 40 mg Famotidine

High-Intensity Interval Training (HIIT)

Other

6 weeks HIIT

Primary outcomes

  1. Change in cardiorespiratory fitness

    Time frame: Before, after 3 weeks and after 6 weeks of exercise training

    Change in maximal oxygen uptake during incremental cycling test on cycle ergometer during the 6 week training period

  2. Change in peak aerobic power output

    Time frame: Before, after 3 weeks and after 6 weeks of exercise training

    Change in peak power output during incremental cycling test on cycle ergometer during the 6 week training period

  3. Change in whole-body insulin sensitivity

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in Matsuda index for whole-body insulin sensitivity derived from Oral Glucose Tolerance Test after the 6 week training period

  4. Change in microvascular function

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in microvascular function (Single Passive Leg Movement technique) after the 6 week training period

Secondary outcomes

  1. Change in skeletal muscle capillarization

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in skeletal muscle capillarization (immunohistochemistry) after the 6 week training period

  2. Change in skeletal muscle enzyme activity

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in enzyme activity assessment of markers of relevance for skeletal muscle function after the 6 week training period

  3. Change in skeletal muscle protein content

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in Western Blot assessment of markers of relevance for skeletal muscle function after the 6 week training period

  4. Change in power output at Gas Exchange Threshold (GET)

    Time frame: Before, after 3 weeks and after 6 weeks of exercise training

    Change from baseline in GET during incremental cycling test after the 6 week training period

  5. Change in power output at Respiratory Compensation Point (RCP)

    Time frame: Before, after 3 weeks and after 6 weeks of exercise training

    Change from baseline in RCP during incremental cycling test after the 6 week training period

  6. Change in time to exhaustion performance test

    Time frame: Before, after 3 weeks and after 6 weeks of exercise training

    Change in time to exhaustion test (performed after incremental cycling test) during the 6 week training period

  7. Change in heart rate during submaximal cycling

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in heart rate during submaximal cycling after the 6 week training period

  8. Change in substrate oxidation during submaximal cycling

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in substrate oxidation during submaximal cycling test (estimated via gas exchange data) after the 6 week training period

  9. Change in blood lactate accumulation during submaximal cycling

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in capillary lactate concentration at end of submaximal cycling test after the 6 week training period

  10. Change in cycling efficiency during submaximal cycling

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in cycling efficiency (estimated via gas exchange data) after the 6 week training period

  11. Change in fasted serum insulin concentrations

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in fasted blood concentrations of insulin after the 6 week training period

  12. Change in fasted serum glucose concentrations

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in fasted blood concentrations of glucose after the 6 week training period

  13. Change in fasted serum cholesterol concentrations

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in fasted blood concentrations of cholesterol after the 6 week training period

  14. Change in fasted serum triglyceride concentrations

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in fasted blood concentrations of triglyceride after the 6 week training period

  15. Change in resting blood pressure

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in resting mean arterial blood pressure after the 6 week training period

  16. Change in resting heart rate

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in resting heart rate after the 6 week training period

  17. Change in body weight

    Time frame: Before and after 6 weeks of exercise training

    Change from baseline in total body weight after the 6 week training period

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Research Foundation Flanders
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jun 29, 2020
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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