Histamine H1/H2 Receptors and Training Adaptations

Overview

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.

Full Title of Study: “Role of Histamine H1/H2 Receptors in the Health- and Performance-promoting Adaptations to High-intensity Interval Training”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 18, 2019

Interventions

  • Other: Lactose
    • Placebo: Lactose capsules
  • Drug: Fexofenadine Hydrochloride
    • H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride
  • Drug: Famotidine
    • H2 receptor antagonist: 40 mg Famotidine
  • Other: High-intensity interval training (HIIT)
    • 6 weeks HIIT

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • 6 weeks high-intensity interval training + placebo intake
  • Experimental: Blockade
    • 6 weeks high-intensity interval training + histamine H1/H2 receptor blockade

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Sedentary or low levels of physical activity
  • Caucasian

Exclusion Criteria

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wim Derave
  • Collaborator
    • Research Foundation Flanders
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Wim Derave, Professor – University Ghent

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