Histamine H1/H2 Receptors and Training Adaptations

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Exercise Training
• Intervention / Treatment: Other: Lactose; Other: High-intensity interval training (HIIT); Drug: Fexofenadine Hydrochloride; Drug: Famotidine

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Department of Movement and Sports Sciences, Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Sedentary or low levels of physical activity
• Caucasian

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; 6 weeks high-intensity interval training + placebo intake	Other: Lactose; Placebo: Lactose capsules; Other: High-intensity interval training (HIIT); 6 weeks HIIT
EXPERIMENTAL: Blockade; 6 weeks high-intensity interval training + histamine H1/H2 receptor blockade	Other: High-intensity interval training (HIIT); 6 weeks HIIT; Drug: Fexofenadine Hydrochloride; H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride; Drug: Famotidine; H2 receptor antagonist: 40 mg Famotidine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wim Derave
• Collaborators: University of Copenhagen; Research Foundation Flanders

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2019
• Primary Completion (ACTUAL): December 18, 2019
• Study Completion (ACTUAL): April 14, 2021

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (ACTUAL): June 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Physiology
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H2 Antagonists; Famotidine; Fexofenadine
• Other Study ID Numbers: HIST-TRAINING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No