Histamine H1/H2 Receptors and Training Adaptations

June 5, 2024 updated by: University Ghent

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Before, after 3 weeks and after 6 weeks of exercise training
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
Before, after 3 weeks and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before, after 3 weeks and after 6 weeks of exercise training
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
Before, after 3 weeks and after 6 weeks of exercise training
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
Before, after 3 weeks and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training
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
Before and after 6 weeks of exercise training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Research Foundation Flanders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIST-TRAINING (BC-06009)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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