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Exercise TrainingNCT04450134

Histamine H1/H2 Receptors and Training Adaptations

A study testing Lactose, Fexofenadine Hydrochloride and Famotidine in people with Exercise Training and Physical Activity, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Exercise Training, Physical Activity
What is being tested?
Lactose, Fexofenadine Hydrochloride and Famotidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
1 siteBelgium
Study dates
2 Oct 2019to 14 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Sedentary or low levels of physical activity
  • Caucasian

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Department of Movement and Sports Sciences, Ghent University

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

Official title: 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.

Being tested
Lactose, Fexofenadine Hydrochloride, Famotidine, High-intensity interval training (HIIT)
Keywords
Exercise, Physiology
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LactoseOther

    Placebo: Lactose capsules

  • Fexofenadine HydrochlorideDrug

    H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride

  • FamotidineDrug

    H2 receptor antagonist: 40 mg Famotidine

  • High-intensity interval training (HIIT)Other

    6 weeks HIIT

Study groups in NCT04450134
Study groupRoleWhat they receive
PlaceboPlacebo comparator6 weeks high-intensity interval training + placebo intake
Receives: Other: Lactose; Other: High-intensity interval training (HIIT)
BlockadeExperimental6 weeks high-intensity interval training + histamine H1/H2 receptor blockade
Receives: Drug: Fexofenadine Hydrochloride; Drug: Famotidine; Other: High-intensity interval training (HIIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cardiorespiratory fitness

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

    Measured: Before, after 3 weeks and after 6 weeks of exercise training

  2. Change in peak aerobic power output

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

    Measured: Before, after 3 weeks and after 6 weeks of exercise training

  3. 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

    Measured: Before and after 6 weeks of exercise training

  4. Change in microvascular function

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

    Measured: Before and after 6 weeks of exercise training

Secondary outcomes (17)

  1. Change in skeletal muscle capillarization

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

    Measured: Before and after 6 weeks of exercise training

  2. 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

    Measured: Before and after 6 weeks of exercise training

  3. 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

    Measured: Before and after 6 weeks of exercise training

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

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

    Measured: Before, after 3 weeks and after 6 weeks of exercise training

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

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

    Measured: Before, after 3 weeks and after 6 weeks of exercise training

  6. Change in time to exhaustion performance test

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

    Measured: Before, after 3 weeks and after 6 weeks of exercise training

  7. Change in heart rate during submaximal cycling

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

    Measured: Before and after 6 weeks of exercise training

  8. 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

    Measured: Before and after 6 weeks of exercise training

  9. 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

    Measured: Before and after 6 weeks of exercise training

  10. Change in cycling efficiency during submaximal cycling

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

    Measured: Before and after 6 weeks of exercise training

  11. Change in fasted serum insulin concentrations

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

    Measured: Before and after 6 weeks of exercise training

  12. Change in fasted serum glucose concentrations

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

    Measured: Before and after 6 weeks of exercise training

  13. Change in fasted serum cholesterol concentrations

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

    Measured: Before and after 6 weeks of exercise training

  14. Change in fasted serum triglyceride concentrations

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

    Measured: Before and after 6 weeks of exercise training

  15. Change in resting blood pressure

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

    Measured: Before and after 6 weeks of exercise training

  16. Change in resting heart rate

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

    Measured: Before and after 6 weeks of exercise training

  17. Change in body weight

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

    Measured: Before and after 6 weeks of exercise training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2020
  2. Study start2 Oct 2019
  3. Primary completion18 Dec 2019
  4. Study completion14 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Placebo + exercise vs histamine blockade + exercise
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450134
Sponsor's protocol ID
HIST-TRAINING (BC-06009)
Status last verified
Jun 2024
First submitted
9 Jun 2020
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Lactose, Fexofenadine Hydrochloride and Famotidine in people with Exercise Training and Physical Activity, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cardiorespiratory fitness (time frame: Before, after 3 weeks and after 6 weeks of exercise training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04450134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.

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