HistamineNCT06152497
The Role of Histamine in Muscle Protein Synthesis Following Resistance Training
A study testing H1 blockade: Telfast: 180mg Fexofenadine and Resistance training in people with Histamine, run by University Ghent at 1 site in Belgium.
Trial summary
Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses the following research question: "What is the influence of histamine H1 signaling on training adaptations following ten weeks of resistance training in human skeletal muscle." Results from this study will… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Histamine
- What is being tested?
- H1 blockade: Telfast: 180mg Fexofenadine and Resistance training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-45 years
- Not to medium physically active
Who cannot join
- Smoking
- Chronic disease
- High blood pressure
- Supplement or medication intake
- Seasonal allergies
- Vegetarian / vegan
- Resistance trained
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Department of movement and sports sciences, Ghent University, Belgium
Ghent, Oost-Vlaanderen, 9000
Wim Derave, Professor, 92646326 ext. +32, wim.derave@ugent.be
About this study
Official title: The Role of Histamine in Muscle Protein Synthesis Following Chronic Resistance Training
Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses the following research question: "What is the influence of histamine H1 signaling on training adaptations following ten weeks of resistance training in human skeletal muscle." Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.
- Conditions
- Histamine
- Being tested
- Placebo, H1 blockade: Telfast: 180mg Fexofenadine, Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral placebo
H1 blockade: Telfast: 180mg FexofenadineDrug
H1 blockade: oral blockade with 180mg Fexofenadine
Resistance trainingBehavioural
Resistance training: lower body exercise
| Study group | Role | What they receive |
|---|---|---|
| 1: Placebo | Placebo comparator | Lactose Receives: Drug: Placebo; Behavioral: Resistance training |
| H1 blockade: Telfast (180mg Fexofenadine) | Experimental | H1: Telfast (180mg Fexofenadine) Receives: Drug: H1 blockade: Telfast: 180mg Fexofenadine; Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle volume
Change in muscle volume
Measured: Before and after the 10 weeks of resistance training
Maximal dynamic strength of leg press, bench press, bicep curl and leg curl
Change in maximal dynamic strength of leg press, bench press, bicep curl and leg curl
Measured: Before and after the 10 weeks of resistance training
Muscle fiber hypertrophy in muscle biopsies
Change in muscle fiber hypertrophy in muscle biopsies
Measured: Before and after the 10 weeks of resistance training
Matsuda index, to estimate whole body glucose metabolism, will be calculated using an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood will be measured before and after drinking 75g glucose)
Change in Matsuda index, to estimate whole body glucose metabolism, will be calculated using an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood will be measured before and after drinking 75g glucose)
Measured: Before and after the 10 weeks of resistance training
Vascular function measured with a single passive leg movement (sPLM: change in femoral blood flow measured with Doppler ultrasound before and after one passive flexion/extension of the leg)
Change in vascular function with a single passive leg movement (sPLM: change in femoral blood flow measured with Doppler ultrasound before and after one passive flexion/extension of the leg)
Measured: Before and after the 10 weeks of resistance training
Secondary outcomes (2)
Blood pressure (systolic and diastolic)
Chance in Blood pressure (systolic and diastolic)
Measured: Before and after the 10 weeks of resistance training
Resting heart rate
Chance in Resting heart rate
Measured: Before and after the 10 weeks of resistance training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistamineStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Wim Derave, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152497
- Sponsor's protocol ID
- MPSH - ONZ-2023-0027
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Histamine in Muscle Protein Synthesis Following Chronic Resistance Training
- ClinicalTrials.gov ID
- NCT06152497
- Acronym / sponsor ID
- MPSH - ONZ-2023-0027
- Conditions
- Histamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses the following research question: "What is the influence of histamine H1 signaling on training adaptations following ten weeks of resistance training in human skeletal muscle." Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel groups
| Arm | Type | Receives |
|---|---|---|
| 1: Placebo | Placebo comparator | Drug: Placebo, Behavioral: Resistance trainingLactose |
| H1 blockade: Telfast (180mg Fexofenadine) | Experimental | Drug: H1 blockade: Telfast: 180mg Fexofenadine, Behavioral: Resistance trainingH1: Telfast (180mg Fexofenadine) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18-45 years
- Not to medium physically active
Key exclusion criteria (7 listed)
- Smoking
- Chronic disease
- High blood pressure
- Supplement or medication intake
- Seasonal allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral placebo | Drug | 1: Placebo |
| H1 blockade: Telfast: 180mg FexofenadineH1 blockade: oral blockade with 180mg Fexofenadine | Drug | H1 blockade: Telfast (180mg Fexofenadine) |
| Resistance trainingResistance training: lower body exercise | Behavioural | 1: Placebo, H1 blockade: Telfast (180mg Fexofenadine) |
Primary outcome
Muscle volume
Time frame: Before and after the 10 weeks of resistance training
Change in muscle volume
Maximal dynamic strength of leg press, bench press, bicep curl and leg curl
Time frame: Before and after the 10 weeks of resistance training
Change in maximal dynamic strength of leg press, bench press, bicep curl and leg curl
Muscle fiber hypertrophy in muscle biopsies
Time frame: Before and after the 10 weeks of resistance training
Change in muscle fiber hypertrophy in muscle biopsies
Matsuda index, to estimate whole body glucose metabolism, will be calculated using an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood will be measured before and after drinking 75g glucose)
Time frame: Before and after the 10 weeks of resistance training
Change in Matsuda index, to estimate whole body glucose metabolism, will be calculated using an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood will be measured before and after drinking 75g glucose)
Vascular function measured with a single passive leg movement (sPLM: change in femoral blood flow measured with Doppler ultrasound before and after one passive flexion/extension of the leg)
Time frame: Before and after the 10 weeks of resistance training
Change in vascular function with a single passive leg movement (sPLM: change in femoral blood flow measured with Doppler ultrasound before and after one passive flexion/extension of the leg)
2 secondary outcomes
Blood pressure (systolic and diastolic)
Time frame: Before and after the 10 weeks of resistance training
Resting heart rate
Time frame: Before and after the 10 weeks of resistance training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wim Derave, Professor principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H1 blockade: Telfast: 180mg Fexofenadine and Resistance training in people with Histamine, 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wim Derave, Professor (92646326 ext. +32, wim.derave@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle volume (time frame: Before and after the 10 weeks of resistance training). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2023.