ExerciseNCT05131555
Influence of Endurance Exercise and Histamine Receptors on the Gene Expression in Skeletal Muscle
A study testing H1 blockade: H1 receptor antagonist + exercise training and H2 Blockade: H2 receptor antagonist + exercise training in people with Exercise and 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 a twofold research question: "What is the influence of endurance training (1) and histamine H1 and H2 signaling (2) on the gene expression in human skeletal muscle." Results from this study will yield more… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- H1 blockade: H1 receptor antagonist + exercise training and H2 Blockade: H2 receptor antagonist + exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Aug 2021to 31 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female
- 18-45 years
- not to medium physically active
Who cannot join
- Smoking
- Chronic disease
- Supplement or medication intake
- Seasonal allergies
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of movement and sports sciences, Ghent University, Belgium
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Influence of Endurance Training and Histamine Receptor Antagonists on the Transcriptome Response in Human Muscle
Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses a twofold research question: "What is the influence of endurance training (1) and histamine H1 and H2 signaling (2) on the gene expression in human skeletal muscle." Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.
- Being tested
- Placebo: Placebo + exercise training., H1 blockade: H1 receptor antagonist + exercise training, H2 Blockade: H2 receptor antagonist + exercise training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo: Placebo + exercise training.Drug
Oral placebo Exercise training: Interval-based cycling exercise
H1 blockade: H1 receptor antagonist + exercise trainingDrug
H1 blockade: oral blockade Exercise training: Interval-based cycling exercise
H2 Blockade: H2 receptor antagonist + exercise trainingDrug
H2 blockade: oral blockade Exercise training: Interval-based cycling exercise
| Study group | Role | What they receive |
|---|---|---|
| 1: Placebo | Placebo comparator | lactose Receives: Drug: Placebo: Placebo + exercise training. |
| H1 blockade | Experimental | 540 mg Fexofenadine Receives: Drug: H1 blockade: H1 receptor antagonist + exercise training |
| H2 blockade | Experimental | 40 mg Famotidine Receives: Drug: H2 Blockade: H2 receptor antagonist + exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle transcriptome (direct response)
RNA-sequencing
Measured: On each test-day: 0 minutes after the exercise training versus at rest.
Change in muscle transcriptome (delayed response)
RNA-sequencing
Measured: On each test-day: 180 minutes after the exercise training versus at rest.
Muscle glycogen depletion
Fluorometric determination of muscle glycogen levels
Measured: On each test-day: 0 minutes after the exercise training versus at rest.
Muscle glycogen resynthesis
Fluorometric determination of muscle glycogen levels
Measured: On each test-day: 180 minutes after the exercise training versus at rest.
Plasma volume change
Plasma volume based on hemoglobin and hematocrit concentration.
Measured: Change from rest to different time-points after exercise (0, 30, 60, 120 and 180 minutes after the exercise training).
Secondary outcomes (6)
Heart rate during the exercise training
Heart rate during the exercise training.
Measured: Continuously during training on each test-day.
Blood lactate
Capillary lactate concentration.
Measured: On each test-day at 10 time-points: at rest, during exercise and 0, 30, 60, 120 and 180 minutes after the exercise training.
Blood glucose
Capillary glucose concentration.
Measured: On each test-day at 10 time-points: at rest, during exercise and 0, 30, 60, 120 and 180 minutes after the exercise training.
Blood histamine
histamine concentration in blood samples.
Measured: On each test-day at 6 time-points: at rest and 0, 30, 60, 120 and 180 minutes after the exercise training.
Blood insulin
insulin concentration in blood samples.
Measured: On each test-day at 6 time-points: at rest and 0, 30, 60, 120 and 180 minutes after the exercise training.
Muscle signaling pathways relevant for glucose metabolism and cardiovascular health
Phosphorylation status of proteins assessed by Western Blotting
Measured: On each test-day: at rest, 0 minutes and 180 minutes after the exercise training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start16 Aug 2021
- Primary completion6 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Crossover
- Model description
- Randomized double-blinded placebo-controlled cross-over interventional study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
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
- NCT05131555
- Sponsor's protocol ID
- AET - BC-10237
- Status last verified
- Apr 2024
- First submitted
- 15 Oct 2021
- Last updated
- 12 Apr 2024
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Endurance Training and Histamine Receptor Antagonists on the Transcriptome Response in Human Muscle
- ClinicalTrials.gov ID
- NCT05131555
- Acronym / sponsor ID
- AET - BC-10237
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Nov 2021 (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 a twofold research question: "What is the influence of endurance training (1) and histamine H1 and H2 signaling (2) on the gene expression 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
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized double-blinded placebo-controlled cross-over interventional study
| Arm | Type | Receives |
|---|---|---|
| 1: Placebo | Placebo comparator | Drug: Placebo: Placebo + exercise training.lactose |
| H1 blockade | Experimental | Drug: H1 blockade: H1 receptor antagonist + exercise training540 mg Fexofenadine |
| H2 blockade | Experimental | Drug: H2 Blockade: H2 receptor antagonist + exercise training40 mg Famotidine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female
- 18-45 years
- not to medium physically active
Key exclusion criteria (4 listed)
- Smoking
- Chronic disease
- 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 |
|---|---|---|
| Placebo: Placebo + exercise training.Oral placebo Exercise training: Interval-based cycling exercise | Drug | 1: Placebo |
| H1 blockade: H1 receptor antagonist + exercise trainingH1 blockade: oral blockade Exercise training: Interval-based cycling exercise | Drug | H1 blockade |
| H2 Blockade: H2 receptor antagonist + exercise trainingH2 blockade: oral blockade Exercise training: Interval-based cycling exercise | Drug | H2 blockade |
Primary outcome
Change in muscle transcriptome (direct response)
Time frame: On each test-day: 0 minutes after the exercise training versus at rest.
RNA-sequencing
Change in muscle transcriptome (delayed response)
Time frame: On each test-day: 180 minutes after the exercise training versus at rest.
RNA-sequencing
Muscle glycogen depletion
Time frame: On each test-day: 0 minutes after the exercise training versus at rest.
Fluorometric determination of muscle glycogen levels
Muscle glycogen resynthesis
Time frame: On each test-day: 180 minutes after the exercise training versus at rest.
Fluorometric determination of muscle glycogen levels
Plasma volume change
Time frame: Change from rest to different time-points after exercise (0, 30, 60, 120 and 180 minutes after the exercise training).
Plasma volume based on hemoglobin and hematocrit concentration.
6 secondary outcomes
Heart rate during the exercise training
Time frame: Continuously during training on each test-day.
Blood lactate
Time frame: On each test-day at 10 time-points: at rest, during exercise and 0, 30, 60, 120 and 180 minutes after the exercise training.
Blood glucose
Time frame: On each test-day at 10 time-points: at rest, during exercise and 0, 30, 60, 120 and 180 minutes after the exercise training.
Blood histamine
Time frame: On each test-day at 6 time-points: at rest and 0, 30, 60, 120 and 180 minutes after the exercise training.
Blood insulin
Time frame: On each test-day at 6 time-points: at rest and 0, 30, 60, 120 and 180 minutes after the exercise training.
Muscle signaling pathways relevant for glucose metabolism and cardiovascular health
Time frame: On each test-day: at rest, 0 minutes and 180 minutes after the exercise training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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. This study is not recruiting at the moment.
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: H1 receptor antagonist + exercise training and H2 Blockade: H2 receptor antagonist + exercise training in people with Exercise and 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 4 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 12 Apr 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 muscle transcriptome (direct response) (time frame: On each test-day: 0 minutes after the exercise training versus at rest.). 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 12 Apr 2024.