- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05131555
Influence of Endurance Exercise and Histamine Receptors on the Gene Expression in Skeletal Muscle
April 11, 2024 updated by: University Ghent
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
14
Phase
- 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
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgium, 9000
- Department of movement and sports sciences, Ghent University, Belgium
-
-
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
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male and female
- 18-45 years
- not to medium physically active
Exclusion Criteria:
- Smoking
- Chronic disease
- Supplement or medication intake
- 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: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 1: Placebo
lactose
|
Oral placebo Exercise training: Interval-based cycling exercise
|
|
Experimental: H1 blockade
540 mg Fexofenadine
|
H1 blockade: oral blockade Exercise training: Interval-based cycling exercise
|
|
Experimental: H2 blockade
40 mg Famotidine
|
H2 blockade: oral blockade Exercise training: Interval-based cycling exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in muscle transcriptome (direct response)
Time Frame: On each test-day: 0 minutes after the exercise training versus at rest.
|
RNA-sequencing
|
On each test-day: 0 minutes after the exercise training versus at rest.
|
|
Change in muscle transcriptome (delayed response)
Time Frame: On each test-day: 180 minutes after the exercise training versus at rest.
|
RNA-sequencing
|
On each test-day: 180 minutes after the exercise training versus at rest.
|
|
Muscle glycogen depletion
Time Frame: On each test-day: 0 minutes after the exercise training versus at rest.
|
Fluorometric determination of muscle glycogen levels
|
On each test-day: 0 minutes after the exercise training versus at rest.
|
|
Muscle glycogen resynthesis
Time Frame: On each test-day: 180 minutes after the exercise training versus at rest.
|
Fluorometric determination of muscle glycogen levels
|
On each test-day: 180 minutes after the exercise training versus at rest.
|
|
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.
|
Change from rest to different time-points after exercise (0, 30, 60, 120 and 180 minutes after the exercise training).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate during the exercise training
Time Frame: Continuously during training on each test-day.
|
Heart rate during the exercise training.
|
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.
|
Capillary lactate concentration.
|
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.
|
Capillary glucose concentration.
|
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.
|
histamine concentration in blood samples.
|
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.
|
insulin concentration in blood samples.
|
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.
|
Phosphorylation status of proteins assessed by Western Blotting
|
On each test-day: at rest, 0 minutes and 180 minutes after the exercise training.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wim Derave, Professor, University Ghent
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)
August 16, 2021
Primary Completion (Actual)
December 6, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
October 15, 2021
First Submitted That Met QC Criteria
November 11, 2021
First Posted (Actual)
November 23, 2021
Study Record Updates
Last Update Posted (Actual)
April 12, 2024
Last Update Submitted That Met QC Criteria
April 11, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AET - BC-10237
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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