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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05131555
Other study ID # AET - BC-10237
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2021
Est. completion date December 31, 2021

Study information

Verified date April 2024
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 insights into the molecular mechanisms of adaptations to exercise training.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 31, 2021
Est. primary completion date December 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo: Placebo + exercise training.
Oral placebo Exercise training: Interval-based cycling exercise
H1 blockade: H1 receptor antagonist + exercise training
H1 blockade: oral blockade Exercise training: Interval-based cycling exercise
H2 Blockade: H2 receptor antagonist + exercise training
H2 blockade: oral blockade Exercise training: Interval-based cycling exercise

Locations

Country Name City State
Belgium Department of movement and sports sciences, Ghent University, Belgium Ghent Oost-Vlaanderen

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in muscle transcriptome (direct response) RNA-sequencing On each test-day: 0 minutes after the exercise training versus at rest.
Primary Change in muscle transcriptome (delayed response) RNA-sequencing On each test-day: 180 minutes after the exercise training versus at rest.
Primary Muscle glycogen depletion Fluorometric determination of muscle glycogen levels On each test-day: 0 minutes after the exercise training versus at rest.
Primary Muscle glycogen resynthesis Fluorometric determination of muscle glycogen levels On each test-day: 180 minutes after the exercise training versus at rest.
Primary Plasma volume change 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 Heart rate during the exercise training Heart rate during the exercise training. Continuously during training on each test-day.
Secondary Blood lactate 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.
Secondary Blood glucose 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.
Secondary Blood histamine 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.
Secondary Blood insulin 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.
Secondary Muscle signaling pathways relevant for glucose metabolism and cardiovascular health Phosphorylation status of proteins assessed by Western Blotting On each test-day: at rest, 0 minutes and 180 minutes after the exercise training.
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