Influence of Endurance Exercise and Histamine Receptors on the Gene Expression in Skeletal Muscle

• Sponsor: University Ghent (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05131555
• Collaborator: Research Foundation Flanders (Other)
• Enrollment: 14
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Exercise; Histamine	Drug: Placebo: Placebo + exercise training.; Drug: H1 blockade: H1 receptor antagonist + exercise training; Drug: H2 Blockade: H2 receptor antagonist + exercise training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized double-blinded placebo-controlled cross-over interventional studyRandomized double-blinded placebo-controlled cross-over interventional study
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Influence of Endurance Training and Histamine Receptor Antagonists on the Transcriptome Response in Human Muscle
• Actual Study Start Date: Aug 16, 2021
• Anticipated Primary Completion Date: Dec 15, 2021
• Anticipated Study Completion Date: Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1: Placebo lactose	Drug: Placebo: Placebo + exercise training.; Oral placebo Exercise training: Interval-based cycling exercise
Experimental: H1 blockade 540 mg Fexofenadine	Drug: H1 blockade: H1 receptor antagonist + exercise training; H1 blockade: oral blockade Exercise training: Interval-based cycling exercise
Experimental: H2 blockade 40 mg Famotidine	Drug: H2 Blockade: H2 receptor antagonist + exercise training; H2 blockade: oral blockade Exercise training: Interval-based cycling exercise

Outcome Measures

Primary Outcome Measures

1. Change in muscle transcriptome (direct response) [On each test-day: 0 minutes after the exercise training versus at rest.]

   RNA-sequencing

2. Change in muscle transcriptome (delayed response) [On each test-day: 180 minutes after the exercise training versus at rest.]

   RNA-sequencing

3. Muscle glycogen depletion [On each test-day: 0 minutes after the exercise training versus at rest.]

   Fluorometric determination of muscle glycogen levels

4. Muscle glycogen resynthesis [On each test-day: 180 minutes after the exercise training versus at rest.]

   Fluorometric determination of muscle glycogen levels

5. Plasma volume change [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.

Secondary Outcome Measures

1. Heart rate during the exercise training [Continuously during training on each test-day.]

   Heart rate during the exercise training.

2. Blood lactate [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.

3. Blood glucose [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.

4. Blood histamine [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.

5. Blood insulin [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.

6. Muscle signaling pathways relevant for glucose metabolism and cardiovascular health [On each test-day: at rest, 0 minutes and 180 minutes after the exercise training.]

   Phosphorylation status of proteins assessed by Western Blotting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male and female

• 18-45 years

• not to medium physically active

Exclusion Criteria:

• Smoking

• Chronic disease

• Supplement or medication intake

• Seasonal allergies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of movement and sports sciences, Ghent University, Belgium	Ghent	Oost-Vlaanderen	Belgium	9000

Sponsors and Collaborators

• University Ghent
• Research Foundation Flanders

Investigators

• Principal Investigator: Wim Derave, Professor, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wim Derave, Full Professor, University Ghent
• ClinicalTrials.gov Identifier: NCT05131555
• Other Study ID Numbers: AET
• First Posted: Nov 23, 2021
• Last Update Posted: Nov 23, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Histamine H2 Antagonists; Histamine H1 Antagonists

Study Results

No Results Posted as of Nov 23, 2021