The Role of Histamine in Muscle Protein Synthesis Following Resistance Training

• Sponsor: University Ghent (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06152497
• Collaborator: Research Foundation Flanders (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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 yield more insights into the molecular mechanisms of adaptations to exercise training.

Condition or Disease	Intervention/Treatment	Phase
Histamine	Drug: Placebo; Drug: H1 blockade: Telfast: 180mg Fexofenadine; Behavioral: Resistance training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel groupsParallel groups
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Role of Histamine in Muscle Protein Synthesis Following Chronic Resistance Training
• Actual Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1: Placebo Lactose	Drug: Placebo; Oral placebo; Behavioral: Resistance training; Resistance training: lower body exercise
Experimental: H1 blockade: Telfast (180mg Fexofenadine) H1: Telfast (180mg Fexofenadine)	Drug: H1 blockade: Telfast: 180mg Fexofenadine; H1 blockade: oral blockade with 180mg Fexofenadine; Behavioral: Resistance training; Resistance training: lower body exercise

Outcome Measures

Primary Outcome Measures

1. Muscle volume [Before and after the 10 weeks of resistance training]

   Change in muscle volume

2. Maximal dynamic strength of leg press, bench press, bicep curl and leg curl [Before and after the 10 weeks of resistance training]

   Change in maximal dynamic strength of leg press, bench press, bicep curl and leg curl

3. Muscle fiber hypertrophy in muscle biopsies [Before and after the 10 weeks of resistance training]

   Change in muscle fiber hypertrophy in muscle biopsies

4. Whole body glucose metabolism measured with an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood before and after drinking 75g glucose) [Before and after the 10 weeks of resistance training]

   Change in whole body glucose metabolism measured with an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood before and after drinking 75g glucose)

5. 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) [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)

Secondary Outcome Measures

1. Blood pressure (systolic and diastolic) [Before and after the 10 weeks of resistance training]

   Chance in Blood pressure (systolic and diastolic)

2. Resting heart rate [Before and after the 10 weeks of resistance training]

   Chance in Resting heart rate

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male

• 18-45 years

• Not to medium physically active

Exclusion Criteria:

• Smoking

• Chronic disease

• High blood pressure

• Supplement or medication intake

• Seasonal allergies

• Vegetarian / vegan

• Resistance trained

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: University Ghent
• ClinicalTrials.gov Identifier: NCT06152497
• Other Study ID Numbers: MPSH - ONZ-2023-0027
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fexofenadine

Study Results

No Results Posted as of Nov 30, 2023