NCT06152497

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2023Dec 2026

First Submitted

Initial submission to the registry

December 20, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

3.3 years

First QC Date

December 20, 2022

Last Update Submit

December 6, 2023

Conditions

Histamine

Outcome Measures

Primary Outcomes (5)

  • Muscle volume

    Change in muscle volume

    Before and after the 10 weeks of resistance training

  • Maximal dynamic strength of leg press, bench press, bicep curl and leg curl

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

    Before and after the 10 weeks of resistance training

  • Muscle fiber hypertrophy in muscle biopsies

    Change in muscle fiber hypertrophy in muscle biopsies

    Before and after the 10 weeks of resistance training

  • Matsuda index, to estimate whole body glucose metabolism, will be calculated using an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood will be measured before and after drinking 75g glucose)

    Change in Matsuda index, to estimate whole body glucose metabolism, will be calculated using an oral glucose tolerance test (OGTT: concentration of glucose and insulin in the blood will be measured before and after drinking 75g glucose)

    Before and after the 10 weeks of resistance training

  • 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)

    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)

    Before and after the 10 weeks of resistance training

Secondary Outcomes (2)

  • Blood pressure (systolic and diastolic)

    Before and after the 10 weeks of resistance training

  • Resting heart rate

    Before and after the 10 weeks of resistance training

Study Arms (2)

1: Placebo

PLACEBO COMPARATOR

Lactose

Drug: PlaceboBehavioral: Resistance training

H1 blockade: Telfast (180mg Fexofenadine)

EXPERIMENTAL

H1: Telfast (180mg Fexofenadine)

Drug: H1 blockade: Telfast: 180mg FexofenadineBehavioral: Resistance training

Interventions

PlaceboDRUG

Oral placebo

1: Placebo
H1 blockade: Telfast: 180mg FexofenadineDRUG

H1 blockade: oral blockade with 180mg Fexofenadine

H1 blockade: Telfast (180mg Fexofenadine)
Resistance trainingBEHAVIORAL

Resistance training: lower body exercise

1: PlaceboH1 blockade: Telfast (180mg Fexofenadine)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • years
  • Not to medium physically active

You may not qualify if:

  • Smoking
  • Chronic disease
  • High blood pressure
  • Supplement or medication intake
  • Seasonal allergies
  • Vegetarian / vegan
  • Resistance trained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of movement and sports sciences, Ghent University, Belgium

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

fexofenadineResistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wim Derave, Professor

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wim Derave, Professor

CONTACT

92646326wim.derave@ugent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2022

First Posted

November 30, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

BE(1)