NCT04450134

Brief Summary

Exercise training is beneficial for both health and performance. Histamine has been shown to be involved in the acute exercise response. The current study addresses the role of histamine H1/H2 receptor signaling in the chronic training-induced adaptations. Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 2, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 9, 2020

Last Update Submit

June 5, 2024

Conditions

Exercise TrainingPhysical Activity

Keywords

ExercisePhysiology

Outcome Measures

Primary Outcomes (4)

  • Change in cardiorespiratory fitness

    Change in maximal oxygen uptake during incremental cycling test on cycle ergometer during the 6 week training period

    Before, after 3 weeks and after 6 weeks of exercise training

  • Change in peak aerobic power output

    Change in peak power output during incremental cycling test on cycle ergometer during the 6 week training period

    Before, after 3 weeks and after 6 weeks of exercise training

  • Change in whole-body insulin sensitivity

    Change from baseline in Matsuda index for whole-body insulin sensitivity derived from Oral Glucose Tolerance Test after the 6 week training period

    Before and after 6 weeks of exercise training

  • Change in microvascular function

    Change from baseline in microvascular function (Single Passive Leg Movement technique) after the 6 week training period

    Before and after 6 weeks of exercise training

Secondary Outcomes (17)

  • Change in skeletal muscle capillarization

    Before and after 6 weeks of exercise training

  • Change in skeletal muscle enzyme activity

    Before and after 6 weeks of exercise training

  • Change in skeletal muscle protein content

    Before and after 6 weeks of exercise training

  • Change in power output at Gas Exchange Threshold (GET)

    Before, after 3 weeks and after 6 weeks of exercise training

  • Change in power output at Respiratory Compensation Point (RCP)

    Before, after 3 weeks and after 6 weeks of exercise training

  • +12 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

6 weeks high-intensity interval training + placebo intake

Other: LactoseOther: High-intensity interval training (HIIT)

Blockade

EXPERIMENTAL

6 weeks high-intensity interval training + histamine H1/H2 receptor blockade

Drug: Fexofenadine HydrochlorideDrug: FamotidineOther: High-intensity interval training (HIIT)

Interventions

LactoseOTHER

Placebo: Lactose capsules

Placebo
Fexofenadine HydrochlorideDRUG

H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride

Blockade
FamotidineDRUG

H2 receptor antagonist: 40 mg Famotidine

Blockade
High-intensity interval training (HIIT)OTHER

6 weeks HIIT

BlockadePlacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary or low levels of physical activity
  • Caucasian

You may not qualify if:

  • Chronic diseases
  • Medication use
  • Smoking
  • Excessive alcohol consumption
  • Seasonal allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Movement and Sports Sciences, Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Interventions

LactosefexofenadineFamotidineHigh-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind for researchers and participants
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Placebo + exercise vs histamine blockade + exercise
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 29, 2020

Study Start

October 2, 2019

Primary Completion

December 18, 2019

Study Completion

April 14, 2021

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations

BE(1)