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

NCT05131555 | Completed

• 1 other identifier: AET - BC-10237
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Histamine

Outcome Measures

Primary Outcomes (5)

• Change in muscle transcriptome (direct response)

  RNA-sequencing

  On each test-day: 0 minutes after the exercise training versus at rest.

• Change in muscle transcriptome (delayed response)

  RNA-sequencing

  On each test-day: 180 minutes after the exercise training versus at rest.

• Muscle glycogen depletion

  Fluorometric determination of muscle glycogen levels

  On each test-day: 0 minutes after the exercise training versus at rest.

• Muscle glycogen resynthesis

  Fluorometric determination of muscle glycogen levels

  On each test-day: 180 minutes after the exercise training versus at rest.

• 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 Outcomes (6)

• Heart rate during the exercise training

  Continuously during training on each test-day.

• 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.

• 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.

• Blood histamine

  On each test-day at 6 time-points: at rest and 0, 30, 60, 120 and 180 minutes after the exercise training.

• Blood insulin

  On each test-day at 6 time-points: at rest and 0, 30, 60, 120 and 180 minutes after the exercise training.

Study Arms (3)

1: Placebo

PLACEBO COMPARATOR

lactose

Drug: Placebo: Placebo + exercise training.

H1 blockade

EXPERIMENTAL

540 mg Fexofenadine

Drug: H1 blockade: H1 receptor antagonist + exercise training

H2 blockade

EXPERIMENTAL

40 mg Famotidine

Drug: H2 Blockade: H2 receptor antagonist + exercise training

Interventions

Placebo: Placebo + exercise training. DRUG

Oral placebo Exercise training: Interval-based cycling exercise

1: Placebo

H1 blockade: H1 receptor antagonist + exercise training DRUG

H1 blockade: oral blockade Exercise training: Interval-based cycling exercise

H1 blockade

H2 Blockade: H2 receptor antagonist + exercise training DRUG

H2 blockade: oral blockade Exercise training: Interval-based cycling exercise

H2 blockade

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female
• years
• not to medium physically active

You may not qualify if:

• Smoking
• Chronic disease
• Supplement or medication intake
• Seasonal allergies

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Department of movement and sports sciences, Ghent University, Belgium

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wim Derave, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized double-blinded placebo-controlled cross-over interventional study

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 23, 2021
• Study Start: August 16, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 31, 2021
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

BE (1)