Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05206227

Histamine as a Molecular Transducer of Adaptation to Exercise

This study is investigating the role of histamine in generating adaptation to exercise

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

About this study

Exercise promotes and maintains healthy cardiovascular, musculoskeletal, and metabolic function, but the signals and mechanisms which transduce these effects are poorly understood. Histamine plays a role in some of the positive benefits of exercise. The goal of this study is to determine the factors that regulate exercise's effects on endothelial and vascular function, with a focus on histamine released from mast cells in skeletal muscle. Participants will perform exercise or participate in interventions like heating that may replicate some of the effects of exercise. During most experiments, investigators will insert an intravenous catheter in an arm vein and microdialysis probes in the leg, collect dialysate from the microdialysis probe and blood from the vein, record noninvasive measures, and have the participants perform exercise or undergo heating.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 -40

Exclusion criteria

  • Systolic ≥ 120
  • Diastolic ≥ 80
  • Body mass index (BMI) ˃ 28 kg/m2
  • Prior diagnosis of cardiovascular disease, diabetes, autonomic disorders, or asthma
  • Smoking or nicotine use
  • Ongoing medical therapy (other than birth control)
  • Ongoing use of over-the-counter or prescription antihistamines
  • Allergies or hypersensitivities to drugs, local anesthetics, skin disinfectants, adhesives, or latex
  • Pregnant, breastfeeding subjects, or planning to become pregnant in the next 12 months
  • Mobility restrictions that interfere with physical activity
  • High physical activity based on International Physical Activity Questionaire (IPAQ1)
  • Non-English speaking

Treatment and study plan

Aerobic Exercise

Behavioral

Subjects will complete a single bout of aerobic exercise.

alpha-FMH

Drug

Subjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna.

Other names: Heating

Resistance and Aerobic Exercise

Behavioral

Subjects will complete bouts of resistance and aerobic exercise.

Antihistamine

Drug

Subjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions.

Primary outcomes

  1. Percentage of mast cell degranulation

    Time frame: One hour

    Beta-hexosaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals

  2. Histamine concentration

    Time frame: One hour

    Histamine concentration in intramuscular dialysate

  3. Histamine metabolites

    Time frame: 24 hours

    Concentration of histamine metabolites in blood and urine

  4. Muscle perfusion

    Time frame: One hour

    Skeletal muscle tissue oxygen index

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Jan 25, 2022
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.