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Histamine as a Molecular Transducer of Adaptation to Exercise

Histamine as a Molecular Transducer of Adaptation to Exercise

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05206227
Enrollment
80
Registered
2022-01-25
Start date
2021-07-28
Completion date
2027-03-31
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postexercise Hypotension

Keywords

Histamine, Mast cell, Exercise

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALAerobic Exercise

Subjects will complete a single bout of aerobic exercise.

DRUGalpha-FMH

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

Subjects will complete bouts of resistance and aerobic exercise.

DRUGAntihistamine

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

Sponsors

University of Oregon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

This is a series of Basic Experimental Studies with Humans (BESH, as defined by PA-20-184). Subjects are enrolled (non-randomized) in different arms of the overall study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of mast cell degranulationOne hourBeta-hexosaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals
Histamine concentrationOne hourHistamine concentration in intramuscular dialysate
Histamine metabolites24 hoursConcentration of histamine metabolites in blood and urine
Muscle perfusionOne hourSkeletal muscle tissue oxygen index

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJohn R Halliwill, PhD

University of Oregon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026