NCT05206227

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
11mo left

Started Jul 2021

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not 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 Progress84%
Jul 2021Mar 2027

Study Start

First participant enrolled

July 28, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

January 11, 2022

Last Update Submit

January 21, 2026

Conditions

Postexercise Hypotension

Keywords

HistamineMast cellExercise

Outcome Measures

Primary Outcomes (4)

  • Percentage of mast cell degranulation

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

    One hour

  • Histamine concentration

    Histamine concentration in intramuscular dialysate

    One hour

  • Histamine metabolites

    Concentration of histamine metabolites in blood and urine

    24 hours

  • Muscle perfusion

    Skeletal muscle tissue oxygen index

    One hour

Study Arms (4)

Aerobic Exercise

EXPERIMENTAL

Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise

Behavioral: Aerobic Exercise

Heating

EXPERIMENTAL

Blood and skeletal muscle microdialysate collected during local and/or whole body heating

Drug: alpha-FMH

Resistance and Aerobic Exercise

EXPERIMENTAL

Blood and urine collected during recovery from two modalities of exercise (This arm is now CLOSED)

Behavioral: Resistance and Aerobic Exercise

Aerobic Exercise and Muscle Perfusion

EXPERIMENTAL

Muscle perfusion measured during aerobic exercise (This arm is now CLOSED)

Behavioral: Aerobic ExerciseDrug: Antihistamine

Interventions

Aerobic ExerciseBEHAVIORAL

Subjects will complete a single bout of aerobic exercise.

Aerobic ExerciseAerobic Exercise and Muscle Perfusion
alpha-FMHDRUG

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

Also known as: Heating
Heating
Resistance and Aerobic ExerciseBEHAVIORAL

Subjects will complete bouts of resistance and aerobic exercise.

Resistance and Aerobic Exercise
AntihistamineDRUG

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

Aerobic Exercise and Muscle Perfusion

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 -40

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Post-Exercise HypotensionMotor Activity

Interventions

ExerciseHeatingHistamine Antagonists

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEnvironment, ControlledEnvironmentEnvironment and Public HealthHistamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • John R Halliwill, PhD

    University of Oregon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

July 28, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

March 31, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)