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Active, not recruitingNCT05206227Updated Jan 23, 2026

Histamine as a Molecular Transducer of Adaptation to Exercise

An Early Phase 1 interventional study of Aerobic Exercise and alpha-FMH in Postexercise Hypotension, sponsored by University of Oregon. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by University of Oregon · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2021, registered Jan 2022).
Phase
Early Phase 1
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Postexercise Hypotension

Keywords

  • Histamine
  • Mast cell
  • Exercise
03

In context

Post-Exercise Hypotension

22 studies on the registry are indexed under Post-Exercise Hypotension; 2 are open to participants now.

This study's planned enrollment of 80 is above the median of 21 across 22 interventional studies indexed under Post-Exercise Hypotension.

Browse Post-Exercise Hypotension studies →

Lead sponsor

University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 -40

Exclusion criteria

Exclusion Criteria:

  • Systolic ≥ 120
  • Diastolic ≥ 80
  • (BMI) ˃ 28 kg/m2
  • Prior diagnosis of cardiovascular disease, diabetes, autonomic disorders, or asthma
  • Smoking or nicotine use
  • Ongoing medical therapy (other than )
  • Ongoing use of over-the-counter or prescription antihistamines
  • Allergies or 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Aerobic Exercise

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

    Behavioral: Aerobic Exercise

  • Experimental
    Heating

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

    Drug: alpha-FMH

  • Experimental
    Resistance and Aerobic Exercise

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

    Behavioral: Resistance and Aerobic Exercise

  • Experimental
    Aerobic Exercise and Muscle Perfusion

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

    Behavioral: Aerobic Exercise · Drug: Antihistamine

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.

    Also known as: Heating

  • BehavioralResistance and Aerobic Exercise

    Subjects will complete bouts of resistance and aerobic exercise.

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

06

What researchers measure

Primary outcomes

  1. Percentage of mast cell degranulation

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

    Time frame: One hour

  2. Histamine concentration

    Histamine concentration in intramuscular dialysate

    Time frame: One hour

  3. Histamine metabolites

    Concentration of histamine metabolites in blood and urine

    Time frame: 24 hours

  4. Muscle perfusion

    Skeletal muscle tissue oxygen index

    Time frame: One hour

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2021 to primary completion in Dec 2025, 53 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2022
First posted
Jan 25, 2022
StartActual
Jul 28, 2021
Primary completionActual
Dec 31, 2025
CompletionEst.
Mar 31, 2027
Last update
Jan 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05206227
Lead sponsor
University of Oregon
Responsible party
Sponsor
First posted
Jan 25, 2022
Start date
Jul 28, 2021
Primary completion
Dec 31, 2025
Completion
Mar 31, 2027 (estimated)
Last update
Jan 23, 2026

Study contacts

John R Halliwill, PhD
principal investigator · University of Oregon

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Antihistamines

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