Postexercise HypotensionEarly Phase 1NCT05206227
Histamine as a Molecular Transducer of Adaptation to Exercise
A Early Phase 1 study testing Aerobic Exercise, alpha-FMH and Resistance and Aerobic Exercise in people with Postexercise Hypotension, run by University of Oregon at 1 site in United States.
Trial summary
This study is investigating the role of histamine in generating adaptation to exercise Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postexercise Hypotension
- What is being tested?
- Aerobic Exercise, alpha-FMH and Resistance and Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 31 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 -40
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postexercise Hypotension
- Being tested
- Aerobic Exercise, alpha-FMH, Resistance and Aerobic Exercise, Antihistamine
- Keywords
- Histamine, Mast cell, Exercise
- Medical subject headings
- Post-Exercise Hypotension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Subjects will complete a single bout of aerobic exercise.
alpha-FMHDrug
Also called Heating
Subjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna.
Resistance and Aerobic ExerciseBehavioural
Subjects will complete bouts of resistance and aerobic exercise.
AntihistamineDrug
Subjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Blood and skeletal muscle microdialysate collected during dynamic knee-extension exercise Receives: Behavioral: Aerobic Exercise |
| Heating | Experimental | Blood and skeletal muscle microdialysate collected during local and/or whole body heating Receives: Drug: alpha-FMH |
| Resistance and Aerobic Exercise | Experimental | Blood and urine collected during recovery from two modalities of exercise (This arm is now CLOSED) Receives: Behavioral: Resistance and Aerobic Exercise |
| Aerobic Exercise and Muscle Perfusion | Experimental | Muscle perfusion measured during aerobic exercise (This arm is now CLOSED) Receives: Behavioral: Aerobic Exercise; Drug: Antihistamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of mast cell degranulation
Beta-hexosaminidase release from mast cells in mast cell degranulation bioassay when exposed to intramuscular dialysate from exercising individuals
Measured: One hour
Histamine concentration
Histamine concentration in intramuscular dialysate
Measured: One hour
Histamine metabolites
Concentration of histamine metabolites in blood and urine
Measured: 24 hours
Muscle perfusion
Skeletal muscle tissue oxygen index
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start28 Jul 2021
- Primary completion31 Dec 2025
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postexercise HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John R Halliwill, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206227
- Sponsor's protocol ID
- Uoregon_STUDY0000001
- Other IDs
- STUDY00000718 (CLOSED), STUDY00000982 (CLOSED), STUDY00001088 (CLOSED)
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histamine as a Molecular Transducer of Adaptation to Exercise
- ClinicalTrials.gov ID
- NCT05206227
- Acronym / sponsor ID
- Uoregon_STUDY0000001
- Conditions
- Postexercise Hypotension
- Keywords
- Histamine, Mast cell, Exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseBlood and skeletal muscle microdialysate collected during dynamic knee-extension exercise |
| Heating | Experimental | Drug: alpha-FMHBlood and skeletal muscle microdialysate collected during local and/or whole body heating |
| Resistance and Aerobic Exercise | Experimental | Behavioral: Resistance and Aerobic ExerciseBlood and urine collected during recovery from two modalities of exercise (This arm is now CLOSED) |
| Aerobic Exercise and Muscle Perfusion | Experimental | Behavioral: Aerobic Exercise, Drug: AntihistamineMuscle perfusion measured during aerobic exercise (This arm is now CLOSED) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18 -40
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseSubjects will complete a single bout of aerobic exercise. | Behavioural | Aerobic Exercise, Aerobic Exercise and Muscle Perfusion |
| alpha-FMHAlso: HeatingSubjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna. | Drug | Heating |
| Resistance and Aerobic ExerciseSubjects will complete bouts of resistance and aerobic exercise. | Behavioural | Resistance and Aerobic Exercise |
| AntihistamineSubjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions. | Drug | Aerobic Exercise and Muscle Perfusion |
Primary outcome
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
Histamine concentration
Time frame: One hour
Histamine concentration in intramuscular dialysate
Histamine metabolites
Time frame: 24 hours
Concentration of histamine metabolites in blood and urine
Muscle perfusion
Time frame: One hour
Skeletal muscle tissue oxygen index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Halliwill, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aerobic Exercise, alpha-FMH and Resistance and Aerobic Exercise in people with Postexercise Hypotension, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of mast cell degranulation (time frame: One hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.