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Clinical trial

Histamine as a Molecular Transducer of Adaptation to Exercise

ID
Name
Uoregon_STUDY0000001
Description
This study is investigating the role of histamine in generating adaptation to exercise
Trial arms
Trial start
2021-07-28
Estimated PCD
2025-12-31
Trial end
2026-03-31
Status
Recruiting
Phase
Early phase I
Treatment
Aerobic Exercise
Subjects will complete a single bout of aerobic exercise.
Arms:
Aerobic Exercise, Aerobic Exercise and Muscle Perfusion
alpha-FMH
Subjects will undergo either local heating with diathermy or whole body heating with far-infrared sauna.
Arms:
Heating
Other names:
Heating
Resistance and Aerobic Exercise
Subjects will complete bouts of resistance and aerobic exercise.
Arms:
Resistance and Aerobic Exercise
Antihistamine
Subjects will complete a single bout of aerobic exercise under placebo vs antihistamine conditions.
Arms:
Aerobic Exercise and Muscle Perfusion
Size
80
Primary endpoint
Percentage of mast cell degranulation
One hour
Histamine concentration
One hour
Histamine metabolites
24 hours
Muscle perfusion
One hour
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-10-10

1 organization

2 products

1 indication

Organization
University of Oregon
Product
alpha-FMH
Indication
Postexercise Hypotension
Product
Antihistamine