Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT05298202
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Influence of Capsaicin Gel During Exercise Within the Heat
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002211', 'term': 'Capsaicin'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dustin.slivka@umontana.edu', 'phone': '(406) 243-2389', 'title': 'Dustin Slivka', 'organization': 'University of Montana'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through three visits, maximum of 29 days', 'eventGroups': [{'id': 'EG000', 'title': 'Capsaicin Gel Application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat\n\nCapsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hypoallergenic Gel Application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat\n\nControl Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skin Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsaicin Gel Application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat\n\nCapsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}, {'id': 'OG001', 'title': 'Hypoallergenic Gel Application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat\n\nControl Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}], 'classes': [{'categories': [{'measurements': [{'value': '188.4', 'spread': '104.9', 'groupId': 'OG000'}, {'value': '139.2', 'spread': '56.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.284', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'difference between treatment and control', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'time x treatment ANOVA'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes into exercise bout', 'description': 'Laser Doppler measurement of skin blood flow on the forearm. This is measured in arbitrary units where higher values represent higher blood flow.', 'unitOfMeasure': 'arbitrary units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sweat Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsaicin Gel Application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat\n\nCapsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}, {'id': 'OG001', 'title': 'Hypoallergenic Gel Application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat\n\nControl Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}], 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '17.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.177', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Final 10 minutes of the exercise bout (minutes 20-30 of exercise)', 'description': 'Sodium concentrations in collected sweat', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sweat Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsaicin Gel Application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat\n\nCapsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}, {'id': 'OG001', 'title': 'Hypoallergenic Gel Application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat\n\nControl Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}], 'classes': [{'categories': [{'measurements': [{'value': '1.23', 'spread': '.37', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.122', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'pre-post 30 minute exercise bout', 'description': 'To calculate sweat rate the difference in Nude body weight from pre to post exercise was measured (assuming weight loss is equal to sweat loss)', 'unitOfMeasure': 'Liters per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Thermal Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsaicin Gel Application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat\n\nCapsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}, {'id': 'OG001', 'title': 'Hypoallergenic Gel Application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat\n\nControl Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '.4', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.038', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'time x treatment anova'}], 'paramType': 'MEAN', 'timeFrame': 'at 30 minutes of exercise', 'description': 'scale of thermal comfort developed by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). The ASHRAE is a 7-point scale to asses thermal sensation, which consists of seven verbal anchors: "cold (-3)", "cool (-2)", "slightly cool (-1)", "neutral (0)", "slightly warm (1)", "warm (2)", and "hot (3)". The score is reported as the value in "()"', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Average Skin Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsaicin Gel Application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat\n\nCapsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}, {'id': 'OG001', 'title': 'Hypoallergenic Gel Application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat\n\nControl Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}], 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '.5', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.976', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 30 minutes of the exercise bout', 'description': 'average measurements from chest, forearm, and calf thermistors', 'unitOfMeasure': 'degrees C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Core Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsaicin Gel Application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat\n\nCapsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}, {'id': 'OG001', 'title': 'Hypoallergenic Gel Application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat\n\nControl Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle\n\nExercise: treadmill walking 3.5 mph at 5% grade\n\nHot environment: 38°C, 60% relative humidity'}], 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '.6', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.747', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at 30 minutes of the exercise bout', 'description': 'measured with rectal thermistor', 'unitOfMeasure': 'degrees C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Capsaicin First (1 Day), Washout (7days) Then Hypoallergenic Gel (1 Day).', 'description': 'Capsaicin first, then hypoallergenic Gel.\n\nAll participants will receive both Capsaicin and Control hypoallergenic cream (cross-over design ,randomized order, 7 days washout between) applied to the skin prior to exercise in the heat.\n\nboth cremes were applied on the skin shoulder to wrist and mid-thigh to ankle.'}, {'id': 'FG001', 'title': 'Hypoallergenic Gel First (1 Day), Washout (7 Days), Then Capsaicin (1 Day)', 'description': 'hypoallergenic Gel first, then Capsaicin\n\nAll participants will receive both Capsaicin and Control hypoallergenic cream (cross-over design ,randomized order, 7 days washout between) applied to the skin prior to exercise in the heat.\n\nboth cremes were applied on the skin shoulder to wrist and mid-thigh to ankle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants will receive both Capsaicin and Control hypoallergenic cream (randomized order, 7 days washout between) applied to the skin prior to exercise in the heat'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '18.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '177.4', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'body fat', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent body fat', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-25', 'size': 126343, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-23T13:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each Subject acts as their own control in a repeated measures design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2022-03-17', 'resultsFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-13', 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Blood Flow', 'timeFrame': '30 minutes into exercise bout', 'description': 'Laser Doppler measurement of skin blood flow on the forearm. This is measured in arbitrary units where higher values represent higher blood flow.'}, {'measure': 'Sweat Composition', 'timeFrame': 'Final 10 minutes of the exercise bout (minutes 20-30 of exercise)', 'description': 'Sodium concentrations in collected sweat'}, {'measure': 'Sweat Rate', 'timeFrame': 'pre-post 30 minute exercise bout', 'description': 'To calculate sweat rate the difference in Nude body weight from pre to post exercise was measured (assuming weight loss is equal to sweat loss)'}, {'measure': 'Thermal Perception', 'timeFrame': 'at 30 minutes of exercise', 'description': 'scale of thermal comfort developed by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). The ASHRAE is a 7-point scale to asses thermal sensation, which consists of seven verbal anchors: "cold (-3)", "cool (-2)", "slightly cool (-1)", "neutral (0)", "slightly warm (1)", "warm (2)", and "hot (3)". The score is reported as the value in "()"'}, {'measure': 'Average Skin Temperature', 'timeFrame': 'at 30 minutes of the exercise bout', 'description': 'average measurements from chest, forearm, and calf thermistors'}, {'measure': 'Core Temperature', 'timeFrame': 'at 30 minutes of the exercise bout', 'description': 'measured with rectal thermistor'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heat exposure', 'exercise', 'capsaicin'], 'conditions': ['Acute Exercise', 'Heat Exposure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available capsaicin gel to the skin prior to moderate intensity walking under heated conditions. Experimental Visits will consist of 30 min of treadmill walking at a moderate pace (3.5 mph, 5% grade) under hot conditions (38°C, 60%RH) and will be randomized and counterbalanced for capsaicin gel or a hypoallergenic gel (control) application.\n\nGels will be applied to areas commonly exposed during outdoor activity in warm conditions (shoulder to wrist, mid thigh to ankle). Accordingly, participants will wear shorts and a tank top shirt during exercise. Core temperature, skin temperature, galvanic skin response, laser doppler blood flow, and heart rate will be continuously recorded throughout the exercise bout via an integrated analog to digital converter. Sweat will be collected during exercise using commercially available absorbent patches. Thermal sensation will be assessed throughout exercise via the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) thermal sensation likert scale (cold to hot).\n\nLastly, nude body weight will be recorded pre and post exercise for sweat rate determination. The capsaicin and control trials will be separated by a 7-14 day washout period', 'detailedDescription': '3 experimental visits to the laboratory will be conducted. All visits will take place at the University of Nebraska at Omaha, Exercise Physiology Laboratory. Visit 1 will consist of the physical activity readiness questionnaire (PARQ), adverse reaction to capsaicin, and body composition (hydrostatic weigh, bioelectrical impedance). Visits 2 and 3 will be separated by 7-14 days, randomized, and counterbalanced for experimental (capsaicin) and control (hypoallergenic cream) trials. Both the experimental and control visits will follow the same protocol.\n\nParticipants will arrive following an overnight fast state while also refraining from strenuous activity, alcohol consumption, tobacco use, and recreational drugs for the previous 24 hour period. During these visit researchers will apply capsaicin using a gloved hand from shoulder to wrist and mid thigh to ankle (areas outside of the clothing). A hypoallergenic cream will be applied during the control visit.\n\nExercise will consist of 30 min of moderate intensity treadmill walking (3.5 mph at 5% grade) within a heated temperature/humidity controlled chamber (38°C, 60% relative humidity). Participants will be weighed before, and after completion of the exercise calculate sweat rate. Prior to the exercise session, participants will sit for 5 min in an ambient room temperature environment as a baseline. During baseline and during the exercise core temperature, skin temperature, laser doppler blood flow, galvanic skin response, and heart rate will be collected continuously. Sweat patches will be adhered to the forehead during exercise at minute 10 for collection of sweat composition over the next 10-20 minutes. Thermal perception using the ASHRAE scale (cold to hot) will be assessed pre and during exercise.\n\nEXPERIMENTAL VISIT 1 Visit 1 will take approximately 1 hour. Participants will then complete the physical activity readiness questionnaire (PARQ) to be cleared for physical activity. Participants will have a small amount of the capsaicin cream applied to a small area of the forearm (\\~2 x 2 in) to test for any adverse reaction over a period of 15 minutes. Those without a reaction will have height, weight, and body fat composition measured. Height and weight will be measured using a medical scale and stadiometer, respectively. Body fat will be assessed with hydrostatic weighing using an electronic load cell based system (Exertech, Dresbach, MN) correcting for residual lung volume or via a bio-electrical impedance analyzer (InBodyUSA, Cerritos, CA).\n\nEXPERIMENTAL VISITS 2 AND 3 Visits 2 and 3 will take approximately 2 hours each. Upon arrival at the lab, a nude body weight will be collected with the subject in a private room. While still in the room, subjects will self-insert a rectal thermistor 12-15 cm beyond the anal sphincter and don a chest strap heart rate monitor. After dressing in their exercise clothing, subjects will exit the private room so that chest, forearm, and calf thermistors can be adhered to the skin with tape. Laser doppler flow (forearm and or/finger) will be adhered with tape and galvanic skin response (fingers) will be adhered using Velcro straps to the skin. Measuring instruments will be recorded using an integrated digital to analog converter (ADInstruments, Colorado Springs, CO).\n\nFollowing instrumentation, subjects will sit for 5 minutes as a baseline in a temperate environment. Immediately after, a researcher with gloved hands will topically apply capsaicin or the control hypoallergenic cream from the shoulder to wrist and mid-thigh to ankle. Subjects will then enter the heat chamber (38°C, 60% relative humidity) and immediately begin a 30-minute walk on a treadmill (3.5 mph, 5% grade). Subjects will be intermittently asked to hold their arm steady for laser doppler flow collection (10, 20, 30 minutes). Subjects will also briefly pause at minute 10 in order to adhere an absorbent patch to their forehead for sweat collection over the following 10-20 minutes. Thermal perception using the ASHRAE scale (cold to hot) will be assessed pre and during exercise. After 30 minutes of walking, subjects will exit the chamber for removal of all skin and finger sensors. Subjects will then re-enter the private room, remove their own rectal thermistor with gloved hands, and then a final nude body weight will be recorded after toweling off.\n\nThe rectal thermistor will measure core temperature. The heart rate monitor will measure the beats of the heart. Skin thermistors will measure the temperature of the skin surfaces. Laser doppler flow measure the relative units of blood flow velocity. Galvanic skin response measures skin conductivity changes as individuals begin to sweat. Sweat is collected for assessment of sweat composition. Thermal perception is assessed for individual perception surrounding the temperature of the ambient environment. Nude body weight is measured to calculate sweat rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19-45 years of age\n* cleared for physical activity via the 2022 physical activity readiness questionnaire (PARQ)\n* no self-reported adverse reactions to capsaicin\n\nExclusion Criteria:\n\n* outside 19-45 years of age\n* not cleared for physical activity via the 2022 physical activity readiness questionnaire (PARQ)\n* self-report or signs of sensitivity to capsaicin\n* pregnant\n* breast feeding'}, 'identificationModule': {'nctId': 'NCT05298202', 'briefTitle': 'The Influence of Capsaicin Gel During Exercise Within the Heat', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'The Influence of Topical Capsaicin on Thermoregulatory and Perceptual Outcomes During Exercise Within the Heat', 'orgStudyIdInfo': {'id': '0192-22-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capsaicin gel application', 'description': 'Capsaicin gel will be applied to the skin prior to exercise in the heat', 'interventionNames': ['Biological: Capsaicin', 'Other: Exercise', 'Other: Hot environment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hypoallergenic gel application', 'description': 'A hypoallergenic gel will be applied to the skin prior to exercise in the heat', 'interventionNames': ['Biological: Control Gel', 'Other: Exercise', 'Other: Hot environment']}], 'interventions': [{'name': 'Capsaicin', 'type': 'BIOLOGICAL', 'description': 'application of capsaicin gel from shoulder to wrist and mid thigh to ankle', 'armGroupLabels': ['Capsaicin gel application']}, {'name': 'Control Gel', 'type': 'BIOLOGICAL', 'description': 'application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle', 'armGroupLabels': ['Hypoallergenic gel application']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'treadmill walking 3.5 mph at 5% grade', 'armGroupLabels': ['Capsaicin gel application', 'Hypoallergenic gel application']}, {'name': 'Hot environment', 'type': 'OTHER', 'description': '38°C, 60% relative humidity', 'armGroupLabels': ['Capsaicin gel application', 'Hypoallergenic gel application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68182', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska at Omaha', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Dustin R Slivka, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}