Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT05816551
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2023-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Aging and Gastrointestinal Barrier Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'craigcrandall@texashealth.org', 'phone': '214-345-4623', 'title': 'Craig Crandall, PhD, Primary Investigator', 'organization': 'Institute for Exercise and Environmental Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the two trials of the experiment or approximately 2 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Younger Participants Hyperthermia Trial', 'description': 'Individuals aged 18-39 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Older Participants Hyperthermia Trial', 'description': 'Individuals aged over 65 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Younger Participants Control Trial', 'description': 'Individuals aged 18-39 years\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Older Participants Control Trial', 'description': 'Individuals aged over 65 years\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Log Lactulose/Rhamnose Following Control Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Younger Participants', 'description': 'Individuals aged 18-39 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}, {'id': 'OG001', 'title': 'Older Participants', 'description': 'Individuals aged over 65 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.97', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '"Visit 1": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Log Lactulose/Rhamnose Following Hyperthermia Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Younger Participants', 'description': 'Individuals aged 18-39 years.\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.'}, {'id': 'OG001', 'title': 'Older Participants', 'description': 'Individuals aged over 65 years.\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '"Visit 2": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Log Sucrose Following Control Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Younger Participants', 'description': 'Individuals aged 18-39 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}, {'id': 'OG001', 'title': 'Older Participants', 'description': 'Individuals aged over 65 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.68', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '1.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '"Visit 1": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.', 'unitOfMeasure': 'log(ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Log Sucrose Following Hyperthermia Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Younger Participants', 'description': 'Individuals aged 18-39 years.\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.'}, {'id': 'OG001', 'title': 'Older Participants', 'description': 'Individuals aged over 65 years.\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '3.44', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '"Visit 2": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.', 'unitOfMeasure': 'log(ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Core Temperature During Hyperthermia Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Younger Participants', 'description': 'Individuals aged 18-39 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}, {'id': 'OG001', 'title': 'Older Participants', 'description': 'Individuals aged over 65 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.01', 'spread': '.14', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '"Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial.', 'description': 'Core temperature was measured using an orally ingestible telemetric pill that was taken no less than 1 hour before the baseline period.', 'unitOfMeasure': '°C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Younger Participants', 'description': 'Individuals aged 18-39 years\n\nHyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.\n\nControl Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.'}, {'id': 'FG001', 'title': 'Older Participants', 'description': 'Individuals aged over 65 years\n\nHyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.\n\nControl Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Control Trial', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Hyperthermia Trial', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'comment': '3 participants were withdrawn from the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'comment': '1 participant withdrew from the study.', 'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn by Primary Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Younger Participants', 'description': 'Individuals aged 18-39 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}, {'id': 'BG001', 'title': 'Older Participants', 'description': 'Individuals aged over 65 years\n\nHyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.\n\nControl Trial: Individuals will be exposed to a control trial (no hyperthermia).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '3', 'groupId': 'BG000'}, {'value': '72', 'spread': '3', 'groupId': 'BG001'}, {'value': '52', 'spread': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-07', 'size': 193318, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-07T15:32', 'hasProtocol': True}, {'date': '2024-10-07', 'size': 89081, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-07T15:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2023-03-15', 'resultsFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-21', 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Log Lactulose/Rhamnose Following Control Trial', 'timeFrame': '"Visit 1": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.'}, {'measure': 'Log Lactulose/Rhamnose Following Hyperthermia Trial', 'timeFrame': '"Visit 2": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.'}, {'measure': 'Log Sucrose Following Control Trial', 'timeFrame': '"Visit 1": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.'}, {'measure': 'Log Sucrose Following Hyperthermia Trial', 'timeFrame': '"Visit 2": 3-5 hours after ingestion of multiple sugar drink.', 'description': 'The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.'}], 'secondaryOutcomes': [{'measure': 'Change in Core Temperature During Hyperthermia Trial', 'timeFrame': '"Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial.', 'description': 'Core temperature was measured using an orally ingestible telemetric pill that was taken no less than 1 hour before the baseline period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging', 'Hyperthermia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.', 'detailedDescription': 'Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. Although gastrointestinal barrier dysfunction is a primary cause of heat related illness, little is known about the effects of aging on gastrointestinal barrier function during hyperthermia. The central hypothesis of this work is that the elderly exhibit greater gastrointestinal barrier dysfunction during hyperthermia. Participants will complete a control trial where gastrointestinal permeability (without heating) will be assessed in young and older adults. In the experimental trial, controlled hyperthermia will be achieved using a water perfused, tube lined suit. Core body temperature will be raised to a maximum of 2 degrees Celsius above the baseline value, or an absolute temperature of 39.5 degrees Celsius. Core temperature will not be collected during the control trial. Comprehensive assessments of gastrointestinal barrier function and systemic inflammation will be assessed in young and older adults. The expected outcome of this work will re-shape our understanding of the consequences of aging on gastrointestinal barrier function during heat waves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female individuals\n* 18-35 years or 65+ years of age\n* Free of any underlying moderate to serious medical conditions\n\nExclusion Criteria:\n\n* Known heart disease\n* Any chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, inflammatory bowel disease, and uncontrolled hypercholestrolmia etc;\n* Abnormality detected on routine screening suggestive of provocable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.\n* Current smokers, as well as individuals who regularly smoked within the past 3 years\n* Subject with a body mass index ≥35 kg/m2\n* Pregnant\n* Use of immunosuppressant drugs within last 4 weeks prior to screening\n* Use of antibiotics or antimicrobial medication in last month\n* Any previous abdominal surgery\n* Use of steroids in last 6 weeks\n* Regular use of probiotics in last month\n* Use of laxatives or anti-diarrhetic in last month'}, 'identificationModule': {'nctId': 'NCT05816551', 'briefTitle': 'Aging and Gastrointestinal Barrier Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Impact of Aging on Gastrointestinal Barrier Function During Hyperthermia', 'orgStudyIdInfo': {'id': 'STU-2023-0171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Younger participants', 'description': 'Individuals aged 18-39 years.', 'interventionNames': ['Other: Hyperthermia Trial', 'Other: Control Trial']}, {'type': 'EXPERIMENTAL', 'label': 'Older participants', 'description': 'Individuals aged over 65 years.', 'interventionNames': ['Other: Hyperthermia Trial', 'Other: Control Trial']}], 'interventions': [{'name': 'Hyperthermia Trial', 'type': 'OTHER', 'description': 'Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.', 'armGroupLabels': ['Older participants', 'Younger participants']}, {'name': 'Control Trial', 'type': 'OTHER', 'description': 'Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.', 'armGroupLabels': ['Older participants', 'Younger participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Presbyterian Hospital Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Craig G Crandall, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Craig Crandall', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}