Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-29 @ 12:05 PM
Study NCT ID:
NCT03958734
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2019-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting triglycerides', 'timeFrame': 'Baseline', 'description': 'Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.'}, {'measure': 'Post HFM Triglycerides', 'timeFrame': '4 hours', 'description': 'Ester derived from glycerol and three fatty acids, representative of the main constituent of body fat in humans.'}, {'measure': 'Fasting total cholesterol', 'timeFrame': 'Baseline', 'description': 'Type of lipid that is required for cell structure, but can contribute to increased risk of heart disease if high due to development of fatty deposits on vascular wall.'}, {'measure': 'Post HFM total cholesterol', 'timeFrame': '4 hours', 'description': 'Type of lipid that is required for cell structure, but can contribute to increased risk of heart disease if high due to development of fatty deposits on vascular wall.'}, {'measure': 'Fasting LDL', 'timeFrame': 'Baseline', 'description': 'Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.'}, {'measure': 'Post HFM LDL', 'timeFrame': '4 hours', 'description': 'Low density lipoprotein that transports fat molecules in the body. Associated with high levels of cholesterol.'}, {'measure': 'Fasting HDL', 'timeFrame': 'Baseline', 'description': 'High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.'}, {'measure': 'Post HFM HDL', 'timeFrame': '4 hours', 'description': 'High density lipoprotein that transports fat molecules in the body. Associated with carrying cholesterol to the liver for degradation.'}, {'measure': 'Fasting non-HDL', 'timeFrame': 'Baseline', 'description': 'Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.'}, {'measure': 'Post HFM non-HDL', 'timeFrame': '4 hours', 'description': 'Total cholesterol minus HDL, often associated with a better assessment of risk for heart disease.'}, {'measure': 'Fasting LDL/HDL ratio', 'timeFrame': 'Baseline', 'description': 'Assessment of risk for heart disease.'}, {'measure': 'Post HFM LDL/HDL ratio', 'timeFrame': '4 hours', 'description': 'Assessment of risk for heart disease.'}, {'measure': 'Fasting anti-inflammatory surface receptor expression', 'timeFrame': 'Baseline', 'description': 'CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.'}, {'measure': 'Post HFM anti-inflammatory surface receptor expression', 'timeFrame': '4 hours', 'description': 'CD14, CD206 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.'}, {'measure': 'Fasting pro-inflammatory surface receptor expression', 'timeFrame': 'Baseline', 'description': 'CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.'}, {'measure': 'Post HFM pro-inflammatory surface receptor expression', 'timeFrame': '4 hours', 'description': 'CD16, CD86 - monocyte receptors associated with defining subsets and inflammatory differentiation of macrophages.'}, {'measure': 'Fasting brachial artery flow-mediated dilation', 'timeFrame': 'Baseline', 'description': 'Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.'}, {'measure': 'Post HFM brachial artery flow-mediated dilation', 'timeFrame': '5.5 hours', 'description': 'Dilation of brachial artery when blood flow increases in artery. Measured by non-invasive ultrasound.'}, {'measure': 'Fasting superficial artery flow-mediated dilation', 'timeFrame': 'Baseline', 'description': 'Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.'}, {'measure': 'Post HFM superficial artery flow-mediated dilation', 'timeFrame': '5.5 hours', 'description': 'Dilation of superficial artery when blood flow increases in artery. Measured by non-invasive ultrasound.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Dysfunction'], 'conditions': ['Cardiovascular Risk Factor', 'Lipemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to examine the effect of high-fat meals on the health of blood vessels. In addition, the study will examine how exercise/fitness/physical activity impacts blood vessels after consumption of a high-fat meal.', 'detailedDescription': "This is the first in a series of studies examining the impact of high-fat meals on blood vessels. During the preliminary visit of this study, eligible participants' resting metabolic rate, arm flow mediated dilation, and leg flow mediate dilation will be measured. They will complete handgrip and plantar flexion exercise tasks. Finally, they will be given a physical activity monitor to wear for 7 days. At their first visit, participants will eat a high-fat meal and blood will be drawn to measure blood vessel health. They will also repeat the arm flow mediated dilation, leg flow mediate dilation, handgrip, and plantar flexion exercise tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. college-age: 18-30 years old\n2. normal fasting triglyceride (\\<150 mg/dL) (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition).\n3. normal body composition: % body fat, males \\<25%, females \\<32% (American College of Sports Medicine Guidelines for Exercise Testing and Prescription, 10th Edition)\n4. self-reported engagement in moderate-vigorous intensity physical activity and/or an exercise training regimen OR self-reported low physical activity and no engagement in an exercise training regimen (International Physical Activity Questionnaire)\n5. low cardiorespiratory fitness (VO2peak; male: =\\<45 mL/kg/min; female: =\\<35 mL/kg/min; categorized as =40th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47) OR high cardiorespiratory fitness (VO2peak; male: =55 mL/kg/min; female: 45 mL/kg/min; categorized as =70th percentile by ACSM Guidelines for Exercise Testing and Prescription, 10th Edition; 44, 45, 46, 47)\n\nf.) for female participants, presence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods.\n\n.\n\nExclusion Criteria:\n\n1. presence of diagnosed cardiovascular, metabolic, or renal disease or dysfunction\n2. presence of signs and symptoms suggestive of cardiovascular, metabolic, or renal disease\n3. presence of musculoskeletal injury\n4. pregnancy\n5. history of smoking\n6. engagement in an abnormal eating behavior\n7. unable to communicate effectively in English\n8. moderate cardiorespiratory fitness (VO2peak; male: 46-54 mL/kg/min; female: 36-44 mL/kg/min)\n9. elevated or high fasting triglycerides (\\>150 mg/dL)\n10. absence of a normal, monthly menstrual cycle with or without prescribed contraceptive methods'}, 'identificationModule': {'nctId': 'NCT03958734', 'briefTitle': 'Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals - Study 1', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Postprandial Monocyte Maturation and Vascular Dysfunction Following High-Fat Meals: The Impact of Cardiovascular Fitness and Acute Aerobic Exercise - Study 1', 'orgStudyIdInfo': {'id': 'HM20015510-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low physical activity/fitness', 'description': 'Participants will be classified as into low-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.', 'interventionNames': ['Other: High-fat meal']}, {'type': 'OTHER', 'label': 'High physical activity/fitness', 'description': 'Participants will be classified as into high-physical fitness based on self-reported physical activity and cardiorespiratory fitness testing.', 'interventionNames': ['Other: High-fat meal']}], 'interventions': [{'name': 'High-fat meal', 'type': 'OTHER', 'description': "Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes", 'armGroupLabels': ['High physical activity/fitness', 'Low physical activity/fitness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Robert L Franco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sigma Xi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}