Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-04-24 @ 6:27 PM
Study NCT ID:
NCT03063320
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Spice Consumption on Postprandial Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Person assessing the outcome measures will be blinded to participant allocation'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '3 period randomized cross over'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in flow mediated dilation', 'timeFrame': 'Change from baseline at 2 hours and 4 hours after meal consumption', 'description': 'Endothelial function measured by FMD'}], 'secondaryOutcomes': [{'measure': 'Lipid and lipoproteins', 'timeFrame': 'Change from baseline during the 4 hours after meal consumption', 'description': 'Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides'}, {'measure': 'Plasma Inflammatory cytokines', 'timeFrame': 'Change from baseline during the 4 hours after meal consumption', 'description': 'Serum: IL-1β, IL-6, IL-10, IL-12p70, interferon-gamma, monocyte chemoattractant protein-1, macrophage inflammatory protein-1alpha, TNF-alpha, vascular endothelial growth factor'}, {'measure': 'Inflammatory cytokines in isolated peripheral blood mononuclear cells', 'timeFrame': 'Change from baseline during the 4 hours after meal consumption', 'description': 'TNF-alpha, IL-6,NF-κB, I-κB, MAP kinase, COX-2, iNOS from stimulated and unstimulated lipopolysaccharides in peripheral blood mononuclear cells. Activation status of macrophages.'}, {'measure': 'Glucose', 'timeFrame': 'Change from baseline during the 4 hours after meal consumption', 'description': 'Plasma glucose'}, {'measure': 'Insulin', 'timeFrame': 'Change from baseline during the 4 hours after meal consumption', 'description': 'Plasma insulin'}, {'measure': 'Plasma antioxidants', 'timeFrame': 'Change from baseline during the 4 hours after meal consumption', 'description': 'hydrophilic ORAC, lipophilic ORAC, total ORAC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': 'A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.', 'detailedDescription': 'A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking Waist circumference \\>= 94cm for men and \\>=80cm for women\n\nAt least one other of the following:\n\n* LDL- cholesterol \\>130mg/dL\n* CRP \\>1mg/L\n* Triglycerides \\>=150mg/dL\n* HDL \\<40mg/dL for men or \\<50mg/dL for women\n* Systolic blood pressure \\>= 130mmHg or diastolic \\>= 85mmHg\n* Fasting glucose \\>=100mg/dL\n\nExclusion Criteria:\n\n* Diabetes (fasting glucose \\>126mg/dL)\n* Hypertension (systolic blood pressure \\>160mmHg or diastolic blood pressure \\>100mmHg)\n* Prescribed anti-hypertensive or glucose lowering drugs\n* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease\n* Use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals\n* Pregnancy or lactation\n* Weight loss of \\>=10% of body weight within the 6 months prior to enrolling in the study\n* Vegetarianism'}, 'identificationModule': {'nctId': 'NCT03063320', 'briefTitle': 'The Effect of Spice Consumption on Postprandial Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'The Effect of Chronic Consumption of Popular Spices on Postprandial Vascular Function', 'orgStudyIdInfo': {'id': 'PKE Spice PP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Spice', 'description': 'The test meal (\\~1200kcal and 44g fat) will contain \\~0.6g of spice blend', 'interventionNames': ['Other: Spice blend']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Spice', 'description': 'The test meal (\\~1200kcal and 44g fat) will contain \\~3.7g of spice blend', 'interventionNames': ['Other: Spice blend']}, {'type': 'EXPERIMENTAL', 'label': 'Culinary Spice', 'description': 'The test meal (\\~1200kcal and 44g fat) will contain \\~7.4g of spice blend', 'interventionNames': ['Other: Spice blend']}], 'interventions': [{'name': 'Spice blend', 'type': 'OTHER', 'description': 'Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon', 'armGroupLabels': ['Culinary Spice', 'Low Spice', 'Moderate Spice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Penny M Kris-Etherton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}