Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT06683534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palmitic Acid and Human Microvascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011794', 'term': 'Quercetin'}, {'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized to receive the supplement quercetin or placebo for 30 days to determine its effect on microvascular function.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2024-11-08', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood vessel dilation', 'timeFrame': '2 hours', 'description': 'Peripheral microvascular dilation in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be measured using laser Doppler flowmetry with microdialysis.'}], 'secondaryOutcomes': [{'measure': 'Change in Perfused Vessel Density', 'timeFrame': '0.5 hours', 'description': 'Total vessel density (TVD) will be calculated using the DeBacker Score manual analysis on all images that have a minimum microcirculation image quality score (MIQS) of 10. Perfused vessel density (PVD) will be calculated by multiplying total vessel density (TVD) x proportion of perfused vessels (PPV%).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Supplement'], 'conditions': ['Microvascular Dysfunction', 'Microvasculature', 'Cardiovascular Diseases', 'Cardiovascular Diseases (CVD)', 'Microvascular Health', 'Obesity and Overweight']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to learn how a supplement Quercetin can affect microvascular function.\n\nParticipants will:\n\n* give two blood draws of 5 mL each\n* have a camera placed under the tongue to take pictures of blood vessels\n* have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion\n\nResearchers will compare blood vessel function of those who take estrogen supplements to those who do not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity (BMI\\>30)\n* Aged 18-40 years\n* English Speaking\n\nExclusion Criteria:\n\n* BMI\\>60\n* Resting SBP ≥180 mmHg or DBP ≥ 110mmHg\n* Pregnancy or breastfeeding.\n* Prior history of myocardial infarction\n* Diagnosis of more than 1 risk factor for coronary artery disease (active smoker, diabetes mellitus- type 1 or 2, congestive heart failure, hyperlipidemia, hypertension)\n* Active mouth sores that affect the buccal mucosa.'}, 'identificationModule': {'nctId': 'NCT06683534', 'briefTitle': 'Palmitic Acid and Human Microvascular Function', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Use of Quercetin to Increase Resiliency to Palmitic Acid in the Human Microvasculature', 'orgStudyIdInfo': {'id': 'PRO00053081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of oral quercetin to improve human microvascular function', 'description': 'Quercetin is a non-FDA approved, over-the-counter supplement that has been shown to improve oxidative capacity in blood vessels.', 'interventionNames': ['Dietary Supplement: Quercetin (dietary supplement)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "A placebo will be administered for 30 days followed by assessment of the subject's microvascular function.", 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Quercetin (dietary supplement)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Quercetin will be provided to take one Quercetin per day for 30 days to look for differences in microvascular function.', 'armGroupLabels': ['Use of oral quercetin to improve human microvascular function']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects randomized to receive placebo will be administered a standard placebo sugar pill.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Julia Vogt', 'role': 'CONTACT', 'email': 'jvogt@mcw.edu', 'phone': '4149552348'}, {'name': 'Julie Freed, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Froedtert Hospital', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'centralContacts': [{'name': 'Julia A Vogt', 'role': 'CONTACT', 'email': 'jvogt@mcw.edu', 'phone': '4149552348'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Vice Chair', 'investigatorFullName': 'Julie K. Freed', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}