Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-28 @ 11:11 PM
Study NCT ID:
NCT01190358
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2010-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Grape Seed Extract and Postprandial Oxidation and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056604', 'term': 'Grape Seed Extract'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2010-08-25', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification of the postprandial inflammatory response.', 'timeFrame': '7 hours', 'description': 'Analysis of inflammatory markers known to increase following a meal high in fat (\\~40% kcal from fat). Markers to be analyzed will include the following:\n\n1. Serum lipids\n2. Oxidized LDL\n3. Hs-CRP\n4. TNFα\n5. IL1\n6. IL6'}], 'secondaryOutcomes': [{'measure': 'Metabolic response to a high fat meal.', 'timeFrame': '7 hours', 'description': 'Assay for the insulin and glucose response generated from consumming a high fat meal (\\~40% of kcal from fat).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome.', 'detailedDescription': 'The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome. If this extract is shown to mitigate the inflammatory response induced by a high fat meal, it could potentially aid in postponing of the diagnosis of diabetes or other chronic diseases associated with high levels of inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe metabolic syndrome will be diagnosed on the basis of having a combination of any 3 of the following factors:\n\n1. Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women)\n2. Elevated triglycerides ≥150mg/dl\n3. HDL cholesterol of \\< 40mg/dl (men) or \\< 50mg/dl (women)\n4. Elevated blood pressure of ≥ 130/85mmHg\n5. Fasting glucose of \\> 100mg/dL\n\nExclusion criteria:\n\n* Smokers\n* Female subjects who are pregnant or lactating\n* Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements\n* Subjects with any known allergy or intolerance to foods involved in the study (cantaloupe, egg, dairy, wheat, grape seed extract)\n* Subjects who are actively trying to lose weight\n* Subjects with unusual dietary habits (i.e. pica, anorexia nervosa, extreme food restriction, binging and/or purging disorders)\n* Subjects who are addicted to drugs or alcohol or who are \\<1 year recovery program\n* Subjects who present with significant psychiatric or neurological disturbances as determined by the primary investigator (i.e. uncontrolled bipolar disorder)\n* Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (≥ 140/90mmHg), liver and kidney disease as identified by routine blood tests (chemistry panels). These subjects will be referred to their primary care doctor for further care.'}, 'identificationModule': {'nctId': 'NCT01190358', 'acronym': 'GSEMetS', 'briefTitle': 'Grape Seed Extract and Postprandial Oxidation and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.', 'orgStudyIdInfo': {'id': '200917488'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sugar pill', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Grape seed extract', 'description': '300mg of grape seed extract.', 'interventionNames': ['Dietary Supplement: Grape seed extract']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo, non-active components'], 'description': 'Sugar pill containing maltodextrin.', 'armGroupLabels': ['Placebo']}, {'name': 'Grape seed extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Active, Meganatural Gold®'], 'description': 'Meganatural Gold® contains 300mg of grape seed extract.', 'armGroupLabels': ['Grape seed extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '95655', 'city': 'Mather', 'state': 'California', 'country': 'United States', 'facility': 'VA Hospital, Mather', 'geoPoint': {'lat': 37.88215, 'lon': -119.85573}}], 'overallOfficials': [{'name': 'Chulani T Kappagoda, M.D., Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}