Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT01889368
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Grape Seed Extract (GSE) on Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056604', 'term': 'Grape Seed Extract'}, {'id': 'C008315', 'term': 'maltodextrin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-26', 'studyFirstSubmitDate': '2012-10-10', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in insulin resistance', 'timeFrame': 'Baseline and 30 days', 'description': 'Insulin resistance will be assessed by comparing the baseline fasting insulin concentration to the fasting insulin concentration after intervention period of 30 days; the Homeostatic Model Assessment (HOMA) value will be utilized for comparisons.'}], 'secondaryOutcomes': [{'measure': 'Changes in oxidized LDL (oxLDL) concentrations', 'timeFrame': 'Baseline and 24 hour post-prandial response', 'description': 'Changes in oxLDL concentrations will be assessed by ELISA methodology. Changes in the 24 hour post-prandial response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals.'}, {'measure': 'Changes in oxidative stress', 'timeFrame': 'Baseline and 24 hour post-prandial response', 'description': 'Changes in the 24 hour post-prandial oxidative stress response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. Changes in oxidative stress will be assessed by measuring cytokine production using ELISA methodology.'}, {'measure': 'Changes in vascular stress', 'timeFrame': 'Baseline and 1 hour post-prandial', 'description': 'Changes in oxidative stress will be assessed by flow mediated dialysis (FMD). Changes will be assessed at baseline and one hour after capsule consumption and eating a high fat breakfast meal.'}, {'measure': 'Changes in insulin response', 'timeFrame': 'Baseline and 24 hour post-prandial response', 'description': 'Changes in the 24 hour post-prandial insulin response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals.'}, {'measure': 'Changes in oxidized LDL (oxLDL) concentrations', 'timeFrame': 'Baseline and 30 days', 'description': 'Changes in oxLDL concentrations will be assessed by ELISA methodology. Changes in the 24 hour post-prandial response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. The response from the baseline visit will be compared to the response obtained during the day 30 visit.'}, {'measure': 'Changes in insulin response', 'timeFrame': 'Baseline and 30 days', 'description': 'Changes in the 24 hour post-prandial insulin response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. The response from the baseline visit will be compared to the response obtained during the day 30 visit.'}, {'measure': 'Changes in oxidative stress', 'timeFrame': 'Baseline and 30 days', 'description': 'Changes in the 24 hour post-prandial oxidative stress response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. Changes in oxidative stress will be assessed by measuring cytokine production using ELISA methodology. The response from the baseline visit will be compared to the response obtained during the 30 day visit.'}, {'measure': 'Changes in vascular stress', 'timeFrame': 'Baseline and 30 days', 'description': 'Changes in oxidative stress will be assessed by flow mediated dialysis (FMD). Changes will be assessed at baseline and one hour after capsule consumption and eating a high fat breakfast meal. Results obtained during the first post-prandial study visit will be compared to those obtained 30 days later.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin resistance', 'Central adiposity', 'Elevated blood pressure', 'Vascular reactivity', 'Elevated triglycerides', 'Low high-density lipoprotein (HDL)'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'In people with the metabolic syndrome, the investigators hypothesize that administration of a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized LDL in the blood during a 24 hour period. These measurements will be assessed at hourly intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin resistance, oxidative stress, and the level of oxidized LDL in the blood.', 'detailedDescription': 'In people with the metabolic syndrome, the investigators hypothesize that administration of a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized LDL in the blood during a 24 hour period. Each of these can be elevated after eating high fat meals, which are commonly found in the average Western diet. To better assess the impact of these high fat eating patterns, three standardized high fat meals will be served during the study day: breakfast, lunch, and dinner. Measurements in the blood will be assessed at hourly intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin resistance, oxidative stress, and the level of oxidized LDL in the blood when this 24 hour study day protocol is repeated and breakfast, lunch, and dinner are again served.\n\nInsulin resistance will be measured using a comparison of insulin and glucose levels in the blood. Oxidative stress, a measure of inflammation, will be measured by cytokines levels in the blood. The level of oxidized LDL will be measured in the blood. The investigators also plan to undertake a subsidiary pharmacokinetic study on the various polymers which are known to be present in grape seed extracts to determine their bio-availability and their relationship to the biological effects observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Metabolic Syndrome, based on subject meeting at least 3 of the following criteria:\n* Abdominal obesity with waist circumference \\> 40 inches in men or \\> 35 inches in women,\n* Pre-hypertension with blood pressure \\> 135/85,\n* Fasting blood glucose levels above 110 mg/dl,\n* Plasma triglyceride levels in excess of 150 mg/dl,\n* HDL levels below 40 mg/dl in men or 50 mg/dl in women.\n\nExclusion Criteria:\n\n* Any known systemic disease,\n* Diabetes,\n* Alcohol consumption \\> 1-2 drinks/week,\n* Taking any medications or supplements that will affect metabolism, their ability to exercise or oxidative status,\n* Smokers,\n* Female subjects having abnormal menstrual cycles, taking oral contraceptives, pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT01889368', 'briefTitle': 'Effect of a Grape Seed Extract (GSE) on Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Effect of a Grape Seed Extract (GSE) on Insulin Resistance', 'orgStudyIdInfo': {'id': '329493'}, 'secondaryIdInfos': [{'id': '329493-4', 'type': 'OTHER', 'domain': 'UC Davis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Grape Seed Extract', 'description': 'This is a 30 day arm. At the baseline study visit, subjects will consume one 300 mg capsule of MegaNatural Gold followed by 3 high fat meals: breakfast, lunch, and dinner. Blood will be drawn at specified intervals throughout the day. Flow mediated dialysis will be performed before breakfast and again 1.5 hours later, after capsule consumption and breakfast. A minimum 14 day washout period will be between arms if this is the first arm in the randomized cross-over.', 'interventionNames': ['Dietary Supplement: Grape Seed Extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This is a 30 day arm. At the baseline study visit, subjects will consume one placebo (maltodextrin) capsule followed by 3 high fat meals: breakfast, lunch, and dinner. Blood will be drawn at specified intervals throughout the day. Flow mediated dialysis will be performed before breakfast and again 1.5 hours later, after capsule consumption and breakfast. A minimum 14 day washout period will be between arms if this is the first arm in the randomized cross-over.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Grape Seed Extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['MegaNatural Gold'], 'description': '300 mg capsule of Grape Seed Extract; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.', 'armGroupLabels': ['Grape Seed Extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Maltodextrin'], 'description': '300 mg capsule of maltodextrin; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'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, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Illinois Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}