Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-31 @ 2:22 AM
Study NCT ID:
NCT01375959
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2011-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance
Sponsor:
Organization:
Raw JSON
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'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jill.crandall@einstein.yu.edu', 'phone': '718-430-3765', 'title': 'Dr. Jill Crandall', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During full 16 week study period', 'eventGroups': [{'id': 'EG000', 'title': 'Resveratrol', 'description': 'resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 8, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 8, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal liver function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal electrocardiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated PSA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'pneumonia', 'notes': 'hospitalized for bronchitis and pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post Meal Glucose Area Under the Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'Participants received resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 3 capsules (matching placebo capsule containing lactose), orally twice a day for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '508', 'spread': '88', 'groupId': 'OG000'}, {'value': '513', 'spread': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Glucose AUC following a standard mixed meal challenge AUC, Area Under a Curve. There are no "normal ranges" but a higher value is worse than a lower value.', 'unitOfMeasure': 'mg*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 38 total randomized, 35 actually received resveratrol and 36 actually received placebo.'}, {'type': 'SECONDARY', 'title': 'Insulin Sensitivity Using a Modification of the Matsuda Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'resveratrol 500 mg capsules, 3 each day for 6 weeks\n\nresveratrol: resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching placebo capsule containing lactose, 3 each day for 6 weeks\n\nPlacebo: 3 placebo capsules orally twice a day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Insulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting plasma glucose X fasting plasma insulin) (mean plasma glucose X mean plasma insulin)}. This is a unitless measure.\n\nThe Matsuda index is considered an early biomarker for metabolic dysregulation and is an effective clinical tool to define insulin sensitivity (i.e., the ability of tissues to respond to the signal of insulin) and secretory defects in individuals with impaired glucose homeostasis. The Matsuda index correlates strongly with the euglycemic insulin clamp which is a direct measure of insulin sensitivity. In the United States, it is recognized that participants who do not have insulin resistance have Matsuda Index values of \\>=2.5.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'resveratrol 500 mg capsules, 3 each day for 6 weeks\n\nresveratrol: resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching placebo capsule containing lactose, 3 each day for 6 weeks\n\nPlacebo: 3 placebo capsules orally twice a day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'c-peptide deconvolution; HOMA-B', 'unitOfMeasure': 'pmol/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peripheral Microvascular Endothelial Function Via Reactive Hyperemia-Peripheral Arterial Tonometry (RH-PAT) Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'resveratrol 500 mg capsules, 3 each day for 6 weeks\n\nresveratrol: resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching placebo capsule containing lactose, 3 each day for 6 weeks\n\nPlacebo: 3 placebo capsules orally twice a day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.02', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Reactive Hyperemia-Peripheral Arterial Tonometry (RH-PAT) index is the ratio of the average pulse amplitude in the posthyperemic phase divided by the average baseline amplitude, with normalization to the signal in the control arm to compensate for any systemic changes. RH-PAT is a non-invasive and user-independent technique used to assess peripheral microvascular endothelial function by measuring changes in digital pulse volume during reactive hyperemia. Lower RH-PAT scores are associated with flow mediated dilatation (FMD) and may predict mortality in subjects with cardiovascular (CV) risk factors including obesity, total/HDL cholesterol ratio, diabetes, smoking and dyslipidemia.', 'unitOfMeasure': 'RH-PAT Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Differentially Expressed Transcripts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Resveratrol', 'description': 'resveratrol 500 mg capsules, 3 each day for 6 weeks\n\nresveratrol: resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching placebo capsule containing lactose, 3 each day for 6 weeks\n\nPlacebo: 3 placebo capsules orally twice a day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Gene expression in skeletal muscle using RNASeq', 'unitOfMeasure': 'differentially expressed transcripts', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Resveratrol First, Then Placebo', 'description': 'resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks\n\nwash-out period for 2 weeks\n\nmatching placebo capsule containing lactose, 3 orally twice a day for 6 weeks'}, {'id': 'FG001', 'title': 'Placebo First, Then Resveratrol', 'description': 'matching placebo capsule containing lactose, 3 orally twice a day for 6 weeks\n\nwash-out period for 2 weeks\n\nresveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks'}], 'periods': [{'title': 'First Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Received Invertention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Two participants were withdrawn due to adverse events.', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Three participants were withdrawn due to adverse events.', 'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Wash-Out (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Resveratrol First', 'description': 'resveratrol 500 mg capsules, 3 each day for 6 weeks\n\nresveratrol: resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks'}, {'id': 'BG001', 'title': 'Placebo First', 'description': 'matching placebo capsule containing lactose, 3 each day for 6 weeks\n\nPlacebo: 3 placebo capsules orally twice a day for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '8', 'groupId': 'BG000'}, {'value': '67', 'spread': '6', 'groupId': 'BG001'}, {'value': '67', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2011-05-12', 'resultsFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-13', 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insulin Secretion', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'c-peptide deconvolution; HOMA-B'}, {'measure': 'Peripheral Microvascular Endothelial Function Via Reactive Hyperemia-Peripheral Arterial Tonometry (RH-PAT) Index', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Reactive Hyperemia-Peripheral Arterial Tonometry (RH-PAT) index is the ratio of the average pulse amplitude in the posthyperemic phase divided by the average baseline amplitude, with normalization to the signal in the control arm to compensate for any systemic changes. RH-PAT is a non-invasive and user-independent technique used to assess peripheral microvascular endothelial function by measuring changes in digital pulse volume during reactive hyperemia. Lower RH-PAT scores are associated with flow mediated dilatation (FMD) and may predict mortality in subjects with cardiovascular (CV) risk factors including obesity, total/HDL cholesterol ratio, diabetes, smoking and dyslipidemia.'}, {'measure': 'Number of Differentially Expressed Transcripts', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Gene expression in skeletal muscle using RNASeq'}], 'primaryOutcomes': [{'measure': 'Post Meal Glucose Area Under the Curve', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Glucose AUC following a standard mixed meal challenge AUC, Area Under a Curve. There are no "normal ranges" but a higher value is worse than a lower value.'}], 'secondaryOutcomes': [{'measure': 'Insulin Sensitivity Using a Modification of the Matsuda Index', 'timeFrame': 'end of each of two 6 week treatment periods', 'description': 'Insulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting plasma glucose X fasting plasma insulin) (mean plasma glucose X mean plasma insulin)}. This is a unitless measure.\n\nThe Matsuda index is considered an early biomarker for metabolic dysregulation and is an effective clinical tool to define insulin sensitivity (i.e., the ability of tissues to respond to the signal of insulin) and secretory defects in individuals with impaired glucose homeostasis. The Matsuda index correlates strongly with the euglycemic insulin clamp which is a direct measure of insulin sensitivity. In the United States, it is recognized that participants who do not have insulin resistance have Matsuda Index values of \\>=2.5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['resveratrol', 'glucose intolerance', 'insulin resistance', 'endothelial function'], 'conditions': ['Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': "Resveratrol is a substance found in many plants, including grapes and red wine, which is widely used as a nutritional supplement. Studies in cells and lower animals show that resveratrol has many potential benefits, including prolonging lifespan, preventing cancer and heart disease and normalization of glucose metabolism. Although use of this agent shows great promise in the treatment and/or prevention of diabetes, there have been no studies reported to date in humans. As an initial step, this proposal is for a 6 week pilot study of resveratrol treatment in older adults with impaired glucose tolerance (IGT) in order to explore its effects on post-meal blood glucose metabolism. Preliminary studies will also be conducted to explore how resveratrol works by studying cellular function (in muscle samples obtained from study participants) and by testing resveratrol's effect on blood vessel function.", 'detailedDescription': 'A. Introduction and Specific Aims Resveratrol (RSV), a plant-derived polyphenol and potential activator of the mammalian sirtuin, Sirt1, has demonstrated promising effects on insulin secretion, insulin sensitivity and glucose tolerance and has extended the lifespan of obese mice. RSV is in common use as a nutritional supplement, but formal studies in humans are limited and-in particular-the metabolic effects of RSV in humans have yet to be carefully tested. The convergence of a worldwide epidemic of diabetes combined with a marked increase in the proportion of the elderly underscore the need to develop new approaches to improve glucose intolerance. We therefore propose a study of RSV treatment in older subjects with impaired glucose tolerance (IGT) to determine if there is improvement in glucose tolerance and markers of insulin resistance, mitochondrial biogenesis and vascular function. This proposal builds on our findings in a recently-completed NIH P01 on cardiovascular disease markers in older adults with IGT. It is our hypothesis that RSV has the potential to exert important metabolic effects that can be directly and safely tested in human subjects. The growing body of pre-clinical evidence, as well as our own preliminary data, provide strong support for formal tests of RSV effects on several important metabolic parameters. These proposed studies constitute a critical step in investigating the therapeutic potential of RSV, as well as providing insight into relevant mechanisms.\n\nSpecific Aims: We propose a 6-week randomized, double-blind, placebo controlled cross-over study of RSV in older adults (age 50-80 years, n=38) with IGT, with the following aims:\n\nSpecific Aim 1: To assess the effects of RSV (2g/day) on mixed meal tolerance in subjects with age-related glucose intolerance. In our previous studies, we developed a standard mixed meal protocol to evaluate postprandial changes in glucose, insulin and lipids. We will apply this protocol to study a cohort of older adults with impaired glucose tolerance in a double-blind, placebo controlled cross-over study of RSV treatment. Metabolic outcomes will include post-meal glucose area under the curve (AUC), calculated estimates of insulin sensitivity and insulin secretion and circulating levels of free fatty acids and triglycerides. This study will be the first to document RSV effects on glucose intolerance in humans and will provide critical information needed to inform future clinical and mechanistic investigations. We hypothesize that treatment with RSV will result in improvement in mixed meal tolerance, via effects on insulin secretion, insulin action or both, in subjects with age-related glucose intolerance.\n\nSpecific Aim 2: To assess the effects of RSV on age-related decline in mitochondrial biogenesis. In animal models, RSV has been shown to enhance mitochondrial biogenesis, which may occur through activation of Sirt1, which is an important regulator of cellular energy metabolism via PGC-1α (peroxisome-proliferator-activated receptor-γ coactivator-1 alpha). We will assess this directly by measuring mitochondrial mRNA expression and DNA copy number in muscle obtained from participants after treatment with RSV compared with placebo. Studies of mitochondrial morphology and enzyme activity will be performed in collaboration with Dr. Sreekumaran Nair (Mayo Clinic), who is an expert in mitochondrial physiology. We hypothesize that treatment with RSV will result in improvement in mitochondrial number and function, which is a potential mechanism for improvement in insulin sensitivity that may occur with RSV treatment.\n\nSpecific Aim 3: To assess the effects of RSV on fasting and post-meal endothelial function. Since treatment with RSV has also been reported to have beneficial cardiovascular effects, including improved vascular reactivity, we will study in vivo endothelial function. We will use reactive hyperemia peripheral arterial tonometry to assess endothelial dependent vasodilation in study subjects before and after treatment with RSV, in both the fasting and postprandial state. Augmentation index, a measure of arterial stiffness will also be assessed. We hypothesize that chronic treatment with RSV will result in improvement in endothelial function through direct vascular effects, which may be mediated via enhanced nitric oxide availability, reduced oxidative stress and/or as a consequence of improvement in glucose metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* impaired glucose tolerance\n\nExclusion Criteria:\n\n* history of estrogen-dependent neoplasm\n* use of certain drugs: high dose statins, warfarin, antiepileptics\n* current treatment with anti-diabetes medications\n* impaired liver or kidney function'}, 'identificationModule': {'nctId': 'NCT01375959', 'acronym': 'RSV', 'briefTitle': 'Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'The Effect of Resveratrol in Older Adults With Impaired Glucose Tolerance: a Double-Blind Crossover Study', 'orgStudyIdInfo': {'id': '2010-398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resveratrol', 'description': 'resveratrol 500 mg capsules, 3 each day for 6 weeks', 'interventionNames': ['Dietary Supplement: resveratrol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'matching placebo capsule containing lactose, 3 each day for 6 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'resveratrol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['RevGenetics', 'X500 Resveratrol'], 'description': 'resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks', 'armGroupLabels': ['Resveratrol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 placebo capsules orally twice a day for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine of Yeshiva University', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Jill Crandall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jill Crandall', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}