{
  "FullStudy":{
    "Rank":217640,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518764",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NL37147.029.11"
          },
          "Organization":{
            "OrgFullName":"VU University Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Effects of Red Wine Polyphenols on Microvascular Dysfunction",
          "OfficialTitle":"The Effects of Red Wine Polyphenols on Microvascular Dysfunction"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 2, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 24, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 25, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Erik Serne",
            "ResponsiblePartyInvestigatorTitle":"MD phd",
            "ResponsiblePartyInvestigatorAffiliation":"VU University Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"VU University Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Rationale:\n\nEpidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. Beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. Experimental studies with mixed or separate Red Wine Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. Most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce\n\nObjective:\n\nTo study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.\n\nStudy design:\n\nRandomized controlled trial (double blind).\n\nStudy population:\n\nObese (BMI >30); n=30, men or women, aged 18-60 years.\n\nIntervention:\n\nMixed RWP 600mg/day or matching placebo for a total duration of 8 weeks."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Obesity"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"29",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Red Wine Polyphenols",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Red Wine Polyphenols 600mg/day (capsules)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Red Wine Polyphenols 600mg/day"
                  ]
                }
              },{
                "ArmGroupLabel":"placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"placebo (capsules)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Red Wine Polyphenols 600mg/day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Red Wine Polyphenols"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Provinols™"
                  ]
                }
              },{
                "InterventionType":"Dietary Supplement",
                "InterventionName":"placebo",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"insulin sensitivity as determined by euglycemic clamp tests",
                "PrimaryOutcomeTimeFrame":"8 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Molecular mechanisms in muscle tissue",
                "SecondaryOutcomeTimeFrame":"8 weeks"
              },{
                "SecondaryOutcomeMeasure":"Glucose tolerance as assessed by the area under the curve for glucose (AUCgluc) during a standardized meal test",
                "SecondaryOutcomeTimeFrame":"8 weeks"
              },{
                "SecondaryOutcomeMeasure":"microvascular function (baseline and during hyperglycemia)",
                "SecondaryOutcomeTimeFrame":"8 weeks"
              },{
                "SecondaryOutcomeMeasure":"Blood pressure 24 hr measurement",
                "SecondaryOutcomeTimeFrame":"8 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nCaucasian\nage 18-60 years\nobese (BMI >30)\n\nExclusion Criteria:\n\ncardiovascular disease\nsmoking\ndiabetes mellitus\nrecent history (<12 months) of high alcohol use > 4 U/day\nuse of medication potentially affection insulin sensitivity or microvascular function\npregnancy",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Erik Serne, MD PhD",
                "OverallOfficialAffiliation":"VUmc, internal medicine",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"VUMedicalCenter",
                "LocationCity":"Amsterdam",
                "LocationState":"Noord-Holland",
                "LocationZip":"1081 HV",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"28643477",
                "ReferenceType":"derived",
                "ReferenceCitation":"Woerdeman J, Del Rio D, Calani L, Eringa EC, Smulders YM, Serné EH. Red wine polyphenols do not improve obesity-associated insulin resistance: A randomized controlled trial. Diabetes Obes Metab. 2018 Jan;20(1):206-210. doi: 10.1111/dom.13044. Epub 2017 Aug 14."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}