{
  "FullStudy":{
    "Rank":217921,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515098",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11-2075"
          },
          "Organization":{
            "OrgFullName":"University of North Carolina, Chapel Hill",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline",
          "OfficialTitle":"The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline",
          "Acronym":"BERRY"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 13, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 14, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Carol Cheatham, PhD",
            "ResponsiblePartyInvestigatorTitle":"Assistant Professor of Psychology",
            "ResponsiblePartyInvestigatorAffiliation":"University of North Carolina, Chapel Hill"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of North Carolina, Chapel Hill",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans.\n\nHypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo.\n\nHypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo.\n\nHypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass).\n\nHypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Mild Cognitive Decline"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"123",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Blueberry Group",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Freeze-dried blueberries"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo Group",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Dextrose Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"Reference Group",
                "ArmGroupType":"No Intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Freeze-dried blueberries",
                "InterventionDescription":"Wild blueberries, freeze-dried and pulverized",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Blueberry Group"
                  ]
                }
              },{
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Dextrose Placebo",
                "InterventionDescription":"Placebo developed to closely match blueberry powder.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo Group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in cognitive test performance",
                "PrimaryOutcomeTimeFrame":"Baseline, 90 days, 180 days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in body mass distribution",
                "SecondaryOutcomeTimeFrame":"Baseline, 180 days"
              },{
                "SecondaryOutcomeMeasure":"Change in oxidative stress and inflammatory markers as measured in blood and urine",
                "SecondaryOutcomeTimeFrame":"Baseline, 90 days, 180 days"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMen and women age 65 and older\nBMI between 18.5 and 34.5\nClose individual to report memory decline\n\nExclusion Criteria:\n\nHistory of central nervous system or psychiatric disorders\nDementia or Alzheimer's diagnosis\nDiabetes\nSmoking >20 cigarettes/day\nGastrointestinal/digestive disorders\nUncontrolled chronic disease",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"65 Years",
          "MaximumAge":"79 Years",
          "StdAgeList":{
            "StdAge":[
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Carol L Cheatham, Ph.D.",
                "OverallOfficialAffiliation":"University of North Carolina, Chapel Hill",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Nutrition Research Institute",
                "LocationCity":"Kannapolis",
                "LocationState":"North Carolina",
                "LocationZip":"28081",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"29523147",
                "ReferenceType":"derived",
                "ReferenceCitation":"Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"T79",
                "InterventionBrowseLeafName":"Blueberry",
                "InterventionBrowseLeafAsFound":"Blueberry",
                "InterventionBrowseLeafRelevance":"high"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"HB",
                "InterventionBrowseBranchName":"Herbal and Botanical"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000060825",
                "ConditionMeshTerm":"Cognitive Dysfunction"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000003072",
                "ConditionAncestorTerm":"Cognition Disorders"
              },{
                "ConditionAncestorId":"D000019965",
                "ConditionAncestorTerm":"Neurocognitive Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M28292",
                "ConditionBrowseLeafName":"Cognitive Dysfunction",
                "ConditionBrowseLeafAsFound":"Cognitive Decline",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4884",
                "ConditionBrowseLeafName":"Cognition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20420",
                "ConditionBrowseLeafName":"Neurocognitive Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}