{
  "FullStudy":{
    "Rank":217850,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516021",
          "OrgStudyIdInfo":{
            "OrgStudyId":"YOG"
          },
          "Organization":{
            "OrgFullName":"University Hospital Tuebingen",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"How Fat Influences the Brain",
          "OfficialTitle":"Fat Intake Modulates Cerebral Blood Flow in Homeostatic and Gustatory Brain Areas in Humans"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 18, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Sabine Frank",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"University Hospital Tuebingen"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital Tuebingen",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"German Research Foundation",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"German Federation of Industrial Research Associations",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Zentrum für Ernährungsmedizin und Prävention",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"German Center for Diabetes Research",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"University of Hohenheim",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of the current study was to investigate the effect of a high versus a low fat meal (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Fat Processing in the Brain"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Fat ingestion",
              "hypothalamus",
              "insula",
              "fMRI",
              "CBF"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"11",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"high fat yoghurt intake",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"500 ml of a high fat yoghurt",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: intake of high or low fat yoghurt"
                  ]
                }
              },{
                "ArmGroupLabel":"low fat yoghurt intake",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: intake of high or low fat yoghurt"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Dietary Supplement",
                "InterventionName":"intake of high or low fat yoghurt",
                "InterventionDescription":"intake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "high fat yoghurt intake",
                    "low fat yoghurt intake"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Changes in Cerebral Blood Flow due to the high or low fat yoghurt intake after 30 minutes and 120 minutes compared to a baseline measurement 30 minutes before yoghurt intake.",
                "PrimaryOutcomeDescription":"We were interested in differential brain activations due to the high or low fat meal. To assess this, the mentioned time points are suitable.\n\nThe Cerebral Blood Flow is measured using Arterial Spin Labeling sequences in a functional magnetic resonance tomography.",
                "PrimaryOutcomeTimeFrame":"30 minutes before as well as 30 minutes and 120 minutes after fat intake"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nmale\nhealthy\n\nExclusion Criteria:\n\nlactose intolerance\nfMRI contraindications (metal implants,...)",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"25 Years",
          "MaximumAge":"32 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University Clinic of Tuebingen, MEG Center",
                "LocationCity":"Tuebingen",
                "LocationZip":"72076",
                "LocationCountry":"Germany"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"22572644",
                "ReferenceType":"derived",
                "ReferenceCitation":"Frank S, Linder K, Kullmann S, Heni M, Ketterer C, Cavusoglu M, Krzeminski A, Fritsche A, Häring HU, Preissl H, Hinrichs J, Veit R. Fat intake modulates cerebral blood flow in homeostatic and gustatory brain areas in humans. Am J Clin Nutr. 2012 Jun;95(6):1342-9. doi: 10.3945/ajcn.111.031492. Epub 2012 May 9."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}