{
  "FullStudy":{
    "Rank":217826,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516333",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PBRC 26026"
          },
          "Organization":{
            "OrgFullName":"Pennington Biomedical Research Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Replace Glycemic Load and Satiety Study",
          "OfficialTitle":"Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2007"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2007",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2007",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 17, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 18, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Frank Greenway",
            "ResponsiblePartyInvestigatorTitle":"Medial Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Pennington Biomedical Research Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Pennington Biomedical Research Center",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"General Mills Inc.",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.",
          "DetailedDescription":"The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Glucose Blood",
              "Glycemic Index"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "glycemic Index"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"26",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Diet 1",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"High GI; High Carb; High GL",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: High GL 107"
                  ]
                }
              },{
                "ArmGroupLabel":"Diet 2",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"High GI, Low Carb, Med GL",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Medium GL 76"
                  ]
                }
              },{
                "ArmGroupLabel":"Diet 3",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Low GI, High Carb, Med GL",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Medium GL 68"
                  ]
                }
              },{
                "ArmGroupLabel":"Diet 4",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Low GI, Low Carb, Low GL",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Low GL 48"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"High GL 107",
                "InterventionDescription":"Three meals a day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Diet 1"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Medium GL 76",
                "InterventionDescription":"Three meals a day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Diet 2"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Medium GL 68",
                "InterventionDescription":"Three meals a day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Diet 3"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Low GL 48",
                "InterventionDescription":"Three meals a day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Diet 4"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Blood Glucose over time",
                "PrimaryOutcomeDescription":"Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.",
                "PrimaryOutcomeTimeFrame":"1 month"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Visual Analog scores (VAS)",
                "SecondaryOutcomeDescription":"Hunger, satiety, and vigor will be measured by the visual analog scales.",
                "SecondaryOutcomeTimeFrame":"1 month"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nBody Mass index between 25-35 kg/m2\nFasting serum glucose\nFasting serum glucose < 125 mg/dl\nFree of chronic disease\nWilling to eat only the foods that are provided by the Center during the diet periods\nWilling to abstain from the consumption of alcohol during the diet periods\nRegularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile\nMonophasic birth control (same dose each day)\nHormone replacement therapy\nPost-menopausal (over 1 year without bleeding)\nHave had partial hysterectomy over the age of 55\ncomplete hysterectomy at any age\n\nExclusion Criteria:\n\nDocumented presence of atherosclerotic disease\nDiabetes mellitus\nRenal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease\nBody Mass Index <25 or > 35\nHistory of drug or alcohol abuse in the last year\nFor women, pregnancy, breast feeding or postpartum < 6 months\nHistory of depression or mental illness requiring treatment or medication within that last 6 months\nMultiple food allergies or significant food preferences or restrictions that would interfere with diet adherence\nLifestyle or schedule incompatible with the study protocol\nPlanned continued use of dietary supplements through the study trial\nSmoking or tobacco use",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Frank L Greenway, MD",
                "OverallOfficialAffiliation":"Pennington Biomedical Research Center",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"William Cefalu, MD",
                "OverallOfficialAffiliation":"Pennington Biomedial Research Center",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Marlene M Most, PhD, RD",
                "OverallOfficialAffiliation":"Pennington Biomedical Research Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Pennington Biomedical Research Center",
                "LocationCity":"Baton Rouge",
                "LocationState":"Louisiana",
                "LocationZip":"70808",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"22688548",
                "ReferenceType":"derived",
                "ReferenceCitation":"Liu AG, Most MM, Brashear MM, Johnson WD, Cefalu WT, Greenway FL. Reducing the glycemic index or carbohydrate content of mixed meals reduces postprandial glycemia and insulinemia over the entire day but does not affect satiety. Diabetes Care. 2012 Aug;35(8):1633-7. doi: 10.2337/dc12-0329. Epub 2012 Jun 11."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}