{
  "FullStudy":{
    "Rank":217691,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518088",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PRT002"
          },
          "Organization":{
            "OrgFullName":"Ingredion Incorporated",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Effects of a Dietary Fiber on Fecal Microbiota and Metabolism",
          "OfficialTitle":"Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 20, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 21, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ingredion Incorporated",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Focus of the Study is on Gut Health"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Low dose dietary fiber",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Dietary Fiber"
                  ]
                }
              },{
                "ArmGroupLabel":"High dose dietary fiber",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Dietary Fiber"
                  ]
                }
              },{
                "ArmGroupLabel":"No added fiber",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Dietary Fiber"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Dietary Fiber",
                "InterventionDescription":"Dietary fiber will be added to study foods",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "High dose dietary fiber",
                    "Low dose dietary fiber",
                    "No added fiber"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Metabolizable energy",
                "PrimaryOutcomeDescription":"Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy",
                "PrimaryOutcomeTimeFrame":"7 days, 3 times"
              },{
                "PrimaryOutcomeMeasure":"Fermentability",
                "PrimaryOutcomeDescription":"Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period",
                "PrimaryOutcomeTimeFrame":"One, eight-hr day, three times"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Fecal microbiota",
                "SecondaryOutcomeDescription":"Fecal samples will be collected for 7 days at the end of each treatment period and for two days during washout periods",
                "SecondaryOutcomeTimeFrame":"2 days, three times, and 7 days, three times"
              },{
                "SecondaryOutcomeMeasure":"Blood glucose",
                "SecondaryOutcomeDescription":"An indwelling catheter will be placed and blood samples will be drawn over the course of an eight-hour period, at the end of each treatment period",
                "SecondaryOutcomeTimeFrame":"For eight hours, three times"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nBody mass index from 25 to 35 kg/m2.\nWilling to consume study foods and comply with dietary exclusions and specimen collection\n\nExclusion Criteria:\n\nPregnancy\nDiabetes\nGastrointestinal disease\nRegular use of pre- or probiotics\nRecent use of antibiotics\nHigh intake of dietary fiber",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Nancy Keim, PhD",
                "OverallOfficialAffiliation":"ARS/USDA, University of California - Davis",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"USDA, ARS, Western Human Nutrition Research Center",
                "LocationCity":"Davis",
                "LocationState":"California",
                "LocationZip":"95616",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}