{
  "FullStudy":{
    "Rank":217842,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516125",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IRB00016822"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"P50AT002782",
                "SecondaryIdType":"U.S. NIH Grant/Contract",
                "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P50AT002782&Fy=all"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Wake Forest University Health Sciences",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing",
          "OfficialTitle":"Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2020",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2020",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 6, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 9, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Wake Forest University Health Sciences",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Center for Complementary and Integrative Health (NCCIH)",
                "CollaboratorClass":"NIH"
              },{
                "CollaboratorName":"Office of Dietary Supplements (ODS)",
                "CollaboratorClass":"NIH"
              },{
                "CollaboratorName":"University of Arizona",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes",
          "IsFDARegulatedDrug":"No",
          "IsFDARegulatedDevice":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this research study is to screen healthy African American and Caucasian persons for specific differences in genes that control how fats are processed in the body.",
          "DetailedDescription":"Healthy African American and Caucasian persons will be screened for specific differences in genes that control how fats are processed in the body. Persons with the needed genotypes will be added to a database of healthy persons who may be asked to join a larger study comparing differences in diet on lipid metabolism and inflammatory biomarkers as well as future studies. A key hypothesis for the larger study is that variations in genes involved in lipid metabolism play a role in determining levels of long chain polyunsaturated fatty acids (LC-PUFAs)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "healthy adult",
              "genetic variation",
              "botanical oils",
              "polyunsaturated fatty acid",
              "fish oil",
              "fat metabolism",
              "Genetic variation of fat metabolism in healthy adults"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Cross-Sectional"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"A small saliva sample for screening purposes will be collected. If documentation from a personal physician of blood glucose and lipid levels are unavailable, we will collect a small tube (10-12 ml) of blood to determine these measurements."
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"800",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Screening only - no intervention"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster",
                "PrimaryOutcomeTimeFrame":"up to 52 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nBe Caucasian or African American between 21-65 years of age\nBe healthy and free of any major illness\nBe a nonsmoker\nHave an intact gallbladder\nHave TG < 150 and blood pressure less than 130/90\nMust be willing to be re-contacted for future studies\n\nExclusion Criteria:\n\nNot have: myocardial infarction, vascular surgery or stroke within the past year\nNot be taking niacin, more than 100 mg aspirin/day or montelukast allergy medications\nBMI equal to or greater than 30 or less than 19\nFasting glucose greater than 125 mg/dl\nPregnancy",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"21 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Caucasian or African American adults between 21 and 65 years of age",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Priscilla Ivester, M.A.",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"336-716-7388",
                "CentralContactEMail":"ivester@wakehealth.edu"
              },{
                "CentralContactName":"Tammy C Lee, M.S.",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"336-716-7388",
                "CentralContactEMail":"talee@wakehealth.edu"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Susan Sergeant, Ph.D.",
                "OverallOfficialAffiliation":"Wake Forest University Heath Sciences",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Wake Forest Health Sciences",
                "LocationStatus":"Recruiting",
                "LocationCity":"Winston-Salem",
                "LocationState":"North Carolina",
                "LocationZip":"27157",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Priscilla Ivester, M.A.",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"336-716-7388",
                      "LocationContactEMail":"ivester@wakehealth.edu"
                    },{
                      "LocationContactName":"Tammy Lee, M.S.",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"336-716-7388",
                      "LocationContactEMail":"talee@wakehealth.edu"
                    },{
                      "LocationContactName":"Susan Sergeant, Ph.D.",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No",
          "IPDSharingDescription":"This is a screening (one visit) to recruit healthy people for genotyping and re-contact for future studies"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}