{
  "FullStudy":{
    "Rank":217722,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517685",
          "OrgStudyIdInfo":{
            "OrgStudyId":"20111700"
          },
          "Organization":{
            "OrgFullName":"Hallelujah Acres",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Hallelujah Acres Omega 3 Fat Study",
          "OfficialTitle":"Hallelujah Acres Omega 3 Fat Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 17, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 19, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hallelujah Acres",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This research is being done to study the effect of taking flax seed oil and fish oil on blood lipids in vegetarians following the Hallelujah Diet. Omega 3 fats are important to our health and we want to see how effective both flax seed oil and fish oil are in raising your Omega 3 Score (higher is better). The Omega 3 Score is one of many indicators that may show your personal risk of dying suddenly from a heart attack.",
          "DetailedDescription":"This study is being conducted to compare the response of individuals to flax seed oil or fish oil, measured by blood lipids. Especially the amount of the long chain omega 3 polyunsaturated fats EPA and DHA will be tested. An omega 3 score for whole blood will be measured. The omega 3 score is the percent sum of omega 3 fats in the blood.\n\nThe hypothesis is that 5 grams of fish oil will increase the amount of EPA and DHA in a person's blood to a protective level, and that 30 grams (2 tablespoons) of flax oil will not change the blood levels of EPA significantly and not change the blood concentrations of DHA at all, even for a person consuming a low omega 6 oil diet and following a vegan diet high in fruits and vegetables.\n\nMost of the testing of flax and fish oil has not been done in vegans. This trial will extend this testing to this subpopulation."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Omega 3 Fat Status"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Eicosapentaenoic acid",
              "EPA",
              "Docosahexaenoic acid",
              "DHA",
              "Omega 3 fat",
              "alpha-linoleic acid",
              "ALA",
              "fish oil",
              "flax seed oil"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"13",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Flax Oil and then Fish Oil",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"All people in the study will use the flax seed oil and then the fish oil.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Dietary Supplement: Organic flax seed oil",
                    "Dietary Supplement: fish oil"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Dietary Supplement",
                "InterventionName":"Organic flax seed oil",
                "InterventionDescription":"2 tablespoons of organic flax seed oil are eaten daily for 8 weeks.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Flax Oil and then Fish Oil"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Flora Flax Oil, organic."
                  ]
                }
              },{
                "InterventionType":"Dietary Supplement",
                "InterventionName":"fish oil",
                "InterventionDescription":"5 grams (1 tsp.) of fish oil is eaten per day for 8 weeks.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Flax Oil and then Fish Oil"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Pharmax LLC Finest Pure Fish Oil"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Omega 3 Score",
                "PrimaryOutcomeDescription":"A finger prick blood sample is analyzed for fatty acids, including the amount of omega 3 fats in the blood. The Omega 3 Score is the amount of EPA and DHA in whole blood as a percent of fat.",
                "PrimaryOutcomeTimeFrame":"8 weeks of supplementation before testing"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMust have followed the Hallelujah Diet (or very similar diet) for at least the last two years,\nMust have stable body weight (not gained or lost more than 5 pounds of weight over the last three months)\n\nExclusion Criteria:\n\nPregnancy (all pregnant women should take fish oil, not flax seed oil)\nCurrently using fish oil, or flax seed oil,EPA, DHA, or flax seed oil with added DHA\nEating more than 2 teaspoons of flax seed per day\nDiabetes (fish oil may affect blood sugar levels)\nGenerally poor health",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Michael Donaldson, PhD",
                "OverallOfficialAffiliation":"Hallelujah Acres",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hallelujah Acres Research Office / Laboratory",
                "LocationCity":"Zillah",
                "LocationState":"Washington",
                "LocationZip":"98953",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"T156",
                "InterventionBrowseLeafName":"Flax",
                "InterventionBrowseLeafAsFound":"Flax",
                "InterventionBrowseLeafRelevance":"high"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"HB",
                "InterventionBrowseBranchName":"Herbal and Botanical"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}