Nctid:
NCT06236620
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10533", "name"=>"Iron", "relevance"=>"LOW"}, {"id"=>"M17768", "name"=>"Zinc", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>72}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-19", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Iron absorption", "timeFrame"=>"day 1 (before test meal) and day 17", "description"=>"Iron isotope abundance in blood samples"}, {"measure"=>"Zinc absorption", "timeFrame"=>"day 1 (before test meal) and day 5,6,7 and 8", "description"=>"Zinc isotope abundance in urine samples"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["iron absorption", "zinc absorption", "iron bio-availability", "zinc bio-availability"], "conditions"=>["Iron Absorption", "Zinc Absorption"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this project is to investigate whether the increased iron and zinc bio-accessibility values in sprouted or hydrothermally processed wheat is reflected in an increased iron and/or zinc absorption in human subjects after consuming breakfast flakes derived from such processed wheats.", "detailedDescription"=>"The study is divided into the iron and zinc study. The iron study is a randomised double-blind crossover design. 26 participants will consume the three test meal types (control wheat flakes, flakes derived from sprouted wheat and flakes derived from hydrothermally processed wheat) spiked with a specific iron isotope at three consecutive days as breakfast. The length of the study will be 17 days. The iron isotope composition in the blood of the participants will be measured on day 1 and day 17 of the study.\n\nThe zinc study is a randomised crossover design with two different meals (control wheat flakes and flakes derived from sprouted wheat or flakes derived from hydrothermally processed wheat) spiked with a specific zinc isotope. The study contains two test groups (I and II) of 26 and 10 participants, respectively. Both test groups will consume the control wheat flakes, whereas test group I will consume the flakes from sprouted wheat and group II the flakes from hydrothermally processed wheat randomised over two test days. An intravenous dose of Zn will be given on day 1 of the study and the zinc isotope composition in the urine of the participants will be measured on day 1,5,6,7 and 8 of the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* BMI range 18.5-25.0 kg/m²\n* Regular diet with 3 meals a day (at least 5 times a week)\n\nExclusion Criteria:\n\n* Intake of vitamin and/or mineral supplements during and 2 weeks before the stud\n* Intake of antibiotics 3 months prior to the study\n* Intake of medicines that have an impact on the gastrointestinal tract during and 2 weeks before the study\n* Previous or current gastrointestinal (e.g. Crohn's disease), endocrine or eating disorders or other gastrointestinal history\n* Previous or current substance/alcohol dependence or abuse (\\> 2 units per day/14 units per week)\n* Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period\n* Pregnant or lactating or wishing to become pregnant in the period of the study\n* Allergy or intolerance to wheat (coeliac disease, gluten sensitivity) or citric acid\n* Adherence to vegan or vegetarian diets or special diets (weight loss, gluten-free etc...)\n* Blood donation in the 6 months prior to the study"}, "identificationModule"=>{"nctId"=>"NCT06236620", "acronym"=>"Wheatflakes", "briefTitle"=>"Iron and Zinc Absorption in Flakes Derived From Sprouted or Hydrothermally Processed Wheat", "organization"=>{"class"=>"OTHER", "fullName"=>"KU Leuven"}, "officialTitle"=>"Iron and Zinc Absorption in Flakes Derived From Sprouted or Hydrothermally Processed Wheat", "orgStudyIdInfo"=>{"id"=>"S64419"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Control wheat flakes", "description"=>"Wheat flakes made of whole derived from unprocessed wheat", "interventionNames"=>["Dietary Supplement: Processing of wheat"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Flakes from sprouted wheat", "description"=>"Wheat flakes made of whole derived from sprouted wheat", "interventionNames"=>["Dietary Supplement: Processing of wheat"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Flakes from hydrothermally processed wheat", "description"=>"Wheat flakes made of whole derived from hydrothermally processed wheat", "interventionNames"=>["Dietary Supplement: Processing of wheat"]}], "interventions"=>[{"name"=>"Processing of wheat", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Investigating if the consumption of sprouted or hydrothermally processed wheat affects the iron and zinc absorption in humans", "armGroupLabels"=>["Control wheat flakes", "Flakes from hydrothermally processed wheat", "Flakes from sprouted wheat"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Kristin Verbeke, Prof.", "role"=>"CONTACT", "email"=>"kristin.verbeke@kuleuven.be", "phone"=>"+3216330150"}, {"name"=>"Marie Huyskens, MSc", "role"=>"CONTACT", "email"=>"marie.huyskens@kuleuven.be", "phone"=>"+32465020885"}], "overallOfficials"=>[{"name"=>"Kristin Verbeke, Prof.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"KU Leuven"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"KU Leuven", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Kristin Verbeke", "investigatorAffiliation"=>"KU Leuven"}}}}
