<ddi:DDIInstance xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:instance:3_3 http://ddialliance.org/Specification/DDI-Lifecycle/3.3/XMLSchema/instance.xsd" xmlns:xsd="http://www.w3.org/2001/XMLSchema" xmlns:ddi="ddi:instance:3_3" xmlns:r="ddi:reusable:3_3" xmlns:s="ddi:studyunit:3_3" xmlns:d="ddi:datacollection:3_3" xmlns:a="ddi:archive:3_3" xmlns:c="ddi:conceptualcomponent:3_3" xmlns:cm="ddi:comparative:3_3" xmlns:g="ddi:group:3_3" xmlns:l="ddi:logicalproduct:3_3" xmlns:p="ddi:physicaldataproduct:3_3" xmlns:pi="ddi:physicalinstance:3_3" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:xhtml="http://www.w3.org/1999/xhtml" xmlns:xml="http://www.w3.org/XML/1998/namespace" isMaintainable="true" scopeOfUniqueness="Agency">
  <r:URN>urn:ddi:se.researchdata:snd0015-1:1</r:URN>
  <r:Agency>SND</r:Agency>
  <r:ID>snd0015-1</r:ID>
  <r:Version>1</r:Version>
  <g:ResourcePackage>
    <r:URN>urn:ddi:se.researchdata:snd0015-1.ResourcePackage:2.0</r:URN>
    <r:OtherMaterialScheme>
      <r:URN>urn:ddi:se.researchdata:snd0015-1.OtherMaterialScheme:2.0</r:URN>
    </r:OtherMaterialScheme>
    <a:OrganizationScheme>
      <r:URN>urn:ddi:se.researchdata:snd0015-1.OrganizationScheme-0:2.0</r:URN>
      <a:Individual>
        <r:URN>urn:ddi:se.researchdata:snd0015-1.Individual-0:2.0</r:URN>
        <a:IndividualIdentification>
          <a:IndividualName>
            <a:FirstGiven>Dag</a:FirstGiven>
            <a:LastFamily>Thelle</a:LastFamily>
            <a:FullName>
              <r:String>Dag Thelle</r:String>
            </a:FullName>
          </a:IndividualName>
        </a:IndividualIdentification>
      </a:Individual>
      <a:Individual>
        <r:URN>urn:ddi:se.researchdata:snd0015-1.Individual-0:2.0</r:URN>
        <r:UserAttributePair>
          <r:AttributeKey>affiliation</r:AttributeKey>
          <r:AttributeValue>Department of Public Health and Community Medicine, University of Gothenburg</r:AttributeValue>
        </r:UserAttributePair>
        <a:IndividualIdentification>
          <a:IndividualName>
            <a:FirstGiven>Elisabeth</a:FirstGiven>
            <a:LastFamily>Strandhagen</a:LastFamily>
            <a:FullName>
              <r:String>Elisabeth Strandhagen</r:String>
            </a:FullName>
          </a:IndividualName>
        </a:IndividualIdentification>
      </a:Individual>
      <a:Individual>
        <r:URN>urn:ddi:se.researchdata:snd0015-1.Individual-0:2.0</r:URN>
        <r:UserAttributePair>
          <r:AttributeKey>affiliation</r:AttributeKey>
          <r:AttributeValue>Institute of Neuroscience and Physiology, University of Gothenburg</r:AttributeValue>
        </r:UserAttributePair>
        <a:IndividualIdentification>
          <a:IndividualName>
            <a:FirstGiven>Henrik</a:FirstGiven>
            <a:LastFamily>Zetterberg</a:LastFamily>
            <a:FullName>
              <r:String>Henrik Zetterberg</r:String>
            </a:FullName>
          </a:IndividualName>
        </a:IndividualIdentification>
      </a:Individual>
    </a:OrganizationScheme>
  </g:ResourcePackage>
  <s:StudyUnit>
    <r:URN>urn:ddi:se.researchdata:snd0015-1.StudyUnit:2.0</r:URN>
    <r:UserID typeOfUserID="datasetIdentifier">snd0015-1</r:UserID>
    <r:Citation>
      <r:Title>
        <r:String xml:lang="sv">Kaffe, homocystein och B-vitaminer</r:String>
        <r:String xml:lang="en">Coffee, homocysteine and B vitamins</r:String>
      </r:Title>
      <r:Creator>
        <r:CreatorReference>
          <r:URN>urn:ddi:se.researchdata:snd0015-1.Individual-0:2.0</r:URN>
          <r:TypeOfObject>Individual</r:TypeOfObject>
        </r:CreatorReference>
      </r:Creator>
      <r:Publisher>
        <r:PublisherName>
          <r:String xml:lang="sv">Göteborgs universitet</r:String>
          <r:String xml:lang="en">University of Gothenburg</r:String>
        </r:PublisherName>
      </r:Publisher>
      <r:Publisher>
        <r:PublisherName>
          <r:String xml:lang="sv">Göteborgs universitet</r:String>
          <r:String xml:lang="en">University of Gothenburg</r:String>
        </r:PublisherName>
      </r:Publisher>
      <r:PublicationDate>
        <r:SimpleDate>2011-01-01</r:SimpleDate>
      </r:PublicationDate>
    </r:Citation>
    <r:Abstract>
      <r:Content xml:lang="sv">Studien gjordes som ett doktorandprojekt vid Göteborgs Universitet med bakgrund i att förhöjd nivå av homocystein har satts i samband med ökt risk för hjärt-kärl-sjukdom. De viktigaste faktorerna som höjer homocysteinnivån i blodet är lågt intag av B-vitaminer (framförallt folsyra), rökning och kaffe. En randomiserad placebo kontrollerad interventionstudie gjordes för att se om supplementering med folat (delstudie 1) eller vitamin B6 (delstudie 2) kunde eliminera homocysteinökningen som uppkommer av normala doser kaffe.   Studien genomfördes som två prospektiva, randomiserade, dubbelblinda kontrollerade försök.  Försökspersonerna randomiserades till två grupper enligt följande:  1) Under 3 veckor: Båda grupperna: inget kaffe  2) Under 4 veckor: Grupp A: 6 dl kaffe/dygn + 200 mikrog folat/dygn, Grupp B: 6 dl kaffe/dygn + placebo  3) Under 3 veckor: Båda grupperna: inget kaffe  4) Under 4 veckor: Grupp A: 6 dl kaffe/dygn + 40 mg vitB6/dygn, Grupp B: 6 dl kaffe/dygn + placebo.  Vid början av delstudie 2 randomiserades deltagarna på nytt. Vid första besöket genomfördes en kostundersökning med speciell inriktning på folat- och vitB6-innehållande livsmedel. Kostvanorna registrerades även under studiens gång. Blodprov och blodtryck togs vid alla 5 tillfällen. Under studien drack försökspersonerna endast den mängd kaffe som anges ovan. Eventuella avvik registrerades. Andra drycker fick konsumeras fritt. Blodproverna som togs vid varje besökstillfälle analyserades avseende homocystein i plasma och total kolesterol, HDL-kolesterol, triglycerider, Lp(a), folat, ASAT, ALAT, urat och gamma-GT i serum. Helblod finns fryst.

Syfte:

Att studera interaktionen mellan kaffekonsumtion och effekten av folat och vitamin B6 på metioninmetabolismen och därigenom effekten på plasma homocystein.</r:Content>
      <r:Content xml:lang="en">Elevated level of homocysteine has been identified as a graded and independent risk factor for coronary heart disease. The metabolism of homocysteine is dependent on the availability of the B-vitamins, folate, vitamin B12, and vitamin B6 (pyridoxal phosphate). Although elevated levels of tHcy in plasma and serum is particularly seen in folate deficiency, elevated levels are also seen in the presence of folate levels in the lower reference range.  The study was organised as a prospective, cross-over, blinded controlled trial with the participants randomly allocated to two different groups which will consume:  


 1) For 3 weeks: Both groups: no coffee  


 2) For 4 weeks: Group A: 4 cups of coffee/day + placebo, Group B: 4 cups of coffee/day + 200 g folate/day 


 3) For 3 weeks: Both groups: no coffee (wash out) 


 4) For 4 weeks: Group A. 4 cups of coffee/day + 40 g B-6/day, Group B: 4 cups of coffee/day + placebo.


 The participants were randomised again in the beginning of the second part. Each participant met at five visits. They were allowed to drink other beverages. Diet habits were registered during the study. Blood samples were drawn and blood pressure measured at every visit. Blood samples were analysed for homocysteine in plasma and total cholesterol, HDL-cholesterol, triglycerides, Lp(a), folate, ALAT, ASAT, urate and gamma-GT in serum. Frosen whole blood is available.

Purpose:

To investigate the interaction of coffee consumption on the effects of folate and vitamin B-6 on the methionin metabolism and thereby on the plasma homocysteine levels.</r:Content>
    </r:Abstract>
    <r:Coverage>
      <r:TopicalCoverage>
        <r:URN>urn:ddi:se.researchdata:snd0015-1.TopicalCoverage:2.0</r:URN>
        <r:Subject xml:lang="en" controlledVocabularyID="Health" controlledVocabularyName="CESSDA Topic Classification">HEALTH</r:Subject>
        <r:Subject xml:lang="sv" controlledVocabularyID="Health" controlledVocabularyName="CESSDA Topic Classification">HÄLSA</r:Subject>
        <r:Subject xml:lang="en" controlledVocabularyID="Health.SpecificDiseasesDisordersAndMedicalConditions" controlledVocabularyName="CESSDA Topic Classification">Specific diseases, disorders and medical conditions</r:Subject>
        <r:Subject xml:lang="sv" controlledVocabularyID="Health.SpecificDiseasesDisordersAndMedicalConditions" controlledVocabularyName="CESSDA Topic Classification">Specifika sjukdomar, störningar och medicinska tillstånd</r:Subject>
        <r:Subject xml:lang="en" controlledVocabularyID="30206" controlledVocabularyName="Standard för svensk indelning av forskningsämnen 2025">Cardiology and Cardiovascular Disease</r:Subject>
        <r:Subject xml:lang="sv" controlledVocabularyID="30206" controlledVocabularyName="Standard för svensk indelning av forskningsämnen 2025">Kardiologi och kardiovaskulära sjukdomar</r:Subject>
        <r:Subject xml:lang="en" controlledVocabularyID="30304" controlledVocabularyName="Standard för svensk indelning av forskningsämnen 2025">Nutrition and Dietetics</r:Subject>
        <r:Subject xml:lang="sv" controlledVocabularyID="30304" controlledVocabularyName="Standard för svensk indelning av forskningsämnen 2025">Näringslära och dietkunskap</r:Subject>
        <r:Keyword xml:lang="en" controlledVocabularyID="D001794" controlledVocabularyName="MeSH">Blood Pressure</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D001794" controlledVocabularyName="MeSH">Blodtryck</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D001800" controlledVocabularyName="MeSH">Blood Specimen Collection</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D001800" controlledVocabularyName="MeSH">Blodprovstagning</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D006710" controlledVocabularyName="MeSH">Homocysteine</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D006710" controlledVocabularyName="MeSH">Homocystein</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D000410" controlledVocabularyName="MeSH">Alanine Transaminase</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D000410" controlledVocabularyName="MeSH">Alanintransaminas</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D001219" controlledVocabularyName="MeSH">Aspartate Aminotransferases</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D001219" controlledVocabularyName="MeSH">Aspartataminotransferaser</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D005492" controlledVocabularyName="MeSH">Folic Acid</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D005492" controlledVocabularyName="MeSH">Folsyra</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D005723" controlledVocabularyName="MeSH">gamma-Glutamyltransferase</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D005723" controlledVocabularyName="MeSH">Gammaglutamyltransferas</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D005796" controlledVocabularyName="MeSH">Genes</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D005796" controlledVocabularyName="MeSH">Gener</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D002318" controlledVocabularyName="MeSH">Cardiovascular Diseases</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D002318" controlledVocabularyName="MeSH">Kardiovaskulära sjukdomar</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D003069" controlledVocabularyName="MeSH">Coffee</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D003069" controlledVocabularyName="MeSH">Kaffe</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D002784" controlledVocabularyName="MeSH">Cholesterol</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D002784" controlledVocabularyName="MeSH">Kolesterol</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D019587" controlledVocabularyName="MeSH">Dietary Supplements</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D019587" controlledVocabularyName="MeSH">Kosttillskott</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D001827" controlledVocabularyName="MeSH">Body Height</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D001827" controlledVocabularyName="MeSH">Kroppslängd</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D001835" controlledVocabularyName="MeSH">Body Weight</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D001835" controlledVocabularyName="MeSH">Kroppsvikt</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D052756" controlledVocabularyName="MeSH">Nutritional Sciences</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D052756" controlledVocabularyName="MeSH">Näringsvetenskap</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D010919" controlledVocabularyName="MeSH">Placebos</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D010919" controlledVocabularyName="MeSH">Placebo</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D012907" controlledVocabularyName="MeSH">Smoking</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D012907" controlledVocabularyName="MeSH">Rökning</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D014280" controlledVocabularyName="MeSH">Triglycerides</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D014280" controlledVocabularyName="MeSH">Triglycerider</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D014527" controlledVocabularyName="MeSH">Uric Acid</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D014527" controlledVocabularyName="MeSH">Urinsyra</r:Keyword>
        <r:Keyword xml:lang="en" controlledVocabularyID="D014803" controlledVocabularyName="MeSH">Vitamin B Complex</r:Keyword>
        <r:Keyword xml:lang="sv" controlledVocabularyID="D014803" controlledVocabularyName="MeSH">B-vitamin komplex</r:Keyword>
      </r:TopicalCoverage>
      <r:SpatialCoverage>
        <r:URN>urn:ddi:se.researchdata:snd0015-1.SpatialCoverage:2.0</r:URN>
        <r:Description>
          <r:Content xml:lang="sv">Stor-Göteborg</r:Content>
        </r:Description>
        <r:CountryCode>SE</r:CountryCode>
      </r:SpatialCoverage>
      <r:TemporalCoverage>
        <r:URN>urn:ddi:se.researchdata:snd0015-1.TemporalCoverage:2.0</r:URN>
        <r:ReferenceDate>
          <r:StartDate>2000-10</r:StartDate>
          <r:EndDate>2001-04</r:EndDate>
        </r:ReferenceDate>
      </r:TemporalCoverage>
    </r:Coverage>
    <r:AnalysisUnit controlledVocabularyID="AnalysisUnit" controlledVocabularyAgencyName="DDI Alliance">Individual<r:ControlledVocabularyURN>http://rdf-vocabulary.ddialliance.org/cv/AnalysisUnit/2.1.3/2dd4472</r:ControlledVocabularyURN></r:AnalysisUnit>
    <r:AnalysisUnitsCovered>
      <r:String xml:lang="en">Individual</r:String>
      <r:String xml:lang="sv">Individ</r:String>
    </r:AnalysisUnitsCovered>
    <d:DataCollection>
      <r:URN>urn:ddi:se.researchdata:snd0015-1.DataCollection:2.0</r:URN>
      <d:CollectionEvent>
        <r:URN>urn:ddi:se.researchdata:snd0015-1.CollectionEvent:2.0</r:URN>
        <d:DataCollectionDate>
          <r:StartDate>2000-10</r:StartDate>
          <r:EndDate>2001-04</r:EndDate>
        </d:DataCollectionDate>
      </d:CollectionEvent>
    </d:DataCollection>
    <a:Archive>
      <r:URN>urn:ddi:se.researchdata:snd0015-1.Archive:2.0</r:URN>
      <a:ArchiveSpecific>
        <a:Item>
          <a:Access>
            <r:URN>urn:ddi:se.researchdata:snd0015-1.Archive-ArchiveSpecificType-AccessType:2.0</r:URN>
            <a:TypeOfAccess controlledVocabularyName="info:eu-repo-Access-Terms vocabulary">restrictedAccess</a:TypeOfAccess>
          </a:Access>
          <a:DataFileQuantity>1</a:DataFileQuantity>
        </a:Item>
      </a:ArchiveSpecific>
    </a:Archive>
  </s:StudyUnit>
</ddi:DDIInstance>