<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672099</url>
  </required_header>
  <id_info>
    <org_study_id>10-3-037</org_study_id>
    <nct_id>NCT01672099</nct_id>
  </id_info>
  <brief_title>Effects of Dairy on Vitamin K-status</brief_title>
  <official_title>The Effects of a Vitamin K-enriched Dairy Product on Vitamin K-status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the beneficial effect of a nutrient enriched dairy product will be&#xD;
      investigated on vitamin K-status. To achive this benefit, the study product contains extra&#xD;
      vitamin K2. In addition, extra dairy minerals have been added to the study product that may&#xD;
      support general health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In earlier studies, cardiovascular disease and osteoporosis were found to be associated with&#xD;
      K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher&#xD;
      menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal&#xD;
      absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is&#xD;
      a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a&#xD;
      nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new&#xD;
      product will be investigated on vitamin K status and on general health markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">December 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>undercarboxylated and carboxylated matrix-gla protein</measure>
    <time_frame>12 weeks</time_frame>
    <description>The purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of Matrix Gla Protein</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>undercarboxylated and carboxylated osteocalcin</measure>
    <time_frame>12 weeks</time_frame>
    <description>The second purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of the vitamin K-dependent protein osteocalcin</description>
  </secondary_outcome>
  <other_outcome>
    <measure>markers of vascular health and inflammation</measure>
    <time_frame>12 weeks</time_frame>
    <description>The secondary purpose of this study is to investigate the nutrient enriched product on markers of vascular and general health</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Vitamin K-status</condition>
  <condition>Vascular Health</condition>
  <arm_group>
    <arm_group_label>nutrient enriched dairy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Yoghurt product which contains vitamin K2 and extra dairy nutrients; all in a concentration of 15% of the recommended allowed daily intake (RDI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basic dairy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 basic yoghurt products</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>nutrient enriched product</intervention_name>
    <description>The intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.</description>
    <arm_group_label>nutrient enriched dairy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>basic dairy product</intervention_name>
    <description>The intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.</description>
    <arm_group_label>Basic dairy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy men and postmenopausal women between 45 and 65 years old&#xD;
&#xD;
          -  Subjects of body weight and height according to BMI between 23 and 30 kg/m2&#xD;
&#xD;
          -  Subjects of Caucasian race&#xD;
&#xD;
          -  Subject has given written consent to take part in the study&#xD;
&#xD;
          -  Low vitamin K-status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with hypertension&#xD;
&#xD;
          -  Subjects with hypercholesterolemia&#xD;
&#xD;
          -  Subjects with (a history of) metabolic or gastrointestinal disease&#xD;
&#xD;
          -  Subjects presenting chronic degenerative and/or inflammatory disease&#xD;
&#xD;
          -  Subjects with (a history) of diabetes mellitus&#xD;
&#xD;
          -  Abuse of drugs and/or alcohol&#xD;
&#xD;
          -  Subjects receiving corticosteroϊd treatment&#xD;
&#xD;
          -  Subjects using oral anticoagulants and subjects with clotting disorders&#xD;
&#xD;
          -  Subjects using blood pressure lowering medication&#xD;
&#xD;
          -  Subjects using cholesterol-lowering medication&#xD;
&#xD;
          -  Subjects using multivitamins or vitamin K supplements&#xD;
&#xD;
          -  Subjects consuming high amounts of vitamin K-containing food products&#xD;
&#xD;
          -  Subjects with cow's milk allergy and lactose intolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cees Vermeer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VitaK BV Maastricht University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vitak BV / Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 EV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 21, 2012</last_update_submitted>
  <last_update_submitted_qc>August 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin K2</keyword>
  <keyword>menaquinone-7</keyword>
  <keyword>vascular health</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672099
org study id: 10-3-037
nct id: NCT01672099
lead sponsor: 
has dmc: No
In this study, the beneficial effect of a nutrient enriched dairy product will be
      investigated on vitamin K-status. To achive this benefit, the study product contains extra
      vitamin K2. In addition, extra dairy minerals have been added to the study product that may
      support general health.
In earlier studies, cardiovascular disease and osteoporosis were found to be associated with
      K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher
      menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal
      absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is
      a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a
      nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new
      product will be investigated on vitamin K status and on general health markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: undercarboxylated and carboxylated matrix-gla protein
time frame: 12 weeks
description: The purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of Matrix Gla Protein
measure: undercarboxylated and carboxylated osteocalcin
time frame: 12 weeks
description: The second purpose of this study is to investigate the nutrient enriched product on vitamin K status as determined from the carboxylation status of the vitamin K-dependent protein osteocalcin
measure: markers of vascular health and inflammation
time frame: 12 weeks
description: The secondary purpose of this study is to investigate the nutrient enriched product on markers of vascular and general health
arm group label: nutrient enriched dairy
arm group type: Active Comparator
description: Yoghurt product which contains vitamin K2 and extra dairy nutrients; all in a concentration of 15% of the recommended allowed daily intake (RDI)
arm group label: Basic dairy
arm group type: Placebo Comparator
description: 2 basic yoghurt products
intervention type: Dietary Supplement
intervention name: nutrient enriched product
description: The intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
arm group label: nutrient enriched dairy
intervention type: Dietary Supplement
intervention name: basic dairy product
description: The intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
arm group label: Basic dairy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cees Vermeer, PhD
role: Principal Investigator
affiliation: VitaK BV Maastricht University
facility: 
country: Netherlands
responsible party type: Sponsor