xml: <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/NCT05993962</url>
    </required_header>
    <id_info>
      <org_study_id>H18-01353</org_study_id>
      <nct_id>NCT05993962</nct_id>
    </id_info>
    <brief_title>Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults</brief_title>
    <official_title>Efficacy of The Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status of Healthy Older Adults - A Double-blind, Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of British Columbia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Dairy Farmers of Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of British Columbia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Older adults are recommended to meet their daily vitamin B12 (B12) requirements by consuming&#xD;
        foods with added B12 and/or taking B12 supplements (i.e. sources of free B12) because of an&#xD;
        age-related decreased digestion and absorption capacity for food-bound B12. Currently, B12 is&#xD;
        not added to foods in Canada, except for simulated dairy and meat products. Yoghurt with&#xD;
        added B12 is a novel dairy product that could fill a gap that presently exists in the&#xD;
        Canadian market and has the potential to provide Canadian older adults with an alternative&#xD;
        dietary source of B12 that could help improve their B12 status. Thus, the objective of this&#xD;
        study was to assess the efficacy of the daily consumption of one serving of yoghurt fortified&#xD;
        with B12 versus unfortified yoghurt for 8 weeks on the B12 status of healthy older adults,&#xD;
        assessed using serum total B12. The primary hypothesis of this study was that the daily&#xD;
        consumption of B12-fortified yoghurt would increase serum total B12 concentration of older&#xD;
        adults compared to the consumption of unfortified yoghurts.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 10, 2019</start_date>
    <completion_date type="Actual">December 31, 2020</completion_date>
    <primary_completion_date type="Actual">October 31, 2019</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>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Serum total B12 concentration</measure>
      <time_frame>Change after 8 weeks of intervention</time_frame>
      <description>Direct biomarker of vitamin B12 status</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum total B12 concentration</measure>
      <time_frame>Change after 4 weeks of intervention</time_frame>
      <description>Direct biomarker of vitamin B12 status</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum holotranscobalamin (holoTC) concentration</measure>
      <time_frame>Change after 8 weeks</time_frame>
      <description>Direct biomarker of vitamin B12 status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum holotranscobalamin (holoTC) concentration</measure>
      <time_frame>Change after 4 weeks</time_frame>
      <description>Direct biomarker of vitamin B12 status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma methylmalonic acid (MMA) concentration</measure>
      <time_frame>Change after 8 weeks</time_frame>
      <description>Functional biomarker of vitamin B12 status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma methylmalonic acid (MMA) concentration</measure>
      <time_frame>Change after 4 weeks</time_frame>
      <description>Functional biomarker of vitamin B12 status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma homocysteine concentration</measure>
      <time_frame>Change after 8 weeks</time_frame>
      <description>Functional biomarker of vitamin B12 status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma homocysteine concentration</measure>
      <time_frame>Change after 4 weeks</time_frame>
      <description>Functional biomarker of vitamin B12 status</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Plasma total folate concentration</measure>
      <time_frame>Change after 8 weeks</time_frame>
      <description>Biomarker for folate status</description>
    </other_outcome>
    <other_outcome>
      <measure>Plasma total folate concentration</measure>
      <time_frame>Change after 4 weeks</time_frame>
      <description>Biomarker for folate status</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Vitamin B 12 Deficiency</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants received one daily serving (provided in one cup of 150grams) of unfortified yoghurt for 8 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fortified group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received one daily serving (provided in one cup of 150grams) of yoghurt fortified with vitamin B12 for 8 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Fortified yoghurt</intervention_name>
      <description>Food-grade vitamin B12 in the form of methylcobalamin (purity: 99%) was used for fortification. Yoghurts were Greek-style and locally produced by a yoghurt company in British Columbia, Canada. The pre-measured vitamin B12 was added into yoghurt vats in amounts that corresponded to the chosen dosage (50 µg of B12 per 150 g). The yoghurt was packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.</description>
      <arm_group_label>Fortified group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control yoghurt</intervention_name>
      <description>Yoghurts were locally produced by a yoghurt company in British Columbia, Canada. Yoghurts produced were Greek-style and packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Non-smoking and apparently healthy female and male volunteers aged&#xD;
          50-75 years, who are comfortable speaking, reading and understanding English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Chronic health conditions, especially those related to B12 metabolism and the&#xD;
               digestive tract. Chronic health conditions include diabetes, cancer, liver disease,&#xD;
               psychiatric illnesses (depression, bipolar disorder, schizophrenia, anxiety disorder,&#xD;
               eating disorder), cardiovascular disease, renal impairment, pancreatic dysfunction,&#xD;
               gastrointestinal diseases (such as, Crohn's disease, Irritable Bowel Syndrome,&#xD;
               Colitis, pernicious anemia, Celiac disease, acid indigestion, constipation,&#xD;
               diverticulitis/ diverticulosis, gastroesophageal reflux disorder, or atrophic&#xD;
               gastritis), total or partial gastrectomy, gastric bypass or other bariatric surgery,&#xD;
               ileal resection or organ reconstructive surgery.&#xD;
  &#xD;
            -  Use of prescription or over-the-counter medications that may interfere with B12&#xD;
               status, i.e., Metformin, anti-cancer treatment, antibiotics, proton pump inhibitors,&#xD;
               antacids; the use of high-dose B12 supplements for the last 1 month (e.g., 1000ug of&#xD;
               B12 per day); intramuscular B12 injections in the last 1 month; vitamin supplements&#xD;
               containing B-vitamins over the past three months; or Brewer's yeast over the past&#xD;
               three months.&#xD;
  &#xD;
            -  Individuals who are unwilling to consume one daily serving of yoghurt for 8 weeks,&#xD;
               provide blood samples and measures of height and weight, enroll and start the study in&#xD;
               early 2019, or come to the University of British Columbia (UBC) or the BC Children's&#xD;
               Hospital Research Institute (BCCHRI) site for study visits.&#xD;
  &#xD;
            -  Participants with deficient or high serum total B12 concentrations (&lt;148 and&#xD;
               &gt;400pmol/L)&#xD;
  &#xD;
            -  Individuals with allergies or sensitivities to any ingredients of yoghurt (i.e. dairy)&#xD;
  &#xD;
            -  Individuals who smoke or consume more than one drink containing alcohol each day&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yvonne Lamers, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Associate Professor, UBC Food, Nutrition and Health</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>BCCHR Clinical Research and Evaluation Unit (CREU)</name>
        <address>
          <city>Vancouver</city>
          <state>British Columbia</state>
          <zip>V5Z 4H4</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>UBC Western Nutrition Research Center (WNRC)</name>
        <address>
          <city>Vancouver</city>
          <state>British Columbia</state>
          <zip>V6T 1Z4</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>December 6, 2022</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of British Columbia</investigator_affiliation>
      <investigator_full_name>Yvonne Lamers</investigator_full_name>
      <investigator_title>Associate Professor, Food, Nutrition and Health</investigator_title>
    </responsible_party>
    <keyword>Food fortification</keyword>
    <keyword>Yogurt</keyword>
    <keyword>Vitamin B12</keyword>
    <keyword>Older adults</keyword>
    <keyword>Fortified food</keyword>
    <keyword>Yoghurt</keyword>
    <keyword>Vitamin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin B 12 Deficiency</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993962
  org study id: H18-01353
  nct id: NCT05993962
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Older adults are recommended to meet their daily vitamin B12 (B12) requirements by consuming
        foods with added B12 and/or taking B12 supplements (i.e. sources of free B12) because of an
        age-related decreased digestion and absorption capacity for food-bound B12. Currently, B12 is
        not added to foods in Canada, except for simulated dairy and meat products. Yoghurt with
        added B12 is a novel dairy product that could fill a gap that presently exists in the
        Canadian market and has the potential to provide Canadian older adults with an alternative
        dietary source of B12 that could help improve their B12 status. Thus, the objective of this
        study was to assess the efficacy of the daily consumption of one serving of yoghurt fortified
        with B12 versus unfortified yoghurt for 8 weeks on the B12 status of healthy older adults,
        assessed using serum total B12. The primary hypothesis of this study was that the daily
        consumption of B12-fortified yoghurt would increase serum total B12 concentration of older
        adults compared to the consumption of unfortified yoghurts.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: Serum total B12 concentration
  time frame: Change after 8 weeks of intervention
  description: Direct biomarker of vitamin B12 status
  measure: Serum total B12 concentration
  time frame: Change after 4 weeks of intervention
  description: Direct biomarker of vitamin B12 status
  measure: Serum holotranscobalamin (holoTC) concentration
  time frame: Change after 8 weeks
  description: Direct biomarker of vitamin B12 status
  measure: Serum holotranscobalamin (holoTC) concentration
  time frame: Change after 4 weeks
  description: Direct biomarker of vitamin B12 status
  measure: Plasma methylmalonic acid (MMA) concentration
  time frame: Change after 8 weeks
  description: Functional biomarker of vitamin B12 status
  measure: Plasma methylmalonic acid (MMA) concentration
  time frame: Change after 4 weeks
  description: Functional biomarker of vitamin B12 status
  measure: Plasma homocysteine concentration
  time frame: Change after 8 weeks
  description: Functional biomarker of vitamin B12 status
  measure: Plasma homocysteine concentration
  time frame: Change after 4 weeks
  description: Functional biomarker of vitamin B12 status
  measure: Plasma total folate concentration
  time frame: Change after 8 weeks
  description: Biomarker for folate status
  measure: Plasma total folate concentration
  time frame: Change after 4 weeks
  description: Biomarker for folate status
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Participants received one daily serving (provided in one cup of 150grams) of unfortified yoghurt for 8 weeks
  arm group label: Fortified group
  arm group type: Experimental
  description: Participants received one daily serving (provided in one cup of 150grams) of yoghurt fortified with vitamin B12 for 8 weeks
  intervention type: Dietary Supplement
  intervention name: Fortified yoghurt
  description: Food-grade vitamin B12 in the form of methylcobalamin (purity: 99%) was used for fortification. Yoghurts were Greek-style and locally produced by a yoghurt company in British Columbia, Canada. The pre-measured vitamin B12 was added into yoghurt vats in amounts that corresponded to the chosen dosage (50 µg of B12 per 150 g). The yoghurt was packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.
  arm group label: Fortified group
  intervention type: Other
  intervention name: Control yoghurt
  description: Yoghurts were locally produced by a yoghurt company in British Columbia, Canada. Yoghurts produced were Greek-style and packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yvonne Lamers, PhD
  role: Principal Investigator
  affiliation: Associate Professor, UBC Food, Nutrition and Health
  facility: 
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of British Columbia
  investigator full name: Yvonne Lamers
  investigator title: Associate Professor, Food, Nutrition and Health
  mesh term: Vitamin B 12 Deficiency