<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/NCT02966704</url>
  </required_header>
  <id_info>
    <org_study_id>NL56440.081.16</org_study_id>
    <nct_id>NCT02966704</nct_id>
  </id_info>
  <brief_title>Stable Isotope Method to Assess Dietary Protein Quality</brief_title>
  <official_title>A Dual Stable Isotope Method to Assess Dietary Protein Quality in Humans: Characterization of Intrinsically Labelled 15N Milk Protein as a Reference Protein</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The evaluation of protein quality has been identified as the top priority question by the&#xD;
      Food and Agricultural Organization (FAO) of the United Nations. However, the current&#xD;
      available methods do not precisely estimate protein quality, or need invasive procedures. The&#xD;
      proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in&#xD;
      humans.&#xD;
&#xD;
      The present project characterizes the use of 15N-intrinsically-labelled milk protein as a&#xD;
      reference-protein for development a non-invasive method that can be used to assess protein&#xD;
      quality in human subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: The evaluation of protein quality has been identified as the top priority question&#xD;
      by the Food and Agricultural Organization (FAO) of the United Nations. However, the current&#xD;
      available methods do not precisely estimate protein quality, or need invasive procedures. The&#xD;
      proposed 'dual tracer approach' is a minimal invasive method to evaluate protein quality in&#xD;
      humans.&#xD;
&#xD;
      Objective: The present project characterizes the use of 15N-intrinsically-labelled milk&#xD;
      protein as a reference-protein for development a minimal invasive method that can be used to&#xD;
      assess protein quality in human subjects. For this purpose, our primary objectives are to&#xD;
      define the digestive and metabolic behaviour and distribution of the&#xD;
      15N-intrinsically-labelled milk protein compared to the internal standard 13C-spirulina.&#xD;
&#xD;
      Study design: Randomized cross-over trial with two experimental meals. Study population:&#xD;
      Healthy male and female, age 18-35y Intervention (if applicable): On two separate test days,&#xD;
      subjects will receive a semi liquid meal (pudding) divided in 9 portions, (meal 1: 27 En%&#xD;
      Protein,10 En% fat, 62 En% carbohydrates; meal 2: 14 En% Protein,10 En% fat, 75 En%&#xD;
      carbohydrates), with intrinsically labelled 15N protein powder. Furthermore, the meal will&#xD;
      contain a trace amount of 13C-labelled algae protein as an internal standard. Meals will&#xD;
      differ in the amount (e.g. 50g or 25g) of 15N-labelled milk protein.&#xD;
&#xD;
      Main study parameters/endpoints: The ratio of isotopic enrichment (15N/13C) of (total) amino&#xD;
      acids of the test meal and the blood plasma as determined by (gas chromatography-) isotope&#xD;
      ratio mass spectrometry ((GC)-IRMS).&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: A meal challenge with intrinsically labelled protein and addition of stable&#xD;
      isotope tracer is frequently used in postprandial studies. Stable isotopes are naturally&#xD;
      occurring isotopes and are not harmful for subjects, as there is no decay. Furthermore,&#xD;
      placing venous catheters and blood sampling can occasionally cause a local haematoma or&#xD;
      bruise and some participants may report pain or discomfort. Subjects have to come to the&#xD;
      research facility three times, a screening visit of 1 hour, and 2 experimental days of 7&#xD;
      hours. Subjects will be financially compensated for participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2016</start_date>
  <completion_date type="Actual">November 21, 2016</completion_date>
  <primary_completion_date type="Actual">November 21, 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ratio of isotopic enrichment</measure>
    <time_frame>6 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Biological Availability</condition>
  <arm_group>
    <arm_group_label>meal 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mixed meal with high level of intrinsically labeled milk protein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>meal 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mixed meal with low level of intrinsically labeled milk protein</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>intrinsically labeled milk protein</intervention_name>
    <arm_group_label>meal 1</arm_group_label>
    <arm_group_label>meal 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Age: 20 - 35 y&#xD;
&#xD;
          -  BMI: 18.5 - 25 kg/m2&#xD;
&#xD;
          -  Stable dietary habits&#xD;
&#xD;
          -  Veins suitable for cannulation (blood sampling)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a history of medical or surgical events that may significantly affect the study&#xD;
             outcome&#xD;
&#xD;
          -  Medical drug use accept incidental use of paracetamol&#xD;
&#xD;
          -  (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or&#xD;
             any other endocrine disorder, active cardiovascular disease, hepatic disease, renal&#xD;
             disease, cancer&#xD;
&#xD;
          -  Milk protein intolerance&#xD;
&#xD;
          -  Alcohol consumption of &gt;14 (women) or &gt; 21 (men) units per week&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Moderate intense physical activity (exercise) for more than 5 hours/week&#xD;
&#xD;
          -  Reported weight loss or weight gain of &gt; 3 kg in the month prior to pre-study&#xD;
             screening&#xD;
&#xD;
          -  Reported slimming diet, or medically prescribed diet&#xD;
&#xD;
          -  Having a habitual diet with a protein content of &lt;10 En% &gt; 30 En%&#xD;
&#xD;
          -  Reported vegan or macrobiotic life-style&#xD;
&#xD;
          -  Recent blood donation (&lt;1 month prior to Day 01 of the study)&#xD;
&#xD;
          -  Not willing to comply to the controlled dietary intervention guidelines&#xD;
&#xD;
          -  Not willing or afraid to give up blood donation during the study&#xD;
&#xD;
          -  Personnel of Wageningen University, department of Human Nutrition, their partner and&#xD;
             their first and second degree relatives&#xD;
&#xD;
          -  Current and within 1 month participation in other research from the Division of Human&#xD;
             Nutrition&#xD;
&#xD;
          -  Not having a general practitioner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caseins</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02966704
org study id: NL56440.081.16
nct id: NCT02966704
lead sponsor: 
has dmc: No
The evaluation of protein quality has been identified as the top priority question by the
      Food and Agricultural Organization (FAO) of the United Nations. However, the current
      available methods do not precisely estimate protein quality, or need invasive procedures. The
      proposed 'dual tracer approach' is a non-invasive method to evaluate protein quality in
      humans.

      The present project characterizes the use of 15N-intrinsically-labelled milk protein as a
      reference-protein for development a non-invasive method that can be used to assess protein
      quality in human subjects
Rationale: The evaluation of protein quality has been identified as the top priority question
      by the Food and Agricultural Organization (FAO) of the United Nations. However, the current
      available methods do not precisely estimate protein quality, or need invasive procedures. The
      proposed 'dual tracer approach' is a minimal invasive method to evaluate protein quality in
      humans.

      Objective: The present project characterizes the use of 15N-intrinsically-labelled milk
      protein as a reference-protein for development a minimal invasive method that can be used to
      assess protein quality in human subjects. For this purpose, our primary objectives are to
      define the digestive and metabolic behaviour and distribution of the
      15N-intrinsically-labelled milk protein compared to the internal standard 13C-spirulina.

      Study design: Randomized cross-over trial with two experimental meals. Study population:
      Healthy male and female, age 18-35y Intervention (if applicable): On two separate test days,
      subjects will receive a semi liquid meal (pudding) divided in 9 portions, (meal 1: 27 En%
      Protein,10 En% fat, 62 En% carbohydrates; meal 2: 14 En% Protein,10 En% fat, 75 En%
      carbohydrates), with intrinsically labelled 15N protein powder. Furthermore, the meal will
      contain a trace amount of 13C-labelled algae protein as an internal standard. Meals will
      differ in the amount (e.g. 50g or 25g) of 15N-labelled milk protein.

      Main study parameters/endpoints: The ratio of isotopic enrichment (15N/13C) of (total) amino
      acids of the test meal and the blood plasma as determined by (gas chromatography-) isotope
      ratio mass spectrometry ((GC)-IRMS).

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: A meal challenge with intrinsically labelled protein and addition of stable
      isotope tracer is frequently used in postprandial studies. Stable isotopes are naturally
      occurring isotopes and are not harmful for subjects, as there is no decay. Furthermore,
      placing venous catheters and blood sampling can occasionally cause a local haematoma or
      bruise and some participants may report pain or discomfort. Subjects have to come to the
      research facility three times, a screening visit of 1 hour, and 2 experimental days of 7
      hours. Subjects will be financially compensated for participation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: ratio of isotopic enrichment
time frame: 6 hours
arm group label: meal 1
arm group type: Experimental
description: mixed meal with high level of intrinsically labeled milk protein
arm group label: meal 2
arm group type: Experimental
description: mixed meal with low level of intrinsically labeled milk protein
intervention type: Dietary Supplement
intervention name: intrinsically labeled milk protein
arm group label: meal 1
arm group label: meal 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Caseins