<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/NCT03305718</url>
  </required_header>
  <id_info>
    <org_study_id>H-15020401</org_study_id>
    <nct_id>NCT03305718</nct_id>
  </id_info>
  <brief_title>Biomarkers of Meats and Potatoes Intake.</brief_title>
  <acronym>MEPO</acronym>
  <official_title>Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate&#xD;
      assessment of the intake of these foods. Twelve healthy subjects were enrolled in a&#xD;
      controlled, cross-over meal study, randomized by a Latin square design. The test meals&#xD;
      contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled&#xD;
      potatoes, chips and a control for the potato meals. A standardized diet was provided during&#xD;
      sample collection. Blood and urine samples were collected up to 48h primarily for untargeted&#xD;
      metabolomic profiling. Blood was further collected to study the effect of the meals on&#xD;
      insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum&#xD;
      lunch following the test meals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protein-rich diets improve body weight regulations and are thus believed to play a key role&#xD;
      in combating the global obesity epidemic. Protein-rich diets are generally high in meats,&#xD;
      some of which have become controverted enough to be considered disease-promoting foods&#xD;
      despite their nutritional richness. The degree at which associations with disease differs&#xD;
      from causality is however not entirely known.&#xD;
&#xD;
      Assessment of food intake currently relies on food frequency questionnaires (FFQ), 24h recall&#xD;
      and dietary records, all of which are self-reporting methods known to be subject to bias and&#xD;
      inaccuracy. Biomarkers of food intake emerged thus within the past years to complement the&#xD;
      conventional tools as objective measurements of food intake, drawn from biological samples.&#xD;
      Several biomarkers of meat consumption have been proposed, however none is currently accepted&#xD;
      and used as biomarker(s) of meat intake and none is able to differentiate between the&#xD;
      different types of meat.&#xD;
&#xD;
      In the modern diet, meats are very often served with potatoes. To our knowledge, biomarkers&#xD;
      of potato intake have not been thoroughly reported in the literature. Different cooking&#xD;
      methods were shown to potentially influence the content of bioactive constituents of&#xD;
      vegetables, their glycemic index, as well as subsequent energy intake. High heat cooking&#xD;
      additionally yields the formation of potentially toxic compounds such as advanced glycation&#xD;
      endproducts (AGEs) that were shown to contribute to insulin resistance and type 2 diabetes.&#xD;
      In this line, biomarkers of potatoes as such as well as biomarkers to differentiate between&#xD;
      different cooking methods would be of great importance in advancing the understanding of&#xD;
      nutritional science.&#xD;
&#xD;
      Primary objectives:&#xD;
&#xD;
        1. To identify acute biomarkers of general meat intake by untargeted metabolomics&#xD;
&#xD;
        2. To explore the changes in the metabolome as a result of acute exposure to three types of&#xD;
           meat and identify meat-specific biomarkers of intake&#xD;
&#xD;
        3. To identify biomarkers of acute potato intake by untargeted metabolomics&#xD;
&#xD;
        4. To identify biomarkers that can differentiate between three types of cooking methods&#xD;
&#xD;
        5. To investigate the effect of the interaction between meat on potatoes on satiety,&#xD;
           assessed by registration of intake from an ad libitum meal&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. To validate already known biomarkers of meat intake by targeted metabolomics&#xD;
&#xD;
        2. To investigate the effect of the interaction between meat and potatoes on satiety,&#xD;
           assessed by visual analogue scales&#xD;
&#xD;
        3. To investigate the effect of the interaction between meat and potatoes on glucose and&#xD;
           insulin responses&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2015</start_date>
  <completion_date type="Actual">May 30, 2015</completion_date>
  <primary_completion_date type="Actual">May 30, 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary meat metabolites (metabolic profiling with mass spectrometry)</measure>
    <time_frame>Hours 0-48</time_frame>
    <description>Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma meat metabolites (metabolic profiling with mass spectrometry)</measure>
    <time_frame>Hours 0-48</time_frame>
    <description>Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary potato metabolites (metabolic profiling with mass spectrometry)</measure>
    <time_frame>Hours 0-48</time_frame>
    <description>Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma potato metabolites (metabolic profiling with mass spectrometry)</measure>
    <time_frame>Hours 0-48</time_frame>
    <description>Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective assessment of satiety</measure>
    <time_frame>Hours 0-7</time_frame>
    <description>Measured by the weight of an ad libitum meal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urine biomarkers of meat intake</measure>
    <time_frame>Hours 0-48</time_frame>
    <description>Targeted approach with mass spectrometry on already proposed meat biomarkers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective assessment of satiety</measure>
    <time_frame>Hours 0-6</time_frame>
    <description>Assessed by visual analogue scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve for glucose</measure>
    <time_frame>Minutes 0-180</time_frame>
    <description>Glucose is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve for insulin</measure>
    <time_frame>Minutes 0-180</time_frame>
    <description>Insulin is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Biomarkers of Food Intake in Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Meal sequence: 3C1A2B4D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 3C1A2B4D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 2A3D4C1B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 2A3D4C1B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 2D4B3A1C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 2D4B3A1C.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 3B2C1D4A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 3B2C1D4A.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 4C2B1A3D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 4C2B1A3D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence:1B4D3C2A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 1B4D3C2A.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence:4A1C2D3B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 4A1C2D3B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence:1D3A4B2C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 1D3A4B2C.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 4D3B2C1A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 4D3B2C1A.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 3A4C1B2D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 3A4C1B2D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 1C2A3D4B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 1C2A3D4B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal sequence: 2B1D4A3C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.&#xD;
Each participants randomized to this arm is exposed to 4 test meals in the order 2B1D4A3C.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 3C1A2B4D</intervention_name>
    <description>Participants receive test meals in the sequence 3C1A2B4D</description>
    <arm_group_label>Meal sequence: 3C1A2B4D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 2A3D4C1B</intervention_name>
    <description>Participants receive test meals in the sequence 2A3D4C1B</description>
    <arm_group_label>Meal sequence: 2A3D4C1B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 2D4B3A1C</intervention_name>
    <description>Participants receive test meals in the sequence 2D4B3A1C</description>
    <arm_group_label>Meal sequence: 2D4B3A1C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 3B2C1D4A</intervention_name>
    <description>Participants receive test meals in the sequence 3B2C1D4A</description>
    <arm_group_label>Meal sequence: 3B2C1D4A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 4C2B1A3D</intervention_name>
    <description>Participants receive test meals in the sequence 4C2B1A3D</description>
    <arm_group_label>Meal sequence: 4C2B1A3D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence:1B4D3C2A</intervention_name>
    <description>Participants receive test meals in the sequence 1B4D3C2A</description>
    <arm_group_label>Meal sequence:1B4D3C2A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence:4A1C2D3B</intervention_name>
    <description>Participants receive test meals in the sequence 4A1C2D3B</description>
    <arm_group_label>Meal sequence:4A1C2D3B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence:1D3A4B2C</intervention_name>
    <description>Participants receive test meals in the sequence 1D3A4B2C</description>
    <arm_group_label>Meal sequence:1D3A4B2C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 4D3B2C1A</intervention_name>
    <description>Participants receive test meals in the sequence 4D3B2C1A</description>
    <arm_group_label>Meal sequence: 4D3B2C1A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 3A4C1B2D</intervention_name>
    <description>Participants receive test meals in the sequence 3A4C1B2D</description>
    <arm_group_label>Meal sequence: 3A4C1B2D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 1C2A3D4B</intervention_name>
    <description>Participants receive test meals in the sequence 1C2A3D4B</description>
    <arm_group_label>Meal sequence: 1C2A3D4B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal sequence: 2B1D4A3C</intervention_name>
    <description>Participants receive test meals in the sequence 2B1D4A3C</description>
    <arm_group_label>Meal sequence: 2B1D4A3C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &lt; 30 kg/m2&#xD;
&#xD;
          -  Eating and tolerating meat, egg, pea, rice, and potatoes&#xD;
&#xD;
          -  No current chronic or infectious disease&#xD;
&#xD;
          -  No medication (oral contraceptive pill and mild antidepressants is allowed)&#xD;
&#xD;
          -  No dietary supplements&#xD;
&#xD;
          -  Did not use antibiotics in the 6 previous months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that makes the project responsible researcher to doubt the feasibility&#xD;
             of the volunteer's participation&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Smoking (12 months of non-smoking is allowed)&#xD;
&#xD;
          -  Vegan or vegetarian&#xD;
&#xD;
          -  Have or have had a drug addiction&#xD;
&#xD;
          -  Blood donations within three months before participating in the current trial or&#xD;
             participation in other scientific experiments&#xD;
&#xD;
          -  Alcohol consumption higher than the Danish Health Authority recommendation of 7 or 14&#xD;
             drinks/week for women and men, respectively.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Professor Lars Ove Dragsted</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03305718
org study id: H-15020401
nct id: NCT03305718
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate
      assessment of the intake of these foods. Twelve healthy subjects were enrolled in a
      controlled, cross-over meal study, randomized by a Latin square design. The test meals
      contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled
      potatoes, chips and a control for the potato meals. A standardized diet was provided during
      sample collection. Blood and urine samples were collected up to 48h primarily for untargeted
      metabolomic profiling. Blood was further collected to study the effect of the meals on
      insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum
      lunch following the test meals.
Protein-rich diets improve body weight regulations and are thus believed to play a key role
      in combating the global obesity epidemic. Protein-rich diets are generally high in meats,
      some of which have become controverted enough to be considered disease-promoting foods
      despite their nutritional richness. The degree at which associations with disease differs
      from causality is however not entirely known.

      Assessment of food intake currently relies on food frequency questionnaires (FFQ), 24h recall
      and dietary records, all of which are self-reporting methods known to be subject to bias and
      inaccuracy. Biomarkers of food intake emerged thus within the past years to complement the
      conventional tools as objective measurements of food intake, drawn from biological samples.
      Several biomarkers of meat consumption have been proposed, however none is currently accepted
      and used as biomarker(s) of meat intake and none is able to differentiate between the
      different types of meat.

      In the modern diet, meats are very often served with potatoes. To our knowledge, biomarkers
      of potato intake have not been thoroughly reported in the literature. Different cooking
      methods were shown to potentially influence the content of bioactive constituents of
      vegetables, their glycemic index, as well as subsequent energy intake. High heat cooking
      additionally yields the formation of potentially toxic compounds such as advanced glycation
      endproducts (AGEs) that were shown to contribute to insulin resistance and type 2 diabetes.
      In this line, biomarkers of potatoes as such as well as biomarkers to differentiate between
      different cooking methods would be of great importance in advancing the understanding of
      nutritional science.

      Primary objectives:

        1. To identify acute biomarkers of general meat intake by untargeted metabolomics

        2. To explore the changes in the metabolome as a result of acute exposure to three types of
           meat and identify meat-specific biomarkers of intake

        3. To identify biomarkers of acute potato intake by untargeted metabolomics

        4. To identify biomarkers that can differentiate between three types of cooking methods

        5. To investigate the effect of the interaction between meat on potatoes on satiety,
           assessed by registration of intake from an ad libitum meal

      Secondary objectives:

        1. To validate already known biomarkers of meat intake by targeted metabolomics

        2. To investigate the effect of the interaction between meat and potatoes on satiety,
           assessed by visual analogue scales

        3. To investigate the effect of the interaction between meat and potatoes on glucose and
           insulin responses
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Urinary meat metabolites (metabolic profiling with mass spectrometry)
time frame: Hours 0-48
description: Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat
measure: Plasma meat metabolites (metabolic profiling with mass spectrometry)
time frame: Hours 0-48
description: Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat
measure: Urinary potato metabolites (metabolic profiling with mass spectrometry)
time frame: Hours 0-48
description: Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods
measure: Plasma potato metabolites (metabolic profiling with mass spectrometry)
time frame: Hours 0-48
description: Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods
measure: Objective assessment of satiety
time frame: Hours 0-7
description: Measured by the weight of an ad libitum meal
measure: Urine biomarkers of meat intake
time frame: Hours 0-48
description: Targeted approach with mass spectrometry on already proposed meat biomarkers
measure: Subjective assessment of satiety
time frame: Hours 0-6
description: Assessed by visual analogue scale (VAS)
measure: Area under the curve for glucose
time frame: Minutes 0-180
description: Glucose is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
measure: Area under the curve for insulin
time frame: Minutes 0-180
description: Insulin is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
arm group label: Meal sequence: 3C1A2B4D
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 3C1A2B4D.
arm group label: Meal sequence: 2A3D4C1B
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 2A3D4C1B.
arm group label: Meal sequence: 2D4B3A1C
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 2D4B3A1C.
arm group label: Meal sequence: 3B2C1D4A
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 3B2C1D4A.
arm group label: Meal sequence: 4C2B1A3D
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 4C2B1A3D.
arm group label: Meal sequence:1B4D3C2A
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 1B4D3C2A.
arm group label: Meal sequence:4A1C2D3B
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 4A1C2D3B.
arm group label: Meal sequence:1D3A4B2C
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 1D3A4B2C.
arm group label: Meal sequence: 4D3B2C1A
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 4D3B2C1A.
arm group label: Meal sequence: 3A4C1B2D
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 3A4C1B2D.
arm group label: Meal sequence: 1C2A3D4B
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 1C2A3D4B.
arm group label: Meal sequence: 2B1D4A3C
arm group type: Experimental
description: In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 2B1D4A3C.
intervention type: Other
intervention name: Meal sequence: 3C1A2B4D
description: Participants receive test meals in the sequence 3C1A2B4D
arm group label: Meal sequence: 3C1A2B4D
intervention type: Other
intervention name: Meal sequence: 2A3D4C1B
description: Participants receive test meals in the sequence 2A3D4C1B
arm group label: Meal sequence: 2A3D4C1B
intervention type: Other
intervention name: Meal sequence: 2D4B3A1C
description: Participants receive test meals in the sequence 2D4B3A1C
arm group label: Meal sequence: 2D4B3A1C
intervention type: Other
intervention name: Meal sequence: 3B2C1D4A
description: Participants receive test meals in the sequence 3B2C1D4A
arm group label: Meal sequence: 3B2C1D4A
intervention type: Other
intervention name: Meal sequence: 4C2B1A3D
description: Participants receive test meals in the sequence 4C2B1A3D
arm group label: Meal sequence: 4C2B1A3D
intervention type: Other
intervention name: Meal sequence:1B4D3C2A
description: Participants receive test meals in the sequence 1B4D3C2A
arm group label: Meal sequence:1B4D3C2A
intervention type: Other
intervention name: Meal sequence:4A1C2D3B
description: Participants receive test meals in the sequence 4A1C2D3B
arm group label: Meal sequence:4A1C2D3B
intervention type: Other
intervention name: Meal sequence:1D3A4B2C
description: Participants receive test meals in the sequence 1D3A4B2C
arm group label: Meal sequence:1D3A4B2C
intervention type: Other
intervention name: Meal sequence: 4D3B2C1A
description: Participants receive test meals in the sequence 4D3B2C1A
arm group label: Meal sequence: 4D3B2C1A
intervention type: Other
intervention name: Meal sequence: 3A4C1B2D
description: Participants receive test meals in the sequence 3A4C1B2D
arm group label: Meal sequence: 3A4C1B2D
intervention type: Other
intervention name: Meal sequence: 1C2A3D4B
description: Participants receive test meals in the sequence 1C2A3D4B
arm group label: Meal sequence: 1C2A3D4B
intervention type: Other
intervention name: Meal sequence: 2B1D4A3C
description: Participants receive test meals in the sequence 2B1D4A3C
arm group label: Meal sequence: 2B1D4A3C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Professor Lars Ove Dragsted
investigator title: Professor