<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/NCT03301337</url>
  </required_header>
  <id_info>
    <org_study_id>BBH 135</org_study_id>
    <nct_id>NCT03301337</nct_id>
  </id_info>
  <brief_title>Amino-acid Uptake After Meat Protein Intake</brief_title>
  <official_title>Amino-acid Uptake After Hydrolyzed Meat Protein Intake in Healthy Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DC Ingredients</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of the project is to provide evidence for the use of hydrolysed meat protein&#xD;
      (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily&#xD;
      protein intake.&#xD;
&#xD;
      The study will investigate how the meat protein derived amino acids (from either HMP, steak&#xD;
      or minced meat) are absorbed and released into the blood circulation of elderly persons.&#xD;
      Hereby, the study will explore the the anabolic potential of HMP compared with common meat&#xD;
      products.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>
    <intervention_model_description>Single-blindet randomized cross-over study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Outcome assessor and investigator will be blindet. Participants cannot be blindet, as they will consume three different meat products, that we cannot mask.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>D5-phenylalanine appearance</measure>
    <time_frame>5 hours</time_frame>
    <description>D5-phenylalanine appearance in the blood circulation after meal consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin concentration</measure>
    <time_frame>5 hours</time_frame>
    <description>Insulin concentration in the blood circulation after meal consumption</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Amino Acid Metabolism</condition>
  <arm_group>
    <arm_group_label>Hydrolyzed meat protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minced Meat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beef</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Meat protein absorption</intervention_name>
    <description>Meat protein absorption when digested together with a full meal.</description>
    <arm_group_label>Beef</arm_group_label>
    <arm_group_label>Hydrolyzed meat protein</arm_group_label>
    <arm_group_label>Minced Meat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Untrained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  below 65 years of age&#xD;
&#xD;
          -  BMI above 30&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Vegetarians&#xD;
&#xD;
          -  Subjects with diabetes or other metabolic diseases&#xD;
&#xD;
          -  Medical treatment affecting protein synthesis&#xD;
&#xD;
          -  Gastro-intestinal problems, reduced liver or kidney function, elevated blood pressure,&#xD;
             atherosclerosis&#xD;
&#xD;
          -  More than 5 ours regular physical activity per week (except physical activity related&#xD;
             to commuting)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jakob Agergaard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Sports Medicine, Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Sports Medicine Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Jakob Agergaard</investigator_full_name>
    <investigator_title>Postdoc, PhD</investigator_title>
  </responsible_party>
  <keyword>Amino acid uptake</keyword>
  <keyword>Aging</keyword>
  <keyword>Meat protein</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/NCT03301337
org study id: BBH 135
nct id: NCT03301337
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the project is to provide evidence for the use of hydrolysed meat protein
      (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily
      protein intake.

      The study will investigate how the meat protein derived amino acids (from either HMP, steak
      or minced meat) are absorbed and released into the blood circulation of elderly persons.
      Hereby, the study will explore the the anabolic potential of HMP compared with common meat
      products.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Single-blindet randomized cross-over study
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
masking description: Outcome assessor and investigator will be blindet. Participants cannot be blindet, as they will consume three different meat products, that we cannot mask.
measure: D5-phenylalanine appearance
time frame: 5 hours
description: D5-phenylalanine appearance in the blood circulation after meal consumption
measure: Insulin concentration
time frame: 5 hours
description: Insulin concentration in the blood circulation after meal consumption
arm group label: Hydrolyzed meat protein
arm group type: Experimental
description: D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.
arm group label: Minced Meat
arm group type: Experimental
description: D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.
arm group label: Beef
arm group type: Experimental
description: D5-phenylalanine intrinsically labelled hydrolyzed meat protein (0.6 g per kg lean body mass), which will be consumed together with a full meal.
intervention type: Dietary Supplement
intervention name: Meat protein absorption
description: Meat protein absorption when digested together with a full meal.
arm group label: Beef
arm group label: Hydrolyzed meat protein
arm group label: Minced Meat
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jakob Agergaard, PhD
role: Principal Investigator
affiliation: Institute of Sports Medicine, Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Jakob Agergaard
investigator title: Postdoc, PhD