<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/NCT03749239</url>
  </required_header>
  <id_info>
    <org_study_id>Collagen_2018</org_study_id>
    <nct_id>NCT03749239</nct_id>
  </id_info>
  <brief_title>Effects of Collagen Protein on the Amino Acid Profile of the Blood</brief_title>
  <official_title>Effect of Intake of Enzymatically Hydrolyzed and Non-enzymatically Hydrolyzed Collagen Protein on the Amino Acid Profile of the Blood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      This project aims to investigate the absorption of enzymatically hydrolysed and&#xD;
      non-enzymatically hydrolysed collagen on the Amino acid profile of the blood&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2018</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amino acid profile of the blood</measure>
    <time_frame>Blood samples is collected at pre, 0 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min and 240 min.</time_frame>
    <description>AA concentrations in blood samples is determined using 1H NMR spectroscopy</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Collagen Protein</condition>
  <arm_group>
    <arm_group_label>Effects of collagen protein.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-hydrolized collagen protein</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Collagen protein</intervention_name>
    <description>Collagen protein</description>
    <arm_group_label>Effects of collagen protein.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medicine influencing protein turnover&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aarhus University, Department for Public Health, Section for Sport Science</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03749239
org study id: Collagen_2018
nct id: NCT03749239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to investigate the absorption of enzymatically hydrolysed and
      non-enzymatically hydrolysed collagen on the Amino acid profile of the blood
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Amino acid profile of the blood
time frame: Blood samples is collected at pre, 0 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min and 240 min.
description: AA concentrations in blood samples is determined using 1H NMR spectroscopy
arm group label: Effects of collagen protein.
arm group type: Experimental
description: Non-hydrolized collagen protein
intervention type: Dietary Supplement
intervention name: Collagen protein
description: Collagen protein
arm group label: Effects of collagen protein.
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Sponsor