<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/NCT03303729</url>
  </required_header>
  <id_info>
    <org_study_id>H-17017363</org_study_id>
    <nct_id>NCT03303729</nct_id>
  </id_info>
  <brief_title>Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein (ICADP)</brief_title>
  <acronym>ICADP</acronym>
  <official_title>Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Birmingham</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>
      10 young males will be recruited to participate in a randomized double blinded crossover&#xD;
      study to investigate the influence of concomitant intake of two different types of&#xD;
      carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino&#xD;
      acids and the impact on myofibrillar protein synthesis. During the trial days the subjects&#xD;
      will perform a bout of whole body resistance exercise and ingest a supplement of meat&#xD;
      hydrolysate labeled with D5-phenylalanine together with randomized and double blinded type of&#xD;
      carbohydrate consisting of either glucose or cluster dextrin.&#xD;
&#xD;
      The primary outcome is the time to obtain peak concentration of D5-phenylalanine after intake&#xD;
      of meat hydrolysate with either glucose or cluster dextrin.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
      I) The cluster dextrin will increase the absorption of the amino acids from the meat&#xD;
      hydrolysate, and thereby result in a faster rise and a higher peak in plasma amino acid&#xD;
      concentration in the postprandial period.&#xD;
&#xD;
      II) The meat hydrolysate will increase the protein synthesis rate to a higher extent when&#xD;
      combined with cluster dextrin than with glucose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Actual">February 23, 2018</completion_date>
  <primary_completion_date type="Actual">February 23, 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Protein hydrolysate amino acid label time to peak appearance in plasma</measure>
    <time_frame>From hour 0 to hour 3</time_frame>
    <description>Difference between the time to peak of protein-derived D5-phenylalanine amino acid appearance in the plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myofibrillar protein fractional synthesis rate response to protein and carbohydrate intake after a whole body resistance exercise</measure>
    <time_frame>from hour 0,5 to hour hour 1. From hour 1 to hour 3. From hour 0,5 to hour 3.</time_frame>
    <description>Difference between myofibrillar protein fractional synthesis rate after meat hydrolysate with either 75 grams of Cluster Dextrin or Clucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein hydrolysate amino acid label area under the concentration curve in plasma</measure>
    <time_frame>From hour 0 to hour 3</time_frame>
    <description>Difference between the area under the concentration curve of protein-derived D5-phenylalanine amino acid appearance in the plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin concentration</measure>
    <time_frame>From hour 0 to hour 3</time_frame>
    <description>Difference between insulin concentrations after intake of the two carbohydrate types.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Muscle Protein Synthesis</condition>
  <condition>Amino Acid</condition>
  <arm_group>
    <arm_group_label>Meat hydrolysate &amp; Cluster Dextrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meat hydrolysate containing 25g of protein given together with 75 grams of Cluster Dextrin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meat hydrolysate &amp; placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Meat hydrolysate containing 25g of protein given together with 75 grams of Glucose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Meat Hydrolysate</intervention_name>
    <description>25 grams of meat hydrolysate to maximally stimulate protein synthesis.</description>
    <arm_group_label>Meat hydrolysate &amp; Cluster Dextrin</arm_group_label>
    <arm_group_label>Meat hydrolysate &amp; placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cluster Dextrin</intervention_name>
    <description>75 grams of Cluster Dextrin</description>
    <arm_group_label>Meat hydrolysate &amp; Cluster Dextrin</arm_group_label>
    <other_name>CAS no.: 9050-36-6</other_name>
    <other_name>Glico Nutrition Co., Ltd.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>75 grams of Glucose</description>
    <arm_group_label>Meat hydrolysate &amp; placebo</arm_group_label>
    <other_name>Glucose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  young healthy adults,&#xD;
&#xD;
          -  organised sport/training 1-3 times per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject younger than 18 years or above 30 years&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  Chronic medical diseases: active cancer, renal diseases, metabolic diseases like&#xD;
             diabetes mellitus.&#xD;
&#xD;
          -  Physical inactivity. Subjects must participate in systematized weekly exercise 1-3&#xD;
             times per week.&#xD;
&#xD;
          -  Participating in systematized exercise more than 3 times per week.&#xD;
&#xD;
          -  Vegetarian.&#xD;
&#xD;
          -  Participating in a special diet which deviates from the standard of young adults.&#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>
  <overall_official>
    <last_name>Jacob L. Bülow, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bispebjerg Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lars Holm, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Birmingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Kjaer, MD, prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bispebjerg Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sofus Sølyst, stud.med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikkel Jensen, Stud.scient.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen NV</state>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Lars Holm</investigator_full_name>
    <investigator_title>PhD, MSc</investigator_title>
  </responsible_party>
  <keyword>Carbohydrate</keyword>
  <keyword>Cluster Dextrin</keyword>
  <keyword>Exercise training</keyword>
  <keyword>Protein supplement</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/NCT03303729
org study id: H-17017363
nct id: NCT03303729
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
10 young males will be recruited to participate in a randomized double blinded crossover
      study to investigate the influence of concomitant intake of two different types of
      carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino
      acids and the impact on myofibrillar protein synthesis. During the trial days the subjects
      will perform a bout of whole body resistance exercise and ingest a supplement of meat
      hydrolysate labeled with D5-phenylalanine together with randomized and double blinded type of
      carbohydrate consisting of either glucose or cluster dextrin.

      The primary outcome is the time to obtain peak concentration of D5-phenylalanine after intake
      of meat hydrolysate with either glucose or cluster dextrin.

      Hypotheses:

      I) The cluster dextrin will increase the absorption of the amino acids from the meat
      hydrolysate, and thereby result in a faster rise and a higher peak in plasma amino acid
      concentration in the postprandial period.

      II) The meat hydrolysate will increase the protein synthesis rate to a higher extent when
      combined with cluster dextrin than with glucose.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Protein hydrolysate amino acid label time to peak appearance in plasma
time frame: From hour 0 to hour 3
description: Difference between the time to peak of protein-derived D5-phenylalanine amino acid appearance in the plasma
measure: Myofibrillar protein fractional synthesis rate response to protein and carbohydrate intake after a whole body resistance exercise
time frame: from hour 0,5 to hour hour 1. From hour 1 to hour 3. From hour 0,5 to hour 3.
description: Difference between myofibrillar protein fractional synthesis rate after meat hydrolysate with either 75 grams of Cluster Dextrin or Clucose.
measure: Protein hydrolysate amino acid label area under the concentration curve in plasma
time frame: From hour 0 to hour 3
description: Difference between the area under the concentration curve of protein-derived D5-phenylalanine amino acid appearance in the plasma
measure: Insulin concentration
time frame: From hour 0 to hour 3
description: Difference between insulin concentrations after intake of the two carbohydrate types.
arm group label: Meat hydrolysate & Cluster Dextrin
arm group type: Experimental
description: Meat hydrolysate containing 25g of protein given together with 75 grams of Cluster Dextrin.
arm group label: Meat hydrolysate & placebo
arm group type: Active Comparator
description: Meat hydrolysate containing 25g of protein given together with 75 grams of Glucose.
intervention type: Dietary Supplement
intervention name: Meat Hydrolysate
description: 25 grams of meat hydrolysate to maximally stimulate protein synthesis.
arm group label: Meat hydrolysate & Cluster Dextrin
arm group label: Meat hydrolysate & placebo
intervention type: Dietary Supplement
intervention name: Cluster Dextrin
description: 75 grams of Cluster Dextrin
arm group label: Meat hydrolysate & Cluster Dextrin
other name: CAS no.: 9050-36-6
other name: Glico Nutrition Co., Ltd.
intervention type: Dietary Supplement
intervention name: Placebo
description: 75 grams of Glucose
arm group label: Meat hydrolysate & placebo
other name: Glucose
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacob L. Bülow, MD
role: Principal Investigator
affiliation: Bispebjerg Hospital
last name: Lars Holm, Prof.
role: Principal Investigator
affiliation: University of Birmingham
last name: Michael Kjaer, MD, prof.
role: Principal Investigator
affiliation: Bispebjerg Hospital
last name: Sofus Sølyst, stud.med.
role: Principal Investigator
affiliation: University of Copenhagen
last name: Mikkel Jensen, Stud.scient.
role: Principal Investigator
affiliation: University of Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Lars Holm
investigator title: PhD, MSc