<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/NCT01734473</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0561</org_study_id>
    <nct_id>NCT01734473</nct_id>
  </id_info>
  <brief_title>Casein Protein and Leucine Supplementation in Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>Casein Protein and Leucine Supplementation to Induce Anabolism in COPD Patients and Healthy Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas A&amp;M University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weight loss commonly occurs in patients with COPD, negatively influencing their quality of&#xD;
      life, treatment response and survival. Loss of muscle protein is generally a central&#xD;
      component of this weight loss and independently increases mortality. This study will provide&#xD;
      relevant clinical information in regards to the anabolic properties of specific dietary&#xD;
      substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a&#xD;
      hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than&#xD;
      a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy&#xD;
      older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only&#xD;
      enhances the protein anabolic response in COPD patients and healthy older adults when&#xD;
      carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient&#xD;
      protein anabolic response to a hydrolyzed casein-based protein meal than healthy older&#xD;
      adults.&#xD;
&#xD;
      A fifth study day was added to measure protein requirements of included individuals to be&#xD;
      able to interpret their response to the other interventions on the other study days, and to&#xD;
      test the hypothesis that subjects with lower protein requirements respond less to&#xD;
      intervention with leucine and/or carbohydrates. For the 5th additional test day we will first&#xD;
      approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days&#xD;
      (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen&#xD;
      these subjects by phone for eligibility and check for changes in their recent medical history&#xD;
      (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still&#xD;
      met, these subjects will be asked to provide a written re-consent. If necessary, we will&#xD;
      recruit new subjects who will complete only one of the four test days (i.e. the test day on&#xD;
      which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the&#xD;
      additional 5th study day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study involves 5 study days. The duration of the first 4 study days is approximately 6.5&#xD;
      hours per day and the duration of the 5th study day is approximately 8 hours. On each of the&#xD;
      first 4 study days the effect a casein protein meal with or without leucine and carbohydrates&#xD;
      will be examined. On the fifth study day the effect of 4 different levels of casein protein&#xD;
      and carbohydrate intake by sip feeding (every 20 minutes) is examined.&#xD;
&#xD;
      Also, subjects will receive a mixture of amino acids (little parts of protein) which are a&#xD;
      little bit heavier than normal, called stable isotopes. This is the so-called stable isotope&#xD;
      method to investigate protein behavior in the body (protein kinetics). Altogether about 75 ml&#xD;
      of blood will be drawn per study day to assess outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Net whole-body protein synthesis</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal</time_frame>
    <description>Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Net whole-body protein synthesis with different levels of protein intake (Fifth Study Day)</measure>
    <time_frame>before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)</time_frame>
    <description>Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown) with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole-body protein synthesis</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal</time_frame>
    <description>Change in whole-body protein synthesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-body protein breakdown</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal</time_frame>
    <description>Change in whole-body protein breakdown</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Splanchnic extraction</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal</time_frame>
    <description>The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>1 day</time_frame>
    <description>Difference in muscle mass, fat mass and bone density between COPD patients and healthy older adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal and respiratory muscle strength</measure>
    <time_frame>1 day</time_frame>
    <description>Difference in handgrip strength and fatigue and maximum inspiratory and expiratory pressure between COPD patients and healthy older adults</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory mediators</measure>
    <time_frame>90 min before protein meal</time_frame>
    <description>C-reactive protein, interleukines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hormones</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of insulin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal</time_frame>
    <description>Peak plasma concentration (Cmax) of glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amino acid concentrations</measure>
    <time_frame>0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal</time_frame>
    <description>Peak plasma concentration (Cmax) of amino acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-body protein synthesis with different levels of protein intake (Fifth Study Day)</measure>
    <time_frame>before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)</time_frame>
    <description>Change in whole-body protein synthesis with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-body protein breakdown with different levels of protein intake (Fifth Study Day)</measure>
    <time_frame>before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)</time_frame>
    <description>Change in whole-body protein breakdown with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Splanchnic extraction with different levels of protein intake (Fifth Study Day)</measure>
    <time_frame>before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)</time_frame>
    <description>The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake of 4 different levels of protein (duration of each level: 2 hours) as sip feeding (every 20 minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hormones with different levels of protein intake (Fifth Study Day)</measure>
    <time_frame>before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of insulin with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose with different levels of protein intake (Fifth Study Day)</measure>
    <time_frame>before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)</time_frame>
    <description>Peak plasma concentration (Cmax) of glucose with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amino acid concentrations with different levels of protein intake (Fifth Study Day)</measure>
    <time_frame>before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)</time_frame>
    <description>Peak plasma concentration (Cmax) of amino acids with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Occurrence of (serious) adverse events</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Number of (serious) adverse events</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Study day 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrolyzed casein protein. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study day 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrolyzed casein protein + carbohydrates. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study day 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrolyzed casein protein + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study day 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrolyzed casein protein + carbohydrates + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Day 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 levels of hydrolyzed casein protein + carbohydrates</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrolyzed casein protein</intervention_name>
    <description>Amount provided is based on the fat-free mass of subject</description>
    <arm_group_label>Study day 1</arm_group_label>
    <other_name>PeptoPro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrolyzed casein protein + carbohydrates</intervention_name>
    <description>Amount provided is based on the fat-free mass of subject</description>
    <arm_group_label>Study day 2</arm_group_label>
    <other_name>PeptoPro + maltodextrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrolyzed casein protein + leucine</intervention_name>
    <description>Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)</description>
    <arm_group_label>Study day 3</arm_group_label>
    <other_name>PeptoPro + leucine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrolyzed casein protein + carbohydrates + leucine</intervention_name>
    <description>Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)</description>
    <arm_group_label>Study day 4</arm_group_label>
    <other_name>PeptoPro + maltodextrin + leucine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>4 levels of hydrolyzed casein protein + carbohydrates</intervention_name>
    <description>Amount provided is based on the fat-free mass of subject. The 4 levels are: 0, 0.02, 0.05, 0.15 g casein protein/kg fat free mass/hr. The ratio between protein and carbohydrates is fixed.</description>
    <arm_group_label>Study Day 5</arm_group_label>
    <other_name>4 levels of PeptoPro + maltodextrin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria COPD subjects:&#xD;
&#xD;
          -  Ability to walk, sit down and stand up independently&#xD;
&#xD;
          -  Age 45 years or older&#xD;
&#xD;
          -  Ability to lie in supine or elevated position for 5.5 hours&#xD;
&#xD;
          -  Diagnosis of moderate to very severe chronic airflow limitation and compliant to the&#xD;
             following criteria: Forced Expiratory Volume(FEV1)/Forced Vital Capacity (FVC) &lt; 0.70&#xD;
             and FEV1 &lt; 70% of reference FEV1&#xD;
&#xD;
          -  Clinically stable condition and not suffering from a respiratory tract infection or&#xD;
             exacerbation of their disease (defined as a combination of increased cough, sputum&#xD;
             purulence, shortness of breath, systemic symptoms such as fever, and a decrease in&#xD;
             FEV1 &gt; 10% compared with values when clinically stable in the preceding year) at least&#xD;
             4 weeks prior to the first test day&#xD;
&#xD;
          -  Shortness of breath on exertion&#xD;
&#xD;
          -  Willingness and ability to comply with the protocol, including:&#xD;
&#xD;
               -  Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study&#xD;
                  visit&#xD;
&#xD;
        Inclusion criteria healthy control subjects:&#xD;
&#xD;
          -  Healthy male or female according to the investigator's or appointed staff's judgment&#xD;
&#xD;
          -  Ability to walk, sit down and stand up independently&#xD;
&#xD;
          -  Age 45 years or older&#xD;
&#xD;
          -  Ability to lay in supine or elevated position for 5.5 hours&#xD;
&#xD;
          -  No diagnosis of chronic airflow limitation and compliant to the following criteria:&#xD;
             FEV1/FVC &gt; 0.70 and FEV1 ≥ 80% of reference FEV1&#xD;
&#xD;
          -  Willingness and ability to comply with the protocol, including:&#xD;
&#xD;
               -  Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study&#xD;
                  visit&#xD;
&#xD;
        Exclusion Criteria all subjects:&#xD;
&#xD;
          -  Any condition that may interfere with the definition 'healthy subject' according to&#xD;
             the investigator's judgment (for healthy control group only)&#xD;
&#xD;
          -  Established diagnosis of malignancy&#xD;
&#xD;
          -  Established diagnosis of Insulin Dependent Diabetes Mellitus&#xD;
&#xD;
          -  History of untreated metabolic diseases including hepatic or renal disorder&#xD;
&#xD;
          -  Presence of acute illness or metabolically unstable chronic illness&#xD;
&#xD;
          -  Recent myocardial infarction (less than 1 year)&#xD;
&#xD;
          -  Any other condition according to the PI or nurse that was found during the screening&#xD;
             visit, that would interfere with the study or safety of the patient&#xD;
&#xD;
          -  BMI of &lt; 18.5 or ≥ 35 kg/m2&#xD;
&#xD;
          -  Dietary or lifestyle characteristics:&#xD;
&#xD;
               -  Use of protein or amino acid containing nutritional supplements within 5 days of&#xD;
                  first test day&#xD;
&#xD;
               -  Current alcohol or drug abuse&#xD;
&#xD;
          -  Indications related to interaction with study products:&#xD;
&#xD;
               -  Known allergy to milk or milk products&#xD;
&#xD;
          -  Use of long-term oral corticosteroids or short course of oral corticosteroids 4 weeks&#xD;
             preceding first test day&#xD;
&#xD;
          -  Failure to give informed consent or Investigator's uncertainty about the willingness&#xD;
             or ability of the subject to comply with the protocol requirements&#xD;
&#xD;
          -  (Possible) pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marielle PK Engelen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas A&amp;M University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas A&amp;M University</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77843</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.dsm.com/markets/foodandbeverages/en_US/products/nutraceuticals/peptopro.html</url>
    <description>PeptoPro</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas A&amp;M University</investigator_affiliation>
    <investigator_full_name>Marielle PKJ Engelen, PhD</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Protein synthesis</keyword>
  <keyword>Protein breakdown</keyword>
  <keyword>Muscle wasting</keyword>
  <keyword>Leucine</keyword>
  <keyword>Hydrolyzed</keyword>
  <keyword>Casein protein</keyword>
  <keyword>Carbohydrates</keyword>
  <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/NCT01734473
org study id: 2012-0561
nct id: NCT01734473
lead sponsor: 
has dmc: No
Weight loss commonly occurs in patients with COPD, negatively influencing their quality of
      life, treatment response and survival. Loss of muscle protein is generally a central
      component of this weight loss and independently increases mortality. This study will provide
      relevant clinical information in regards to the anabolic properties of specific dietary
      substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a
      hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than
      a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy
      older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only
      enhances the protein anabolic response in COPD patients and healthy older adults when
      carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient
      protein anabolic response to a hydrolyzed casein-based protein meal than healthy older
      adults.

      A fifth study day was added to measure protein requirements of included individuals to be
      able to interpret their response to the other interventions on the other study days, and to
      test the hypothesis that subjects with lower protein requirements respond less to
      intervention with leucine and/or carbohydrates. For the 5th additional test day we will first
      approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days
      (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen
      these subjects by phone for eligibility and check for changes in their recent medical history
      (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still
      met, these subjects will be asked to provide a written re-consent. If necessary, we will
      recruit new subjects who will complete only one of the four test days (i.e. the test day on
      which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the
      additional 5th study day.
The study involves 5 study days. The duration of the first 4 study days is approximately 6.5
      hours per day and the duration of the 5th study day is approximately 8 hours. On each of the
      first 4 study days the effect a casein protein meal with or without leucine and carbohydrates
      will be examined. On the fifth study day the effect of 4 different levels of casein protein
      and carbohydrate intake by sip feeding (every 20 minutes) is examined.

      Also, subjects will receive a mixture of amino acids (little parts of protein) which are a
      little bit heavier than normal, called stable isotopes. This is the so-called stable isotope
      method to investigate protein behavior in the body (protein kinetics). Altogether about 75 ml
      of blood will be drawn per study day to assess outcome measures.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Net whole-body protein synthesis
time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
description: Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown)
measure: Net whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
description: Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown) with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
measure: Whole-body protein synthesis
time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
description: Change in whole-body protein synthesis
measure: Whole-body protein breakdown
time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
description: Change in whole-body protein breakdown
measure: Splanchnic extraction
time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
description: The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake
measure: Body composition
time frame: 1 day
description: Difference in muscle mass, fat mass and bone density between COPD patients and healthy older adults
measure: Skeletal and respiratory muscle strength
time frame: 1 day
description: Difference in handgrip strength and fatigue and maximum inspiratory and expiratory pressure between COPD patients and healthy older adults
measure: Inflammatory mediators
time frame: 90 min before protein meal
description: C-reactive protein, interleukines
measure: Hormones
time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
description: Area under the plasma concentration versus time curve (AUC) of insulin
measure: Glucose
time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
description: Peak plasma concentration (Cmax) of glucose
measure: Amino acid concentrations
time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
description: Peak plasma concentration (Cmax) of amino acids
measure: Whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
description: Change in whole-body protein synthesis with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
measure: Whole-body protein breakdown with different levels of protein intake (Fifth Study Day)
time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
description: Change in whole-body protein breakdown with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
measure: Splanchnic extraction with different levels of protein intake (Fifth Study Day)
time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
description: The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake of 4 different levels of protein (duration of each level: 2 hours) as sip feeding (every 20 minutes)
measure: Hormones with different levels of protein intake (Fifth Study Day)
time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
description: Area under the plasma concentration versus time curve (AUC) of insulin with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
measure: Glucose with different levels of protein intake (Fifth Study Day)
time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
description: Peak plasma concentration (Cmax) of glucose with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
measure: Amino acid concentrations with different levels of protein intake (Fifth Study Day)
time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
description: Peak plasma concentration (Cmax) of amino acids with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
measure: Occurrence of (serious) adverse events
time frame: Up to 1 year
description: Number of (serious) adverse events
arm group label: Study day 1
arm group type: Experimental
description: Hydrolyzed casein protein. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.
arm group label: Study day 2
arm group type: Experimental
description: Hydrolyzed casein protein + carbohydrates. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.
arm group label: Study day 3
arm group type: Experimental
description: Hydrolyzed casein protein + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.
arm group label: Study day 4
arm group type: Experimental
description: Hydrolyzed casein protein + carbohydrates + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.
arm group label: Study Day 5
arm group type: Experimental
description: 4 levels of hydrolyzed casein protein + carbohydrates
intervention type: Dietary Supplement
intervention name: Hydrolyzed casein protein
description: Amount provided is based on the fat-free mass of subject
arm group label: Study day 1
other name: PeptoPro
intervention type: Dietary Supplement
intervention name: Hydrolyzed casein protein + carbohydrates
description: Amount provided is based on the fat-free mass of subject
arm group label: Study day 2
other name: PeptoPro + maltodextrin
intervention type: Dietary Supplement
intervention name: Hydrolyzed casein protein + leucine
description: Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)
arm group label: Study day 3
other name: PeptoPro + leucine
intervention type: Dietary Supplement
intervention name: Hydrolyzed casein protein + carbohydrates + leucine
description: Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)
arm group label: Study day 4
other name: PeptoPro + maltodextrin + leucine
intervention type: Dietary Supplement
intervention name: 4 levels of hydrolyzed casein protein + carbohydrates
description: Amount provided is based on the fat-free mass of subject. The 4 levels are: 0, 0.02, 0.05, 0.15 g casein protein/kg fat free mass/hr. The ratio between protein and carbohydrates is fixed.
arm group label: Study Day 5
other name: 4 levels of PeptoPro + maltodextrin
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marielle PK Engelen, PhD
role: Principal Investigator
affiliation: Texas A&M University
facility: 
country: United States
url: https://www.dsm.com/markets/foodandbeverages/en_US/products/nutraceuticals/peptopro.html
description: PeptoPro
responsible party type: Principal Investigator
investigator affiliation: Texas A&M University
investigator full name: Marielle PKJ Engelen, PhD
investigator title: PhD
mesh term: Caseins