<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/NCT01677273</url>
  </required_header>
  <id_info>
    <org_study_id>B299</org_study_id>
    <nct_id>NCT01677273</nct_id>
  </id_info>
  <brief_title>The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite</brief_title>
  <acronym>HerKulES</acronym>
  <official_title>The Effect of Hydrolyzed Casein on Energy Expenditure and Subjective Appetite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ministry of Science, Technology and Innovation, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arla Foods</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Danish Dairy Research Foundation, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>FrieslandCampina</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim is to examine and compare the effects of hydrolyzed casein (HC), intact&#xD;
      casein (IC) and intact whey protein (IWP) on diet-induced thermogenesis (DIT). Furthermore,&#xD;
      to study the effects on appetite regulation assessed by subjective appetite sensations, ad&#xD;
      libitum energy intake and appetite regulating hormones.&#xD;
&#xD;
      Whey and casein differ in absorption and digestion rate, with whey being a fast protein and&#xD;
      casein being a slow protein. When casein undergoes hydrolysis the absorption and digestion&#xD;
      rates approaches the rates of whey. In the present study the importance of absorption rate&#xD;
      and amino acid composition, in regards to energy expenditure and appetite regulation, will be&#xD;
      examined. HC and IC have identical amino acid composition, but differ in absorption rate,&#xD;
      whereas HC and IWP have similar absorption rates, but differ in amino acid composition. We&#xD;
      hypothesize that consumption of HC will increase DIT and fat oxidation to a greater extend&#xD;
      that IC. Moreover, that HC and IWP will increase satiety shortly after protein consumption,&#xD;
      whereas IC will be more satiating after several hours.&#xD;
&#xD;
      The study is a controlled, randomized, 3-arm crossover study. It consists of three visits in&#xD;
      a respiratory chamber separated by at least two weeks. 26 healthy, overweight and obese (BMI&#xD;
      27-35 kg/m2) young men will be enrolled and randomized to the order of the three protein&#xD;
      supplements (HC, IC or IWP). At each visit protein supplements (containing either HC, IC or&#xD;
      IWP) will be served as breakfast, lunch and dinner. Respiratory measures will be obtained&#xD;
      over 24 hours and appetite will be assessed by visual analogue scales and appetite regulating&#xD;
      hormones. Furthermore, ad libitum energy intake will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diet-induced thermogenesis</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appetite assessed by visual analogue scales</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite assessed by ad libitum energy intake</measure>
    <time_frame>1 single meal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite regulating hormones in plasma</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations)</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in insulin, glucose and atrial natriuretic peptide</measure>
    <time_frame>4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ad libitum energy intake assessed by 24 hour dietary records</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NMR-spectroscopy based metabonomics profiling of urin</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Increased Energy Expenditure</condition>
  <condition>Increased Satiety</condition>
  <arm_group>
    <arm_group_label>Hydrolyzed casein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrolyzed casein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intact casein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intact casein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intact whey protein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intact whey protein</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrolyzed casein</intervention_name>
    <description>30 g protein/supplement, 4 supplements/visit</description>
    <arm_group_label>Hydrolyzed casein</arm_group_label>
    <other_name>Hyvital casein CMA 500, Friesland Campina</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intact casein</intervention_name>
    <description>30 g protein/supplement, 4 supplements/visit</description>
    <arm_group_label>Intact casein</arm_group_label>
    <other_name>Miprodan 30, Arla Foods</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intact whey protein</intervention_name>
    <description>30 g protein/supplement, 4 supplements/visit</description>
    <arm_group_label>Intact whey protein</arm_group_label>
    <other_name>Lacprodan SP-9225 Instant, Arla Foods</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy young men and woman&#xD;
&#xD;
          -  Overweight and obese (BMI 27-35 kg/m2)&#xD;
&#xD;
          -  18-40 years&#xD;
&#xD;
          -  Women must have a regular menstrual cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to dairy products or other food components&#xD;
&#xD;
          -  Vegetarians&#xD;
&#xD;
          -  Weight change &gt;3kg within 2 months prior to start of the study&#xD;
&#xD;
          -  Use of alcohol &gt;14 drinks/wk&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Physically active &gt;10 hrs/wk&#xD;
&#xD;
          -  Use of over-the-counter or prescription medication that influences body weight,&#xD;
             appetite or metabolism&#xD;
&#xD;
          -  Diabetes Mellitus&#xD;
&#xD;
          -  Dyslipidemia&#xD;
&#xD;
          -  Diseases, which influence metabolism&#xD;
&#xD;
          -  Donation of blood 3 months prior to start of the study&#xD;
&#xD;
          -  Subjects with a hemoglobin value &lt; 8 mol/L (measured at screening)&#xD;
&#xD;
          -  Subjects with a blood glucose level &gt; 6.1 mmol/l (110 mg/dl) (measured at screening)&#xD;
&#xD;
          -  Subjects who are unable to give an informed consent.&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arne Astrup, Prof., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Human Nutrition, Faculty of Science, University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Human Nutrion</name>
      <address>
        <city>Frederiksberg</city>
        <zip>1958</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>July 26, 2013</last_update_submitted>
  <last_update_submitted_qc>July 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>AAstrup</investigator_full_name>
    <investigator_title>Prof., MD, Head of Department, Department of Human Nutrition</investigator_title>
  </responsible_party>
  <keyword>Respiratory chambers</keyword>
  <keyword>Energy expenditure</keyword>
  <keyword>Appetite</keyword>
  <keyword>Dairy proteins</keyword>
  <keyword>Diet induced thermogenesis</keyword>
  <keyword>Obesity</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/NCT01677273
org study id: B299
nct id: NCT01677273
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The primary aim is to examine and compare the effects of hydrolyzed casein (HC), intact
      casein (IC) and intact whey protein (IWP) on diet-induced thermogenesis (DIT). Furthermore,
      to study the effects on appetite regulation assessed by subjective appetite sensations, ad
      libitum energy intake and appetite regulating hormones.

      Whey and casein differ in absorption and digestion rate, with whey being a fast protein and
      casein being a slow protein. When casein undergoes hydrolysis the absorption and digestion
      rates approaches the rates of whey. In the present study the importance of absorption rate
      and amino acid composition, in regards to energy expenditure and appetite regulation, will be
      examined. HC and IC have identical amino acid composition, but differ in absorption rate,
      whereas HC and IWP have similar absorption rates, but differ in amino acid composition. We
      hypothesize that consumption of HC will increase DIT and fat oxidation to a greater extend
      that IC. Moreover, that HC and IWP will increase satiety shortly after protein consumption,
      whereas IC will be more satiating after several hours.

      The study is a controlled, randomized, 3-arm crossover study. It consists of three visits in
      a respiratory chamber separated by at least two weeks. 26 healthy, overweight and obese (BMI
      27-35 kg/m2) young men will be enrolled and randomized to the order of the three protein
      supplements (HC, IC or IWP). At each visit protein supplements (containing either HC, IC or
      IWP) will be served as breakfast, lunch and dinner. Respiratory measures will be obtained
      over 24 hours and appetite will be assessed by visual analogue scales and appetite regulating
      hormones. Furthermore, ad libitum energy intake will be assessed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Diet-induced thermogenesis
time frame: 24 hours
measure: Appetite assessed by visual analogue scales
time frame: 24 hours
measure: Appetite assessed by ad libitum energy intake
time frame: 1 single meal
measure: Appetite regulating hormones in plasma
time frame: 4 hours
measure: Components of respiratory measures (basal metabolic rate, sleeping metabolic rate and substrate oxidations)
time frame: 24 hours
measure: Differences in insulin, glucose and atrial natriuretic peptide
time frame: 4 hours
measure: Ad libitum energy intake assessed by 24 hour dietary records
time frame: 24 hours
measure: NMR-spectroscopy based metabonomics profiling of urin
time frame: 24 hours
arm group label: Hydrolyzed casein
arm group type: Active Comparator
description: Hydrolyzed casein
arm group label: Intact casein
arm group type: Active Comparator
description: Intact casein
arm group label: Intact whey protein
arm group type: Active Comparator
description: Intact whey protein
intervention type: Dietary Supplement
intervention name: Hydrolyzed casein
description: 30 g protein/supplement, 4 supplements/visit
arm group label: Hydrolyzed casein
other name: Hyvital casein CMA 500, Friesland Campina
intervention type: Dietary Supplement
intervention name: Intact casein
description: 30 g protein/supplement, 4 supplements/visit
arm group label: Intact casein
other name: Miprodan 30, Arla Foods
intervention type: Dietary Supplement
intervention name: Intact whey protein
description: 30 g protein/supplement, 4 supplements/visit
arm group label: Intact whey protein
other name: Lacprodan SP-9225 Instant, Arla Foods
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arne Astrup, Prof., MD
role: Principal Investigator
affiliation: Department of Human Nutrition, Faculty of Science, University of Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: AAstrup
investigator title: Prof., MD, Head of Department, Department of Human Nutrition
mesh term: Caseins