<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/NCT02218333</url>
  </required_header>
  <id_info>
    <org_study_id>2014/150/REK sør-øst C</org_study_id>
    <nct_id>NCT02218333</nct_id>
  </id_info>
  <brief_title>Health Effects of Milk Proteins in Elderly Subjects</brief_title>
  <official_title>Effect of Milk Proteins on Body Composition, Muscle Strength, Inflammation and Bone Health in Elderly Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian School of Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to investigate effects of milk on body composition and muscle&#xD;
      strength, inflammation, appetite, DNA damage/repair and PBMC whole genome transcriptomics in&#xD;
      elderly subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in muscle mass, strength and performance</measure>
    <time_frame>Measured at baseline and after 12 weeks (end-of-study visit)</time_frame>
    <description>Change in muscle is mass measured by DXA. Muscle strength and performance are measured by several physical tests such as repeated chair stands, handgrip strength, step stair test and strength in legs and torso and gait speed and are considered as the clinical relevant outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in levels of inflammatory markers</measure>
    <time_frame>Measured at baseline and after 12 weeks (end-of-study visit)</time_frame>
    <description>Changes in levels of inflammatory markers in circulation and at PBMC gene Expression Level such as i.e. CRP, IL-6, TNFa, IL-8, IL-18, ICAM, VCAM.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Effect on PBMC whole genome transcriptomics</measure>
    <time_frame>Measured at baseline and after 12 weeks (end-of-study visit)</time_frame>
    <description>Measurement of PBMC Whole genome transcriptomics will be performed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in body composition (including bone mineral density)</measure>
    <time_frame>Measured at baseline and after 12 weeks (end-of-study visit)</time_frame>
    <description>Changes in body composition are measured by DXA.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in the level of appetite regulatory hormones</measure>
    <time_frame>Measured at baseline and after 12 weeks (end-of-study visit)</time_frame>
    <description>Changes in the level of appetite regulatory hormones such as i.e. adiponectin, glucagon-like protein (GLP-1), gastric inhibitory polypeptide (GIP), ghrelin, Peptide YY (PYY) and cholecystokinin (CCK)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in the Lymphocyte DNA damage and repair system</measure>
    <time_frame>Measured at baseline and after 12 weeks (end-of-study visit)</time_frame>
    <description>Changes will be measured using Whole blood and PBMC.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Control drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>An isocaloric drink to milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protein enriched milk (Styrk)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milk</intervention_name>
    <description>4 dl milk will be consumed daily with breakfast and supper for 12 weeks</description>
    <arm_group_label>Milk</arm_group_label>
    <other_name>TINE Styrk milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Control drink</arm_group_label>
    <other_name>Isocaloric drink</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 70 years of age&#xD;
&#xD;
          -  reduced gait speed or&#xD;
&#xD;
          -  reduced &quot;five times sit to stand test&quot; or&#xD;
&#xD;
          -  reduced &quot;timed step stair test &quot; or&#xD;
&#xD;
          -  reduced grip strength&#xD;
&#xD;
          -  Stable body weight (last 3 months)&#xD;
&#xD;
          -  Mini Nutritional Assessment (MNA®) score ≥ 17&#xD;
&#xD;
          -  Mini-mental status (MMSE-NR) score: ≥ 24&#xD;
&#xD;
          -  Willing to participate according to the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy/intolerance to milk/dairy products&#xD;
&#xD;
          -  High intake of milk and yoghurt&#xD;
&#xD;
          -  Physical active subjects&#xD;
&#xD;
          -  Known diabetes type I or II, or HbA1c ≥ 6,5%&#xD;
&#xD;
          -  Recent events of acute cardiovascular disease including stroke&#xD;
&#xD;
          -  Rapidly evolving diseases (active malignancy) or history of cancer (malignant tumors)&#xD;
             last 3 years.&#xD;
&#xD;
          -  Severe inflammation-related diseases such as e.g. Crohn disease and arthritis&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Increased blood pressure&#xD;
&#xD;
          -  High intake of alcohol&#xD;
&#xD;
          -  Reduced kidney function (GFR &lt; 45 ml/min)&#xD;
&#xD;
          -  Increased hsCRP, ASAT, ALAT&#xD;
&#xD;
          -  Increased or suppressed TSH&#xD;
&#xD;
          -  Hormone therapy&#xD;
&#xD;
          -  Systemic use of glucocorticosteroids (anti-inflammatory steroid hormones). Use of&#xD;
             spray and inhalator use is not exclusion.&#xD;
&#xD;
          -  Disability preventing physical tests&#xD;
&#xD;
          -  Using medications known to affect protein metabolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kirsten Holven, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <state>Post box 1046, Blindern</state>
        <zip>0317</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 15, 2015</last_update_submitted>
  <last_update_submitted_qc>October 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Kirsten Holven</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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/NCT02218333
org study id: 2014/150/REK sør-øst C
nct id: NCT02218333
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of the present study is to investigate effects of milk on body composition and muscle
      strength, inflammation, appetite, DNA damage/repair and PBMC whole genome transcriptomics in
      elderly subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in muscle mass, strength and performance
time frame: Measured at baseline and after 12 weeks (end-of-study visit)
description: Change in muscle is mass measured by DXA. Muscle strength and performance are measured by several physical tests such as repeated chair stands, handgrip strength, step stair test and strength in legs and torso and gait speed and are considered as the clinical relevant outcomes.
measure: Changes in levels of inflammatory markers
time frame: Measured at baseline and after 12 weeks (end-of-study visit)
description: Changes in levels of inflammatory markers in circulation and at PBMC gene Expression Level such as i.e. CRP, IL-6, TNFa, IL-8, IL-18, ICAM, VCAM.
measure: Effect on PBMC whole genome transcriptomics
time frame: Measured at baseline and after 12 weeks (end-of-study visit)
description: Measurement of PBMC Whole genome transcriptomics will be performed.
measure: Changes in body composition (including bone mineral density)
time frame: Measured at baseline and after 12 weeks (end-of-study visit)
description: Changes in body composition are measured by DXA.
measure: Changes in the level of appetite regulatory hormones
time frame: Measured at baseline and after 12 weeks (end-of-study visit)
description: Changes in the level of appetite regulatory hormones such as i.e. adiponectin, glucagon-like protein (GLP-1), gastric inhibitory polypeptide (GIP), ghrelin, Peptide YY (PYY) and cholecystokinin (CCK)
measure: Changes in the Lymphocyte DNA damage and repair system
time frame: Measured at baseline and after 12 weeks (end-of-study visit)
description: Changes will be measured using Whole blood and PBMC.
arm group label: Control drink
arm group type: Placebo Comparator
description: An isocaloric drink to milk
arm group label: Milk
arm group type: Experimental
description: Protein enriched milk (Styrk)
intervention type: Dietary Supplement
intervention name: Milk
description: 4 dl milk will be consumed daily with breakfast and supper for 12 weeks
arm group label: Milk
other name: TINE Styrk milk
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Control drink
other name: Isocaloric drink
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kirsten Holven, Professor
role: Principal Investigator
affiliation: Institute of Basic Medical Sciences, Faculty of medicine, University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Kirsten Holven
investigator title: Professor