<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/NCT04496856</url>
  </required_header>
  <id_info>
    <org_study_id>ValleKollagen</org_study_id>
    <nct_id>NCT04496856</nct_id>
  </id_info>
  <brief_title>Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients</brief_title>
  <official_title>The Effects of Whey Protein and Collagen on Fat Free Mass, Muscle Strength and Wound Healing in Elderly Patients Undergoing Elective Knee- or Hip Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Herlev and Gentofte Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the effect of whey protein and collagen on fat free&#xD;
      mass, muscle strength, functional ability, wound healing and life quality in elderly patients&#xD;
      undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The&#xD;
      patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in fat free mass</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>The outcome will be monitored through BIA and the development of fat free mass in the operated leg will be compared to the development of fat free mass in the non-operated leg.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>The amount of days until the wound is healed (defined as: the epithelium is covered without crust). This will be monitored trough pictures and assessed on a scale from 1-5 by a masked doctor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Redness and infection</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handgrip strength</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extension strength of quadriceps femoris</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>Measured in amounts of repetitions of 0.5 or 1.0 kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life quality</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>Measured trough EuroQol-5D-5L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in functional ability (NMS)</measure>
    <time_frame>Weekly 30 days</time_frame>
    <description>Assessed by New mobility score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Chair stand test</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>Measured by amount of repetitions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Palatability of the protein supplementation</measure>
    <time_frame>30 days</time_frame>
    <description>Assessed on a scale from 1-5</description>
  </other_outcome>
  <other_outcome>
    <measure>Consistency of the protein supplementation</measure>
    <time_frame>30 days</time_frame>
    <description>Assessed on a scale from 1-5</description>
  </other_outcome>
  <other_outcome>
    <measure>Compliance of the protein supplementation intake</measure>
    <time_frame>Weekly for 30 days</time_frame>
    <description>Assessed trough a weekly form, which the participants will fill in</description>
  </other_outcome>
  <other_outcome>
    <measure>Rapported side effects</measure>
    <time_frame>30 days</time_frame>
    <description>Participants will be informed to rapport if they experience any side effects throughout the intervention</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Hip Arthritis</condition>
  <condition>Sarcopenia</condition>
  <condition>Knee Arthritis</condition>
  <arm_group>
    <arm_group_label>Collagen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whey Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of this arm are going to consume 30 g of whey protein daily for 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey protein and Collagen supplementation</intervention_name>
    <description>Participants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored.</description>
    <arm_group_label>Collagen</arm_group_label>
    <arm_group_label>Whey Protein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65+ years&#xD;
&#xD;
          -  Scheduled elective knee- or hip surgery&#xD;
&#xD;
          -  Must be able to understand and speak danish&#xD;
&#xD;
          -  Must be able to chew and swallow food with a regular consistency&#xD;
&#xD;
          -  Must be able to consume the assigned protein supplementation&#xD;
&#xD;
          -  Must be able to consent participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vegan&#xD;
&#xD;
          -  Demensia&#xD;
&#xD;
          -  Critical complications to the surgery which prevents the patient from participating in&#xD;
             the rehabilitation program&#xD;
&#xD;
          -  Plasma-creatinin above 250 micromol/L&#xD;
&#xD;
          -  Palliative patients&#xD;
&#xD;
          -  Known intolerance of whey protein and/or collagen&#xD;
&#xD;
          -  Patients with a pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Herlev/Gentofte Hospital</name>
      <address>
        <city>Gentofte</city>
        <state>Hellerup</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jens Rikardt Andersen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Hip Arthroplasty</keyword>
  <keyword>Collagen</keyword>
  <keyword>Whey protein</keyword>
  <keyword>Knee Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04496856
org study id: ValleKollagen
nct id: NCT04496856
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to compare the effect of whey protein and collagen on fat free
      mass, muscle strength, functional ability, wound healing and life quality in elderly patients
      undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The
      patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: The difference in fat free mass
time frame: Weekly for 30 days
description: The outcome will be monitored through BIA and the development of fat free mass in the operated leg will be compared to the development of fat free mass in the non-operated leg.
measure: Wound healing
time frame: Weekly for 30 days
description: The amount of days until the wound is healed (defined as: the epithelium is covered without crust). This will be monitored trough pictures and assessed on a scale from 1-5 by a masked doctor.
measure: Redness and infection
time frame: Weekly for 30 days
description: The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.
measure: Handgrip strength
time frame: Weekly for 30 days
description: Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage
measure: Extension strength of quadriceps femoris
time frame: Weekly for 30 days
description: Measured in amounts of repetitions of 0.5 or 1.0 kg.
measure: Life quality
time frame: Weekly for 30 days
description: Measured trough EuroQol-5D-5L
measure: Difference in functional ability (NMS)
time frame: Weekly 30 days
description: Assessed by New mobility score
measure: Difference in Chair stand test
time frame: Weekly for 30 days
description: Measured by amount of repetitions
measure: Palatability of the protein supplementation
time frame: 30 days
description: Assessed on a scale from 1-5
measure: Consistency of the protein supplementation
time frame: 30 days
description: Assessed on a scale from 1-5
measure: Compliance of the protein supplementation intake
time frame: Weekly for 30 days
description: Assessed trough a weekly form, which the participants will fill in
measure: Rapported side effects
time frame: 30 days
description: Participants will be informed to rapport if they experience any side effects throughout the intervention
arm group label: Collagen
arm group type: Experimental
description: Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days
arm group label: Whey Protein
arm group type: Experimental
description: Participants of this arm are going to consume 30 g of whey protein daily for 30 days
intervention type: Dietary Supplement
intervention name: Whey protein and Collagen supplementation
description: Participants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored.
arm group label: Collagen
arm group label: Whey Protein
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jens Rikardt Andersen
investigator title: Associate Professor
mesh term: Arthritis
mesh term: Sarcopenia
sharing ipd: Undecided