<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/NCT03032237</url>
  </required_header>
  <id_info>
    <org_study_id>ConsuMEER onderzoek</org_study_id>
    <nct_id>NCT03032237</nct_id>
  </id_info>
  <brief_title>Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods</brief_title>
  <acronym>ConsuMEER</acronym>
  <official_title>Testing the Effectiveness and Acceptance of Home-delivered Protein-rich Meals and Foods on the Intake of Community-dwelling Older Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HAN University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HAS Hogeschool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre of Expertise Food (CoE Food)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sligro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>FrieslandCampina</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>HAN University of Applied Sciences</source>
  <oversight_info>
    <has_dmc>No</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>
      Rationale: Undernutrition risk among community-dwelling older adults in developed countries&#xD;
      is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well&#xD;
      as efficacious to reduce undernutrition in community-dwelling older adults. A promising&#xD;
      strategy to increase protein intake among older adults, is to offer dietary solutions with&#xD;
      normal foods that fit their current daily eating patterns. For this reason, home-delivered&#xD;
      protein-rich readymade meals and protein-rich dairy products will be studied in this&#xD;
      research.&#xD;
&#xD;
      Objective: The primary objective is to study the effectiveness of commercially available&#xD;
      protein-rich readymade meals and protein-rich dairy products in increasing protein intake of&#xD;
      older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary&#xD;
      objectives include: studying effects of these meals and dairy products on total daily energy&#xD;
      intake. Further, studying the acceptance of and compliance to the meals and dairy products.&#xD;
&#xD;
      Study design: The study will be performed as a single-blind randomized, controlled, four-week&#xD;
      trial in a real-life setting: in community-dwelling older adults' own homes.&#xD;
&#xD;
      Study population: The target group of this study are community-dwelling older adults who use&#xD;
      a meal-delivery service.&#xD;
&#xD;
      Intervention: Both groups will receive readymade meals for each day during 4 weeks. They will&#xD;
      also receive dairy products to freely consume during the intervention period. The&#xD;
      intervention groups receives protein-rich meals and protein-rich dairy products, the control&#xD;
      receives standard meals and food products.&#xD;
&#xD;
      Main study parameters/endpoints: Difference in daily protein intake between intervention and&#xD;
      control group. Secondary parameters: energy intake and acceptance (liking).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Protein intake</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference in daily protein intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Acceptance and liking of meals and food products; outcome will be measured with a questionnaire including a 5-point likert scale (for liking) and a question how much was eaten. This questionnaire needs to be done every day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference in daily energy intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Malnutrition; Protein</condition>
  <condition>Protein Malnutrition</condition>
  <arm_group>
    <arm_group_label>Protein-rich assortment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention groups receives protein-rich meals and protein-rich dairy products.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard assortment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group receives standard meals and food products.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional intervention - protein-rich</intervention_name>
    <description>Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.&#xD;
To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.&#xD;
Intervention group will receive protein-rich meals and protein-rich foods and drinks.</description>
    <arm_group_label>Protein-rich assortment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional intervention - standard</intervention_name>
    <description>Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.&#xD;
To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.&#xD;
Control group will receive standard (not protein-rich) meals and standard foods and drinks.</description>
    <arm_group_label>Standard assortment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 65 years or over&#xD;
&#xD;
          -  Living at home&#xD;
&#xD;
          -  Be a client of maaltijdservice.nl&#xD;
&#xD;
          -  Being able to eat by themselves&#xD;
&#xD;
          -  Have a microwave to heat meals&#xD;
&#xD;
          -  Live in Nijmegen or Den Bosch area&#xD;
&#xD;
          -  Being able to understand, read and speak Dutch&#xD;
&#xD;
          -  Having signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Legally incapacitated&#xD;
&#xD;
          -  Mini Mental State Examination (MMSE) score &lt; 24&#xD;
&#xD;
          -  Following a diet with protein restriction or a vegetarian diet&#xD;
&#xD;
          -  Allergies or intolerances prohibiting the use of dairy products&#xD;
&#xD;
          -  Only using texture modified foods (liquid diet)&#xD;
&#xD;
          -  Diagnosed by doctor with renal insufficiency&#xD;
&#xD;
          -  Suffering from a terminal illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marian de van der Schueren, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HAN University of Applied Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Annet Roodenburg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HAS Hogeschool</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HAN University of Applied Sciences</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HAN University of Applied Sciences</investigator_affiliation>
    <investigator_full_name>dr. Marian de van der Schueren</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Protein intake</keyword>
  <keyword>Older adults</keyword>
  <keyword>Protein-rich</keyword>
  <keyword>Acceptance</keyword>
  <keyword>Liking</keyword>
  <keyword>Readymade meals</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Kwashiorkor</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared.</ipd_description>
  </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/NCT03032237
org study id: ConsuMEER onderzoek
nct id: NCT03032237
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: Undernutrition risk among community-dwelling older adults in developed countries
      is shown to be around 24%. Increasing protein intake is a strategy that is feasible as well
      as efficacious to reduce undernutrition in community-dwelling older adults. A promising
      strategy to increase protein intake among older adults, is to offer dietary solutions with
      normal foods that fit their current daily eating patterns. For this reason, home-delivered
      protein-rich readymade meals and protein-rich dairy products will be studied in this
      research.

      Objective: The primary objective is to study the effectiveness of commercially available
      protein-rich readymade meals and protein-rich dairy products in increasing protein intake of
      older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. Secondary
      objectives include: studying effects of these meals and dairy products on total daily energy
      intake. Further, studying the acceptance of and compliance to the meals and dairy products.

      Study design: The study will be performed as a single-blind randomized, controlled, four-week
      trial in a real-life setting: in community-dwelling older adults' own homes.

      Study population: The target group of this study are community-dwelling older adults who use
      a meal-delivery service.

      Intervention: Both groups will receive readymade meals for each day during 4 weeks. They will
      also receive dairy products to freely consume during the intervention period. The
      intervention groups receives protein-rich meals and protein-rich dairy products, the control
      receives standard meals and food products.

      Main study parameters/endpoints: Difference in daily protein intake between intervention and
      control group. Secondary parameters: energy intake and acceptance (liking).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Protein intake
time frame: 4 weeks
description: Difference in daily protein intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.
measure: Acceptance
time frame: 4 weeks
description: Acceptance and liking of meals and food products; outcome will be measured with a questionnaire including a 5-point likert scale (for liking) and a question how much was eaten. This questionnaire needs to be done every day.
measure: Energy intake
time frame: 4 weeks
description: Difference in daily energy intake between intervention and control group assessed with 3-day food records which will be checked by trained dietitians.
arm group label: Protein-rich assortment
arm group type: Experimental
description: The intervention groups receives protein-rich meals and protein-rich dairy products.
arm group label: Standard assortment
arm group type: Placebo Comparator
description: The control group receives standard meals and food products.
intervention type: Other
intervention name: Nutritional intervention - protein-rich
description: Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.
To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.
Intervention group will receive protein-rich meals and protein-rich foods and drinks.
arm group label: Protein-rich assortment
intervention type: Other
intervention name: Nutritional intervention - standard
description: Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.
To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.
Control group will receive standard (not protein-rich) meals and standard foods and drinks.
arm group label: Standard assortment
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marian de van der Schueren, PhD
role: Principal Investigator
affiliation: HAN University of Applied Sciences
last name: Annet Roodenburg, PhD
role: Principal Investigator
affiliation: HAS Hogeschool
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: HAN University of Applied Sciences
investigator full name: dr. Marian de van der Schueren
investigator title: Prof. Dr.
mesh term: Malnutrition
mesh term: Kwashiorkor
sharing ipd: No
ipd description: IPD will not be shared.