xml: <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/NCT05985369</url>
    </required_header>
    <id_info>
      <org_study_id>524790</org_study_id>
      <nct_id>NCT05985369</nct_id>
    </id_info>
    <brief_title>Vegan and Omnivorous Diets and Skeletal Muscle Turnover in Healthy Older Adults</brief_title>
    <acronym>MVP</acronym>
    <official_title>The Effects of a High-quality Vegan Diet on Skeletal Muscle Maintenance and Adaptation in Comparison to a Protein-matched Omnivorous Diet in Healthy Older Adults.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Exeter</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Exeter</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>
        Dietary protein intake and physical activity are key to minimise the age-related loss of&#xD;
        skeletal muscle mass. While animal-derived protein sources are considered high-quality&#xD;
        anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support&#xD;
        skeletal muscle maintenance and healthy ageing. The aim of the present study is to assess the&#xD;
        effect of a vegan diet on daily muscle protein synthesis rates compared to a protein-matched&#xD;
        omnivorous diet where the majority of protein is derived from high-quality animal-based&#xD;
        protein sources.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The age-related loss of muscle mass and strength is (partly) explained by a&#xD;
        blunted responsiveness of skeletal muscle to the anabolic properties of dietary protein and&#xD;
        muscle contraction. Therefore, sufficient dietary protein intake and physical activity are&#xD;
        required to minimise age-related muscle atrophy. It remains unknown whether this can be&#xD;
        achieved utilising non-animal-derived (vegan) protein sources.&#xD;
  &#xD;
        Objective: To assess daily muscle protein synthesis rates when adopting a vegan or&#xD;
        protein-matched omnivorous control diet.&#xD;
  &#xD;
        Methods: Healthy older adults (aged 60-80 years) will be randomly allocated to a completely&#xD;
        controlled 1-week vegan (providing 0.8 g/kg BW/day protein) or protein-matched omnivorous&#xD;
        diet. During this week, participants will perform a set of unilateral leg resistance exercise&#xD;
        on day 1, 3, and 5. Deuterium oxide in combination with saliva and muscle sample (from the m.&#xD;
        vastus lateralis) collection will be used to measure daily muscle protein synthesis rates in&#xD;
        resting and exercised tissue.&#xD;
  &#xD;
        Value: This will be the first study assessing daily muscle protein turnover in healthy older&#xD;
        adults adopting a 1-week vegan diet. This will contribute to the understanding and viability&#xD;
        of vegan protein to support active and healthy ageing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 9, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Muscle protein synthesis (MPS) in resting and exercised tissue</measure>
      <time_frame>7 days</time_frame>
      <description>Daily MPS rates, expressed as fractional synthetic rate (%/h)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Muscle morphology</measure>
      <time_frame>7 days</time_frame>
      <description>Changes in muscle thickness during the intervention period, measured via ultrasound</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Healthy Aging</condition>
    <arm_group>
      <arm_group_label>Vegan diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be allocated to a fully controlled 1-week vegan diet containing 0.8 g/kg BW/day of protein where all protein provided will be derived from non-animal-derived protein sources.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Omnivorous diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be allocated to a fully controlled 1-week omnivorous diet containing 0.8 g/kg BW/day of protein where the majority of protein will be derived from animal-derived protein sources.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Controlled diet and resistance exercise</intervention_name>
      <description>Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.</description>
      <arm_group_label>Omnivorous diet</arm_group_label>
      <arm_group_label>Vegan diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI between 18.5 - 30&#xD;
  &#xD;
            -  Active (not very sedentary and not master athlete; assessed via IPAQ)&#xD;
  &#xD;
            -  Women only: post menopause&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hypertension (&gt;150/90 mmHg)&#xD;
  &#xD;
            -  Any diagnosed metabolic impairment&#xD;
  &#xD;
            -  Any diagnosed cardiovascular disease&#xD;
  &#xD;
            -  Any diagnosed gastrointestinal disease&#xD;
  &#xD;
            -  Diagnosed cancer&#xD;
  &#xD;
            -  Any medication known to affect muscle metabolism (e.g. hormone replacement therapy)&#xD;
  &#xD;
            -  Severe food allergies or intolerances (e.g. celiac, lactose intolerance, allergic to&#xD;
               fungi or algae foods)&#xD;
  &#xD;
            -  Smoking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ino van der Heijden, MSc</last_name>
      <phone>+441392724774</phone>
      <email>iv234@exeter.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Benjamin Wall, Prof</last_name>
      <phone>+441392724774</phone>
      <email>B.T.Wall@exeter.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Exeter</name>
        <address>
          <city>Exeter</city>
          <state>Devond</state>
          <zip>EX1 2LU</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Muscle metabolism</keyword>
    <keyword>Protein metabolism</keyword>
    <keyword>Sarcopenia</keyword>
    <keyword>Resistance exercise</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985369
  org study id: 524790
  nct id: NCT05985369
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Dietary protein intake and physical activity are key to minimise the age-related loss of
        skeletal muscle mass. While animal-derived protein sources are considered high-quality
        anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support
        skeletal muscle maintenance and healthy ageing. The aim of the present study is to assess the
        effect of a vegan diet on daily muscle protein synthesis rates compared to a protein-matched
        omnivorous diet where the majority of protein is derived from high-quality animal-based
        protein sources.
  Background: The age-related loss of muscle mass and strength is (partly) explained by a
        blunted responsiveness of skeletal muscle to the anabolic properties of dietary protein and
        muscle contraction. Therefore, sufficient dietary protein intake and physical activity are
        required to minimise age-related muscle atrophy. It remains unknown whether this can be
        achieved utilising non-animal-derived (vegan) protein sources.
  
        Objective: To assess daily muscle protein synthesis rates when adopting a vegan or
        protein-matched omnivorous control diet.
  
        Methods: Healthy older adults (aged 60-80 years) will be randomly allocated to a completely
        controlled 1-week vegan (providing 0.8 g/kg BW/day protein) or protein-matched omnivorous
        diet. During this week, participants will perform a set of unilateral leg resistance exercise
        on day 1, 3, and 5. Deuterium oxide in combination with saliva and muscle sample (from the m.
        vastus lateralis) collection will be used to measure daily muscle protein synthesis rates in
        resting and exercised tissue.
  
        Value: This will be the first study assessing daily muscle protein turnover in healthy older
        adults adopting a 1-week vegan diet. This will contribute to the understanding and viability
        of vegan protein to support active and healthy ageing.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Muscle protein synthesis (MPS) in resting and exercised tissue
  time frame: 7 days
  description: Daily MPS rates, expressed as fractional synthetic rate (%/h)
  measure: Muscle morphology
  time frame: 7 days
  description: Changes in muscle thickness during the intervention period, measured via ultrasound
  arm group label: Vegan diet
  arm group type: Experimental
  description: Participants will be allocated to a fully controlled 1-week vegan diet containing 0.8 g/kg BW/day of protein where all protein provided will be derived from non-animal-derived protein sources.
  arm group label: Omnivorous diet
  arm group type: Experimental
  description: Participants will be allocated to a fully controlled 1-week omnivorous diet containing 0.8 g/kg BW/day of protein where the majority of protein will be derived from animal-derived protein sources.
  intervention type: Other
  intervention name: Controlled diet and resistance exercise
  description: Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.
  arm group label: Omnivorous diet
  arm group label: Vegan diet
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ino van der Heijden, MSc
  phone: +441392724774
  email: iv234@exeter.ac.uk
  last name: Benjamin Wall, Prof
  phone: +441392724774
  email: B.T.Wall@exeter.ac.uk
  facility: 
  status: Recruiting
  country: United Kingdom
  responsible party type: Sponsor