<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/NCT03784456</url>
  </required_header>
  <id_info>
    <org_study_id>19-001-A-2</org_study_id>
    <nct_id>NCT03784456</nct_id>
  </id_info>
  <brief_title>Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults</brief_title>
  <official_title>Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laurel Corporation, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Yang Ming University</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>
      The subjects of this intervention program are mainly based on community-dwelling mid-aged and&#xD;
      older adults. The investigator's program will provide meals containing different&#xD;
      proportionated protein.As this project is a double blind test, only the investigators will&#xD;
      know which subject corresponding to specific group of diets.&#xD;
&#xD;
      Besides, the investigators use the valued-based healthcare standard set as well as the Center&#xD;
      for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive&#xD;
      Assesment ,and Mini Nutritional Assessment as outcome measures and to use the randomized&#xD;
      controlled trial design to validate if increased protein density diet could improve the&#xD;
      vitality and health of mid-aged and old adults .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With aging, functions of every organs become to decline. Muscle mass, is one of the decline.&#xD;
      According to previous research, adults would lose 40% among from aged 20 to 70. If muscle&#xD;
      mass decline combining with the decline of muscle strength is so called Sarcopenia.When&#xD;
      muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In&#xD;
      addition, activity and life quality are also responsible for falling, cognitive difficulty,&#xD;
      disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia&#xD;
      through this program and develop prevention strategy and model to mollify the the negative&#xD;
      effect of rapid aging society.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>
    <intervention_model_description>This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The program is designed as a double blind test, randomized intervention. Which meant that neither the subjects nor the PI and co-PI would not know which kind of diet they're going to obtain. Only investigators and test provider would know the meals corresponding to respective groups of subjects.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline muscle strength after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>measured by hand grip</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes form baseline QUALITY OF LIFE after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Nutrition intake after 12 weeks</measure>
    <time_frame>baseline, 12 weeks.</time_frame>
    <description>measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline depression after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline cognitive ability after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline endurance after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>measured by 6-minute walk distance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline walking speed after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>measured by six-meter walking speed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline timed up and go test after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>measured by timed up and go test (TUG) and six-meter walking speed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline numbers of Complete blood count after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline numbers of Complete blood count after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Albumin after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Albumin after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of blood urea nitrogen after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of blood urea nitrogen after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Creatinin after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Creatinin after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Fasting glucose after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Fasting glucose after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Fasting insulin after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Fasting insulin after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Total Cholesterol after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Total Cholesterol after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Triglyceride after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of Triglyceride after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of dehydroepiandrosterone after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline concentration of dehydroepiandrosterone after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of Leptin after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change from baseline concentration of Leptin after 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline concentration of urine protein after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change from baseline concentration of urine routine after 12 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Muscle Loss</condition>
  <condition>Muscle Weakness</condition>
  <condition>Fragility</condition>
  <arm_group>
    <arm_group_label>25% protein group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This experimental arm will be given meals containing 25% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>15% protein group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This control arm will be given meals containing 15% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>25% protein</intervention_name>
    <description>Compared to usual group of 15% protein in meals, intervention group will receive 25% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.</description>
    <arm_group_label>25% protein group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>15% protein</intervention_name>
    <description>Designed as comparator , compared to empirical arm of 25% protein in meals, intervention group will receive 15% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.</description>
    <arm_group_label>15% protein group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People who aged 40-75 years&#xD;
&#xD;
          -  Patients with following characteristics:&#xD;
&#xD;
          -  feeling loss in activity&#xD;
&#xD;
          -  detecting decline in self's walking speed.&#xD;
&#xD;
          -  feeling tired of doing everything.&#xD;
&#xD;
          -  having fell in last year.&#xD;
&#xD;
          -  People can accept undergoing MRI&#xD;
&#xD;
          -  People willing to follow the program and cooperate with us for following tracking.&#xD;
&#xD;
          -  People who are neither vegan nor vegetarian&#xD;
&#xD;
          -  People agree and be able to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is&#xD;
             allergic to our diets.&#xD;
&#xD;
          -  People with any disease affecting their limbs, including:&#xD;
&#xD;
          -  having fracture on limbs in the past 6 months&#xD;
&#xD;
          -  having severe arthritis in the past 6 months&#xD;
&#xD;
          -  any other whom PI recognized as weak control of their nervous system( e.g.:&#xD;
             Parkinson's disease and stroke).&#xD;
&#xD;
          -  People with intermittent limp caused by peripheral artery diseases&#xD;
&#xD;
          -  People with weak control of mental disorder&#xD;
&#xD;
          -  People with weak control of Cardiopulmonary disease&#xD;
&#xD;
          -  People with weak control of Malignant tumor&#xD;
&#xD;
          -  People with weak control of kidney diseases (eGFR &lt;60ml/min/1.73)&#xD;
&#xD;
          -  People with Visual impairment and Hearing disorder which cannot help to complete the&#xD;
             program.&#xD;
&#xD;
          -  People who are unable to undertake MRI&#xD;
&#xD;
          -  People who have underwent hormone treatment and planned to undergo hormone treatment&#xD;
             during program session.&#xD;
&#xD;
          -  Any other condition that PI recognized as not suitable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liang-Kung Chen, MD.PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aging and Health Research Center, National Yang Ming University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Yang Ming University</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</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/NCT03784456
org study id: 19-001-A-2
nct id: NCT03784456
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The subjects of this intervention program are mainly based on community-dwelling mid-aged and
      older adults. The investigator's program will provide meals containing different
      proportionated protein.As this project is a double blind test, only the investigators will
      know which subject corresponding to specific group of diets.

      Besides, the investigators use the valued-based healthcare standard set as well as the Center
      for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive
      Assesment ,and Mini Nutritional Assessment as outcome measures and to use the randomized
      controlled trial design to validate if increased protein density diet could improve the
      vitality and health of mid-aged and old adults .
With aging, functions of every organs become to decline. Muscle mass, is one of the decline.
      According to previous research, adults would lose 40% among from aged 20 to 70. If muscle
      mass decline combining with the decline of muscle strength is so called Sarcopenia.When
      muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In
      addition, activity and life quality are also responsible for falling, cognitive difficulty,
      disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia
      through this program and develop prevention strategy and model to mollify the the negative
      effect of rapid aging society.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.
primary purpose: Prevention
masking: Single (Participant)
masking description: The program is designed as a double blind test, randomized intervention. Which meant that neither the subjects nor the PI and co-PI would not know which kind of diet they're going to obtain. Only investigators and test provider would know the meals corresponding to respective groups of subjects.
measure: Changes from baseline muscle strength after 12 weeks
time frame: baseline,12 weeks
description: measured by hand grip
measure: Changes form baseline QUALITY OF LIFE after 12 weeks
time frame: baseline, 12 weeks
description: measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition
measure: Change from baseline Nutrition intake after 12 weeks
time frame: baseline, 12 weeks.
description: measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
measure: Change from baseline depression after 12 weeks
time frame: baseline,12 weeks
description: measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition
measure: Change from baseline cognitive ability after 12 weeks
time frame: baseline, 12 weeks
description: measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
measure: Change from baseline endurance after 12 weeks
time frame: baseline, 12 weeks
description: measured by 6-minute walk distance
measure: Change from baseline walking speed after 12 weeks
time frame: baseline, 12 weeks
description: measured by six-meter walking speed
measure: Change from baseline timed up and go test after 12 weeks
time frame: baseline, 12 weeks
description: measured by timed up and go test (TUG) and six-meter walking speed
measure: Change from baseline numbers of Complete blood count after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline numbers of Complete blood count after 12 weeks
measure: Change from baseline concentration of Albumin after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Albumin after 12 weeks
measure: Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
measure: Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
measure: Change from baseline concentration of blood urea nitrogen after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of blood urea nitrogen after 12 weeks
measure: Change from baseline concentration of Creatinin after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Creatinin after 12 weeks
measure: Change from baseline concentration of Fasting glucose after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Fasting glucose after 12 weeks
measure: Change from baseline concentration of Fasting insulin after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Fasting insulin after 12 weeks
measure: Change from baseline concentration of Total Cholesterol after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Total Cholesterol after 12 weeks
measure: Change from baseline concentration of Triglyceride after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of Triglyceride after 12 weeks
measure: Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
measure: Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
measure: Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
measure: Change from baseline concentration of dehydroepiandrosterone after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline concentration of dehydroepiandrosterone after 12 weeks
measure: Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
time frame: baseline, 12 weeks
description: Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
measure: Change from baseline concentration of Leptin after 12 weeks
time frame: baseline, 12 weeks
description: Change from baseline concentration of Leptin after 12 weeks
measure: Change from baseline concentration of urine protein after 12 weeks
time frame: baseline, 12 weeks
description: Change from baseline concentration of urine routine after 12 weeks
arm group label: 25% protein group
arm group type: Experimental
description: This experimental arm will be given meals containing 25% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks.
arm group label: 15% protein group
arm group type: Active Comparator
description: This control arm will be given meals containing 15% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks.
intervention type: Dietary Supplement
intervention name: 25% protein
description: Compared to usual group of 15% protein in meals, intervention group will receive 25% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.
arm group label: 25% protein group
intervention type: Dietary Supplement
intervention name: 15% protein
description: Designed as comparator , compared to empirical arm of 25% protein in meals, intervention group will receive 15% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.
arm group label: 15% protein group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Liang-Kung Chen, MD.PhD.
role: Principal Investigator
affiliation: Aging and Health Research Center, National Yang Ming University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Muscle Weakness
sharing ipd: Undecided