<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/NCT03788577</url>
  </required_header>
  <id_info>
    <org_study_id>2018-05-004B</org_study_id>
    <nct_id>NCT03788577</nct_id>
  </id_info>
  <brief_title>Impact of Oligonol to Cardiometabolic Risk and Muscular Health</brief_title>
  <official_title>Impact of Oligonol to Cardiometabolic Risk and Muscular Health: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming University</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>
      This project will mainly focus on Middle and old-aged adults, and examine whether&#xD;
      Cardiovascular and metabolic risks can be reduced. In the meanwhile, this project will&#xD;
      develop strategies for improving muscle loss , muscle strength decline, and the quality life&#xD;
      of the elderly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular diseases are common among the elder. However, previous researches mainly focus&#xD;
      on observational research or small scale clinical trial, and the subjects are mainly youth.&#xD;
      Therefore, this project hope to understand whether Oligonol can reduce Cardiovascular and&#xD;
      metabolic risks among senior adults. Consequently,improve muscle loss muscle strength&#xD;
      decline, quality of old adults life. This project design may potentially develop new&#xD;
      strategies for curing Sarcopenia as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2018</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline muscle after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline muscle via MRI after 12 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline fat content of leg after 12 weeks</measure>
    <time_frame>baseline,12 weeks</time_frame>
    <description>Change from baseline fat content of leg via MRI after 12 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes form baseline chair-stand after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>measured by the time of chair-stand after 12 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes form baseline muscle strength after 12 weeks</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>measured by hand grip distance after 12 weeks.</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 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)</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 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 25-(OH)-Vit. D 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 protein after 12 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Muscle Loss</condition>
  <condition>Muscle Weakness</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Oligonol intake group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oligonol intake</intervention_name>
    <description>Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.</description>
    <arm_group_label>Oligonol intake group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People who aged more than 50 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 fallen down 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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Walking speed less than 0.3m/s&#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 (GFR &lt; 30 mL/min/1.73 m2 for at least 3&#xD;
             months)&#xD;
&#xD;
          -  People with visual impairment and hearing disorder who cannot complete the program.&#xD;
&#xD;
          -  People who are unable to undertake MRI&#xD;
&#xD;
          -  Any other condition that PI recognized as not suitable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liang-Kung Chen, MD.PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Healthy Longevity and Aging Sciences, National Yang Ming University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Veteran General Hospital</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 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</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>No</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/NCT03788577
org study id: 2018-05-004B
nct id: NCT03788577
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This project will mainly focus on Middle and old-aged adults, and examine whether
      Cardiovascular and metabolic risks can be reduced. In the meanwhile, this project will
      develop strategies for improving muscle loss , muscle strength decline, and the quality life
      of the elderly.
Cardiovascular diseases are common among the elder. However, previous researches mainly focus
      on observational research or small scale clinical trial, and the subjects are mainly youth.
      Therefore, this project hope to understand whether Oligonol can reduce Cardiovascular and
      metabolic risks among senior adults. Consequently,improve muscle loss muscle strength
      decline, quality of old adults life. This project design may potentially develop new
      strategies for curing Sarcopenia as well.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Changes from baseline muscle after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline muscle via MRI after 12 weeks.
measure: Changes from baseline fat content of leg after 12 weeks
time frame: baseline,12 weeks
description: Change from baseline fat content of leg via MRI after 12 weeks.
measure: Changes form baseline chair-stand after 12 weeks
time frame: baseline, 12 weeks
description: measured by the time of chair-stand after 12 weeks.
measure: Changes form baseline muscle strength after 12 weeks
time frame: baseline, 12 weeks
description: measured by hand grip distance after 12 weeks.
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 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)
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 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 25-(OH)-Vit. D 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 protein after 12 weeks
arm group label: Oligonol intake group
arm group type: Experimental
description: This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks.
arm group label: Placebo group
arm group type: Placebo Comparator
description: This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks.
intervention type: Dietary Supplement
intervention name: Oligonol intake
description: Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.
arm group label: Oligonol intake group
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Liang-Kung Chen, MD.PhD.
role: Principal Investigator
affiliation: Center for Healthy Longevity and Aging Sciences, National Yang Ming University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Muscle Weakness
sharing ipd: No