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/NCT05984550</url>
    </required_header>
    <id_info>
      <org_study_id>CH2301-A-02</org_study_id>
      <nct_id>NCT05984550</nct_id>
    </id_info>
    <brief_title>The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.</brief_title>
    <official_title>The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Cell Therapy Group Co.,Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanghai Mengchao Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Cell Therapy Group Co.,Ltd</source>
    <oversight_info>
      <has_dmc>Yes</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 purpose of this study is to investigate the changes in adult peripheral blood immune cell&#xD;
        subpopulations, subpopulations, and cell functional status before and after intervention with&#xD;
        Nicotinamide Mononucleotide (Vital NAD ) as NAD+ supplement for a certain period of time。To&#xD;
        Explore and validate the biological functions of Nicotinamide Mononucleotide (Vital NAD ) of&#xD;
        rejuvenation of the Peripheral blood immune cells of Adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study focuses on the effects of Nicotinamide mononucleotide (Vital NAD) as NAD+&#xD;
        supplement on the subtypes and biological functions of immune cells of Adults, especially the&#xD;
        types and subsets of immune cells, immune cell differentiation, and immune cell status&#xD;
        indicators. Therefore, this study plans to enroll approximately 20 adult subjects in a daily&#xD;
        dose of 600mg/day and receive 30 days of Nicotinamide Mononucleotide (Vital NAD)&#xD;
        intervention. The study will evaluate the improvement effect of NMN intervention on human&#xD;
        immune cell research indicators before and after intervention. The study will also study the&#xD;
        impact of NMN on Hematology and blood biochemical indicators, and evaluate the changes of&#xD;
        human Hematology biological age after NMN intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood.</measure>
      <time_frame>before and after at least 30 days of treatment of Vital NAD</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in NAD+ and NADH concentrations in whole blood.</measure>
      <time_frame>before and after at least 30 days of treatment of Vital NAD]</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of Blood cell indicators TBNK cells of the healthy adults at the points before and after intervention.</measure>
      <time_frame>before and after at least 30 days of treatment of Vital NAD</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of Blood biochemical indicators of the healthy adults at the points before and after intervention.</measure>
      <time_frame>before and after at least 30 days of treatment of Vital NAD</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of Peripheral blood immune T cells phenotype of the healthy adults at baseline.</measure>
      <time_frame>before and after at least 30 days of treatment of Vital NAD</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of Tnaïve, Tscm, Tcm and Tem in peripheral blood of the healthy adults at the points before and after intervention.</measure>
      <time_frame>before and after at least 30 days of treatment of Vital NAD</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of SITR1 expression in immune cells of peripheral blood at the points before and after intervention.</measure>
      <time_frame>before and after at least 30 days of treatment of Vital NAD</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Enhance Immune Function</condition>
    <arm_group>
      <arm_group_label>treated group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NMN(Vital NAD) treated group</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>NMN</intervention_name>
      <description>NMN (Nicotinamide Mononucleotide) is a naturally occurring bioactive nucleotide with the full name of Nicotinamide mononucleotide. Its structure can be divided into α and β Two isomers, of which only β- NMN is a naturally occurring form with biological activity.&#xD;
  In human body, NMN is the precursor of NAD+(Nicotinamide adenine dinucleotide, also known as coenzyme I), and its function is mainly reflected through NAD+.</description>
      <arm_group_label>treated group</arm_group_label>
      <other_name>Nicotinamide mononucleotide</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male/females of 18 to 80 years of age.&#xD;
  &#xD;
            2. Able to provide written Informed Consent.&#xD;
  &#xD;
            3. BMI 25.0-44.9 kg/m².&#xD;
  &#xD;
            4. Able to follow verbal and written study directions.&#xD;
  &#xD;
            5. Must not be taking or be willing to take any supplements containing any form of niacin&#xD;
               for seven days prior to baseline and for the duration of the study.&#xD;
  &#xD;
            6. Able to maintain consistent diet and lifestyle habits according to the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Diabetes.&#xD;
  &#xD;
               2.Premenopausal or menopause &lt;1 year.&#xD;
  &#xD;
               3.Persons who have received hormone replacement therapy within the past 6 months.&#xD;
  &#xD;
               4.Persons who take vitamin B supplementation and are not willing to discontinue&#xD;
               supplementation for 3 weeks before and during the entire study period.&#xD;
  &#xD;
               5.Unstable weight (&gt;3% change during the last 2 months before entering the study).&#xD;
  &#xD;
               6.Significant organ system dysfunction or disease.&#xD;
  &#xD;
               7.Present cancer or history of cancer that has been in remission for &lt;5 years.&#xD;
  &#xD;
               8.Polycystic ovary syndrome.&#xD;
  &#xD;
               9.Major psychiatric illness.&#xD;
  &#xD;
               10.Use of medications known to affect study outcome measures (e.g., steroid) or&#xD;
               increase the risk of study procedures (e.g., anticoagulants) that cannot be&#xD;
               temporarily discontinued for the study.&#xD;
  &#xD;
               11.Metal implants.&#xD;
  &#xD;
               12.Persons who consume &gt;14 units of alcohol per week.&#xD;
  &#xD;
               13.Unable or unwilling to follow the study protocol or who, for any reason, is&#xD;
               considered an inappropriate candidate for the study by the research team.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zongchang Song</last_name>
      <phone>+86-13703785735</phone>
      <email>songzc@shcell.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>shuan Liu</last_name>
      <phone>17749122881</phone>
      <email>liushuan@shcell.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shanghai Mengchao Cancer Hospital</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zongchang Song</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NMN</keyword>
    <keyword>NAD+</keyword>
    <keyword>NADH</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Niacinamide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- 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/NCT05984550
  org study id: CH2301-A-02
  nct id: NCT05984550
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to investigate the changes in adult peripheral blood immune cell
        subpopulations, subpopulations, and cell functional status before and after intervention with
        Nicotinamide Mononucleotide (Vital NAD ) as NAD+ supplement for a certain period of time。To
        Explore and validate the biological functions of Nicotinamide Mononucleotide (Vital NAD ) of
        rejuvenation of the Peripheral blood immune cells of Adults.
  This study focuses on the effects of Nicotinamide mononucleotide (Vital NAD) as NAD+
        supplement on the subtypes and biological functions of immune cells of Adults, especially the
        types and subsets of immune cells, immune cell differentiation, and immune cell status
        indicators. Therefore, this study plans to enroll approximately 20 adult subjects in a daily
        dose of 600mg/day and receive 30 days of Nicotinamide Mononucleotide (Vital NAD)
        intervention. The study will evaluate the improvement effect of NMN intervention on human
        immune cell research indicators before and after intervention. The study will also study the
        impact of NMN on Hematology and blood biochemical indicators, and evaluate the changes of
        human Hematology biological age after NMN intervention.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood.
  time frame: before and after at least 30 days of treatment of Vital NAD
  measure: Changes in NAD+ and NADH concentrations in whole blood.
  time frame: before and after at least 30 days of treatment of Vital NAD]
  measure: The change of Blood cell indicators TBNK cells of the healthy adults at the points before and after intervention.
  time frame: before and after at least 30 days of treatment of Vital NAD
  measure: The change of Blood biochemical indicators of the healthy adults at the points before and after intervention.
  time frame: before and after at least 30 days of treatment of Vital NAD
  measure: The change of Peripheral blood immune T cells phenotype of the healthy adults at baseline.
  time frame: before and after at least 30 days of treatment of Vital NAD
  measure: The change of Tnaïve, Tscm, Tcm and Tem in peripheral blood of the healthy adults at the points before and after intervention.
  time frame: before and after at least 30 days of treatment of Vital NAD
  measure: The change of SITR1 expression in immune cells of peripheral blood at the points before and after intervention.
  time frame: before and after at least 30 days of treatment of Vital NAD
  arm group label: treated group
  arm group type: Experimental
  description: NMN(Vital NAD) treated group
  intervention type: Drug
  intervention name: NMN
  description: NMN (Nicotinamide Mononucleotide) is a naturally occurring bioactive nucleotide with the full name of Nicotinamide mononucleotide. Its structure can be divided into α and β Two isomers, of which only β- NMN is a naturally occurring form with biological activity.
  In human body, NMN is the precursor of NAD+(Nicotinamide adenine dinucleotide, also known as coenzyme I), and its function is mainly reflected through NAD+.
  arm group label: treated group
  other name: Nicotinamide mononucleotide
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zongchang Song
  phone: +86-13703785735
  email: songzc@shcell.com
  last name: shuan Liu
  phone: 17749122881
  email: liushuan@shcell.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Niacinamide
  sharing ipd: Yes
  ipd info type: Clinical Study Report (CSR)