The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.

August 17, 2023 updated by: Shanghai Cell Therapy Group Co.,Ltd
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Shanghai Mengchao Cancer Hospital
        • Contact:
          • Zongchang Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male/females of 18 to 80 years of age.
  2. Able to provide written Informed Consent.
  3. BMI 25.0-44.9 kg/m².
  4. Able to follow verbal and written study directions.
  5. Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
  6. Able to maintain consistent diet and lifestyle habits according to the study.

Exclusion Criteria:

  • 1. Diabetes.

    2.Premenopausal or menopause <1 year.

    3.Persons who have received hormone replacement therapy within the past 6 months.

    4.Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.

    5.Unstable weight (>3% change during the last 2 months before entering the study).

    6.Significant organ system dysfunction or disease.

    7.Present cancer or history of cancer that has been in remission for <5 years.

    8.Polycystic ovary syndrome.

    9.Major psychiatric illness.

    10.Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study.

    11.Metal implants.

    12.Persons who consume >14 units of alcohol per week.

    13.Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treated group
NMN(Vital NAD) treated group
Drug: NMN

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+.

Other Names:
  • Nicotinamide mononucleotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood.
Time Frame: before and after at least 30 days of treatment of Vital NAD
before and after at least 30 days of treatment of Vital NAD
Changes in NAD+ and NADH concentrations in whole blood.
Time Frame: before and after at least 30 days of treatment of Vital NAD]
before and after at least 30 days of treatment of Vital NAD]
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
before and after at least 30 days of treatment of Vital NAD
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
before and after at least 30 days of treatment of Vital NAD
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
before and after at least 30 days of treatment of Vital NAD
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
before and after at least 30 days of treatment of Vital NAD
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
before and after at least 30 days of treatment of Vital NAD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Cell Therapy Group Co.,Ltd

Collaborators

Shanghai Mengchao Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH2301-A-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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