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

NCT05984550 | Unknown Early Phase 1 DMC

• 1 other identifier: CH2301-A-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enhance Immune Function

Keywords

NMN; NAD+; NADH

Outcome Measures

Primary Outcomes (7)

• Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood.

  before and after at least 30 days of treatment of Vital NAD

• Changes in NAD+ and NADH concentrations in whole blood.

  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.

  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.

  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.

  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.

  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.

  before and after at least 30 days of treatment of Vital NAD

Study Arms (1)

treated group

EXPERIMENTAL

NMN(Vital NAD) treated group

Drug: NMN

Interventions

NMN DRUG

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+.

Also known as: Nicotinamide mononucleotide

treated group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/females of 18 to 80 years of age.
• Able to provide written Informed Consent.
• BMI 25.0-44.9 kg/m².
• Able to follow verbal and written study directions.
• 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.
• Able to maintain consistent diet and lifestyle habits according to the study.

You may not qualify if:

• \. Diabetes.
• Premenopausal or menopause \<1 year.
• Persons who have received hormone replacement therapy within the past 6 months.
• Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
• Unstable weight (\>3% change during the last 2 months before entering the study).
• Significant organ system dysfunction or disease.
• Present cancer or history of cancer that has been in remission for \<5 years.
• Polycystic ovary syndrome.
• Major psychiatric illness.
• 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.
• Metal implants.
• Persons who consume \>14 units of alcohol per week.
• 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.

Sponsors & Collaborators

• Shanghai Cell Therapy Group Co.,Ltd: lead
• Shanghai Mengchao Cancer Hospital: collaborator

Study Sites (1)

Shanghai Mengchao Cancer Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Nicotinamide Mononucleotide

Intervention Hierarchy (Ancestors)

Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Zongchang Song

CONTACT

+86-13703785735; songzc@shcell.com

shuan Liu

CONTACT

17749122881; liushuan@shcell.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)