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

NCTNCT05984550Other idCH2301-A-02

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Overview

Status: Status unknown
Phase: Early phase 1
Enrollment: 10 participants (estimated)
Sponsor: Shanghai Cell Therapy Group Co.,Ltd · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
China
Start: Aug 2023 (estimated)
Primary completion: Mar 2024 (estimated)
Completion: Dec 2024 (estimated)
First posted: 9 Aug 2023
Last update posted: 21 Aug 2023
Conditions: Enhance Immune Function

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph Early 1
The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.
NCT05984550
est. Aug 2023 to est. Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

NMNDrug

Arms1

Experimental
treated group
NMN(Vital NAD) treated group

Primary outcomes7

Outcomes the sponsor listed as primary.

Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood.
Time frame · 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]
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
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
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
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
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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