Enhance Immune FunctionEarly Phase 1NCT05984550
The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.
A Early Phase 1 study testing NMN in people with Enhance Immune Function, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Enhance Immune Function
- What is being tested?
- NMN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Enhance Immune Function
- Being tested
- NMN
- Keywords
- NMN, NAD+, NADH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMNDrug
Also called Nicotinamide mononucleotide
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+.
| Study group | Role | What they receive |
|---|---|---|
| treated group | Experimental | NMN(Vital NAD) treated group Receives: Drug: NMN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood.
Measured: before and after at least 30 days of treatment of Vital NAD
Changes in NAD+ and NADH concentrations in whole blood.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before and after at least 30 days of treatment of Vital NAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhance Immune FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cell Therapy Group Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Mengchao Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984550
- Sponsor's protocol ID
- CH2301-A-02
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.
- ClinicalTrials.gov ID
- NCT05984550
- Acronym / sponsor ID
- CH2301-A-02
- Conditions
- Enhance Immune Function
- Keywords
- NMN, NAD+, NADH
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Cell Therapy Group Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Mengchao Cancer Hospital
- Study start
- Aug 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated group | Experimental | Drug: NMNNMN(Vital NAD) treated group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMNAlso: Nicotinamide mononucleotideNMN (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+. | Drug | treated group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NMN in people with Enhance Immune Function, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zongchang Song (+86-13703785735, songzc@shcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood. (time frame: before and after at least 30 days of treatment of Vital NAD). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.