Clinical trial NCT05984550: The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.
Official title: The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Enhance Immune Function
Keywords: NMN
NAD+
NADH
Lead sponsor: Shanghai Cell Therapy Group Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Mengchao Cancer Hospital
First posted: 2023-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Nicotinamide mononucleotide (Vital NAD) in whole blood.
timeFrame: before and after at least 30 days of treatment of Vital NAD
measure: Changes in NAD+ and NADH concentrations in whole blood.
timeFrame: 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.
timeFrame: 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.
timeFrame: 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.
timeFrame: 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.
timeFrame: 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.
timeFrame: before and after at least 30 days of treatment of Vital NAD
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mengchao Cancer Hospital
Study officials:
References: