The Exploratory Study on the Baseline Level of NAD+/NADH in Peripheral Blood Samples of Different Gender and Age Groups of Healthy Adults.

This study investigates the concentration levels of NAD+/NADH in peripheral blood samples and immune cells of healthy adults of different age groups under daily physiological and lifestyle conditions, in order to determine the baseline levels of NAD+/NADH in adult populations of different age groups and genders. Simultaneously examining the biological status and function of human immune cells, blood biochemistry, biological age levels, to explore the biological function and mechanism of NAD+/NADH in the aging process of the human body.

Study Overview

• Status: Not yet recruiting
• Conditions: NAD+/NADH in Peripheral Blood Monitoring
• Intervention / Treatment: Other: Detection of NAD+/NADH concentration of Peripheral Blood Samples

Detailed Description

In this study, 60 subjects will be enrolled in three groups according to the age range of 20-40, 41-60 and 61-80. Each group has 20 subjects, and the sex ratio of each group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups. At the same time, the subjects tested Hematology, blood biochemical indicators, as well as the expression of subsets of peripheral blood immune cells and SIRT1 level at the same time point, to study the change trend of NAD+/NADH level in different age groups, and the correlation between this trend and Hematology age, immune indicators.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: shuan Liu; Phone Number: 17749122881; Email: liushuan@shcell.com
• Study Contact Backup: Name: Zongchang Song; Phone Number: 13703785735; Email: songzc@shcell.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy adults of different age groups under daily physiological and lifestyle conditions

Description

Inclusion Criteria:

• 1. Male/females of 18 to 85 years of age.

  2. Able to provide written Informed Consent.

  3. Body Mass Index ranging from 18 to 25 kg/m2(bounds included), with a stable weight over the last 2 months (±2.5 kg).

  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. Male/females of 18 to 85 years of age.

  2. Able to provide written Informed Consent.

  3. Body Mass Index ranging from 18 to 25 kg/m2(bounds included), with a stable weight over the last 2 months (±2.5 kg).

  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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
18-40 years; Each group has 20 subjects, and the sex ratio of 18-40 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups	Other: Detection of NAD+/NADH concentration of Peripheral Blood Samples; Peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels, hematology, blood biochemical indicators, immune cells and SIRT1 level in peripheral blood in different age groups. This experiment monitors indicators mentioned above without any drug intervention.
41-60 years; Each group has 20 subjects, and the sex ratio of 41-60 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups	Other: Detection of NAD+/NADH concentration of Peripheral Blood Samples; Peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels, hematology, blood biochemical indicators, immune cells and SIRT1 level in peripheral blood in different age groups. This experiment monitors indicators mentioned above without any drug intervention.
61-80 years; Each group has 20 subjects, and the sex ratio of 61-80 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups	Other: Detection of NAD+/NADH concentration of Peripheral Blood Samples; Peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels, hematology, blood biochemical indicators, immune cells and SIRT1 level in peripheral blood in different age groups. This experiment monitors indicators mentioned above without any drug intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The baseline in NAD+ and NADH concentrations in whole blood of healthy adults.	Monitor	Fasting at 0 hour, 4 hour on the day of the trial
Counting of blood cell indicators such as red blood cells, white blood cells, and platelets in healthy adults	Monitor	Fasting at 0 hour on the day of the trial
Blood biochemical indicators of the healthy adults monitoring including liver function; lood lipids; blood sugar; renal function; uric acid; lactate dehydrogenase; creatine kinase, etc	Monitor	Fasting at 0 hour on the day of the trial
Peripheral blood immune cell phenotype of the healthy adults monitoring including NK cells, B lymphocytes, eosinophils, T lymphocytes, platelet neutrophils, basophils, and monocytes, etc	Monitor	Fasting at 0 hour on the day of the trial

Collaborators and Investigators

• Sponsor: Shanghai Cell Therapy Group Co.,Ltd
• Collaborators: Shanghai Mengchao Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: NAD+; NADH
• Other Study ID Numbers: CH2301-A-01

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