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

NCT05997628 | Unknown DMC

• 1 other identifier: CH2301-A-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NAD+/NADH in Peripheral Blood Monitoring

Keywords

NADH; NAD+

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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

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

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

Interventions

Detection of NAD+/NADH concentration of Peripheral Blood Samples OTHER

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.

18-40 years; 41-60 years; 61-80 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \. Male/females of 18 to 85 years of age.
• \. Able to provide written Informed Consent.
• \. Body Mass Index ranging from 18 to 25 kg/m2(bounds included), with a stable weight over the last 2 months (±2.5 kg).
• \. 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:

• \. Male/females of 18 to 85 years of age.
• \. Able to provide written Informed Consent.
• \. Body Mass Index ranging from 18 to 25 kg/m2(bounds included), with a stable weight over the last 2 months (±2.5 kg).
• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

Central Study Contacts

Zongchang Song

CONTACT

13703785735; songzc@shcell.com

shuan Liu

CONTACT

17749122881; liushuan@shcell.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 18, 2023
• Study Start: August 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)