Clinical trial NCT05997628: The Exploratory Study on the Baseline Level of NAD+/NADH in Peripheral Blood Samples of Different Gender and Age Groups of Healthy Adults.
Official title: The Exploratory Study on the Baseline Level of NAD+/NADH in Peripheral Blood Samples of Different Gender and Age Groups of Healthy Adults.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NAD+/NADH in Peripheral Blood Monitoring
Keywords: NADH
NAD+
Lead sponsor: Shanghai Cell Therapy Group Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Mengchao Cancer Hospital
First posted: 2023-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults of different age groups under daily physiological and lifestyle conditions

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The baseline in NAD+ and NADH concentrations in whole blood of healthy adults.
timeFrame: Fasting at 0 hour, 4 hour on the day of the trial
measure: Counting of blood cell indicators such as red blood cells, white blood cells, and platelets in healthy adults
timeFrame: Fasting at 0 hour on the day of the trial
measure: Blood biochemical indicators of the healthy adults monitoring including liver function; lood lipids; blood sugar; renal function; uric acid; lactate dehydrogenase; creatine kinase, etc
timeFrame: Fasting at 0 hour on the day of the trial
measure: Peripheral blood immune cell phenotype of the healthy adults monitoring including NK cells, B lymphocytes, eosinophils, T lymphocytes, platelet neutrophils, basophils, and monocytes, etc
timeFrame: Fasting at 0 hour on the day of the trial
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mengchao Cancer Hospital
state: Shanghai
Study officials:
References: