NAD+/NADH in Peripheral Blood MonitoringNCT05997628
The Exploratory Study on the Baseline Level of NAD+/NADH in Peripheral Blood Samples of Different Gender and Age Groups of Healthy Adults.
An observational study of NAD+/NADH in Peripheral Blood Monitoring, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- NAD+/NADH in Peripheral Blood Monitoring
- What is being tested?
- Detection of NAD+/NADH concentration of Peripheral Blood Samples
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Aug 2024
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults of different age groups under daily physiological and lifestyle conditions
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mengchao Cancer Hospital
Shanghai, Shanghai Municipality
zongchang SONG
About this study
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.
Read the 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.
- Conditions
- NAD+/NADH in Peripheral Blood Monitoring
- Being tested
- Detection of NAD+/NADH concentration of Peripheral Blood Samples
- Keywords
- NADH, NAD+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of NAD+/NADH concentration of Peripheral Blood SamplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Detection of NAD+/NADH concentration of Peripheral Blood Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The baseline in NAD+ and NADH concentrations in whole blood of healthy adults.
Monitor
Measured: 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
Measured: 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
Measured: 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
Measured: Fasting at 0 hour on the day of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAD+/NADH in Peripheral Blood MonitoringStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 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
- NCT05997628
- Sponsor's protocol ID
- CH2301-A-01
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 18 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05997628
- Acronym / sponsor ID
- CH2301-A-01
- Conditions
- NAD+/NADH in Peripheral Blood Monitoring
- Keywords
- NADH, NAD+
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 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
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 18 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18-40 years | – | Other: Detection of NAD+/NADH concentration of Peripheral Blood SamplesEach 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 |
| 41-60 years | – | Other: Detection of NAD+/NADH concentration of Peripheral Blood SamplesEach 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 |
| 61-80 years | – | Other: Detection of NAD+/NADH concentration of Peripheral Blood SamplesEach 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults of different age groups under daily physiological and lifestyle conditions
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Detection of NAD+/NADH concentration of Peripheral Blood SamplesPeripheral 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. | Other | 18-40 years, 41-60 years, 61-80 years |
Primary outcome
The baseline in NAD+ and NADH concentrations in whole blood of healthy adults.
Time frame: Fasting at 0 hour, 4 hour on the day of the trial
Monitor
Counting of blood cell indicators such as red blood cells, white blood cells, and platelets in healthy adults
Time frame: Fasting at 0 hour on the day of the trial
Monitor
Blood biochemical indicators of the healthy adults monitoring including liver function; lood lipids; blood sugar; renal function; uric acid; lactate dehydrogenase; creatine kinase, etc
Time frame: Fasting at 0 hour on the day of the trial
Monitor
Peripheral blood immune cell phenotype of the healthy adults monitoring including NK cells, B lymphocytes, eosinophils, T lymphocytes, platelet neutrophils, basophils, and monocytes, etc
Time frame: Fasting at 0 hour on the day of the trial
Monitor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: Yes
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?
An observational study of NAD+/NADH in Peripheral Blood Monitoring, 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 6 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 18 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.
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 (13703785735, songzc@shcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The baseline in NAD+ and NADH concentrations in whole blood of healthy adults. (time frame: Fasting at 0 hour, 4 hour on the day of the trial). The study lists 4 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 18 Aug 2023.