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ImmunosenescenceNCT06907329

The Impact of Nicotinamide Mononucleotide Sustained-release Tablets on Immunosenescence and Metabolism in Middle-aged and Elderly Individuals With Metabolic Disorders.

A study testing NMN in people with Immunosenescence and Overweight, run by Qing Su at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates whether nicotinamide mononucleotide (NMN) sustained-release tablets affect markers of immune system aging in adults aged 50 to 70 years with overweight or obesity and metabolic disorders. It compares NMN, 1,000 mg once daily for 26 weeks, with a matching placebo. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Immunosenescence, Overweight, Obesity
What is being tested?
NMN
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteChina
Study dates
5 Jun 2025to 18 Oct 2026
Phase
Interventional
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 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) Age 50-70 years with overweight or obesity (BMI ≥ 24 kg/m²);
  • (2) At least one of the following three: metabolism-related fatty liver disease (diagnosed by ultrasound); pre-diabetes; type 2 diabetes mellitus with HbA1c <7% without glucose-lowering drug therapy;
  • (3) Agreed to participate in the trial and could adhere to the follow-up and visit the hospital on their own; signed the informed consent form.

Who cannot join

  • (1) Patients with tumours;
  • (2) Patients with autoimmune diseases (excluding Hashimoto's thyroiditis);
  • (3) Severe cardiovascular disease or cardiac insufficiency;
  • (4) Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg;
  • (5) Chronic obstructive pulmonary disease;
  • (6) Chronic active hepatitis or cirrhosis;
Show all 15Show fewer
  • (7) Chronic renal insufficiency;
  • (8) Stroke patients;
  • (9) Severe haematological diseases;
  • (10) Infectious diseases;
  • (11) Mental illness;
  • (12) Other conditions that, in the opinion of the investigator, may affect the results of the study;
  • (13) Those who have used NMN or other anti-aging agents within six months;
  • (14) Premenopausal women;
  • (15) ALT, AST values are more than three times higher than the upper limit of the normal reference range;

Trial locations and contacts

1 site in 1 country.

China1 site
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

Other trials in China

About this study

This study evaluates whether nicotinamide mononucleotide (NMN) sustained-release tablets affect markers of immune system aging in adults aged 50 to 70 years with overweight or obesity and metabolic disorders. It compares NMN, 1,000 mg once daily for 26 weeks, with a matching placebo. The main assessment is the change from baseline in the proportion of a blood T-cell population associated with immune system aging. The study also evaluates liver fat, blood sugar regulation, body composition, other immune and metabolic markers, and cardiorespiratory fitness, together with laboratory measures of safety.

Read the detailed description

This single-center, randomized, placebo-controlled, parallel-group study evaluates the effects of nicotinamide mononucleotide (NMN) sustained-release tablets on immunosenescence and metabolism in adults aged 50 to 70 years with overweight or obesity and metabolic disorders. A total of 124 participants were enrolled. Participants were randomly assigned to receive NMN sustained-release tablets (1,000 mg per tablet) or matching placebo, one tablet daily before breakfast for 26 weeks. Study visits were scheduled at months 1, 3, and 6.

The primary outcome is the change from baseline to Week 26 in the percentage of CD3+CD8+CD27-CD28- T cells among total CD3+CD8+ T cells in peripheral blood, measured by flow cytometry. The change is calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

Secondary assessments include other T-cell phenotypes, the CD8/CD4 ratio expressed as a percentage, hepatic steatosis, glucose metabolism, pancreatic beta-cell function, insulin resistance, body composition, anthropometric measures, whole-blood NMN and NAD+ concentrations, relative telomere length, and cardiorespiratory fitness. Hepatic steatosis is assessed using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) and the controlled attenuation parameter (CAP) measured by FibroScan. Body composition outcomes, assessed by dual-energy X-ray absorptiometry (DXA), are total body fat mass, total body tissue fat percentage, total body lean mass, estimated visceral adipose tissue mass, and relative skeletal muscle index. Cardiorespiratory fitness outcomes, assessed by cardiopulmonary exercise testing, are peak oxygen uptake and oxygen uptake at the anaerobic threshold. Each secondary outcome is assessed as the change from baseline to Week 26 and analyzed separately.

Safety assessments include routine blood and urine tests and liver and kidney function tests.

Being tested
NMN, Placebo
Keywords
Nicotinamide mononucleotide, NMN, NAD+, T-cell senescence, CD28, Aging
Medical subject headings
Overweight, Obesity, Prediabetic State, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NMNDietary supplement

    Nicotinamide mononucleotide (NMN) sustained-release tablets, 1,000 mg per tablet, administered orally as one tablet once daily before breakfast for 26 weeks.

  • PlaceboDietary supplement

    Matching placebo tablets, administered orally as one tablet once daily before breakfast for 26 weeks.

Study groups in NCT06907329
Study groupRoleWhat they receive
NMN ArmExperimentalParticipants assigned to the NMN arm receive one sustained-release tablet containing 1,000 mg of nicotinamide mononucleotide orally once daily before breakfast for 26 weeks.
Receives: Dietary Supplement: NMN
Placebo ArmPlacebo comparatorParticipants assigned to the placebo arm receive one matching placebo tablet orally once daily before breakfast for 26 weeks.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 26 in the Percentage of CD3+CD8+CD27-CD28- T Cells Among Total CD3+CD8+ T Cells

    The percentage of CD3+CD8+CD27-CD28- T cells among total CD3+CD8+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

Secondary outcomes (29)
  1. Change From Baseline to Week 26 in the Percentage of CD3+CD8+CD27- T Cells Among Total CD3+CD8+ T Cells

    The percentage of CD3+CD8+CD27- T cells among total CD3+CD8+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  2. Change From Baseline to Week 26 in the Percentage of CD3+CD8+CD28- T Cells Among Total CD3+CD8+ T Cells

    The percentage of CD3+CD8+CD28- T cells among total CD3+CD8+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  3. Change From Baseline to Week 26 in the Percentage of CD3+CD4+CD27- T Cells Among Total CD3+CD4+ T Cells

    The percentage of CD3+CD4+CD27- T cells among total CD3+CD4+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  4. Change From Baseline to Week 26 in the Percentage of CD3+CD4+CD28- T Cells Among Total CD3+CD4+ T Cells

    The percentage of CD3+CD4+CD28- T cells among total CD3+CD4+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  5. Change From Baseline to Week 26 in the Percentage of CD3+CD4+CD27-CD28- T Cells Among Total CD3+CD4+ T Cells

    The percentage of CD3+CD4+CD27-CD28- T cells among total CD3+CD4+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  6. Change From Baseline to Week 26 in the Percentage of CD3+CD8+CD45RA+CCR7- T Cells Among Total CD3+CD8+ T Cells

    The percentage of CD3+CD8+CD45RA+CCR7- T cells (TEMRA cells) among total CD3+CD8+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  7. Change From Baseline to Week 26 in the Percentage of CD3+CD8+CD57+KLRG1+ T Cells Among Total CD3+CD8+ T Cells

    The percentage of CD3+CD8+CD57+KLRG1+ T cells among total CD3+CD8+ T cells in peripheral blood will be measured by flow cytometry. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  8. Change From Baseline to Week 26 in the CD3+CD8+ to CD3+CD4+ T-Cell Ratio Expressed as a Percentage

    CD3+CD8+ and CD3+CD4+ T cells in peripheral blood will be quantified by flow cytometry. The CD8/CD4 ratio will be expressed as a percentage by dividing the number of CD3+CD8+ T cells by the number of CD3+CD4+ T cells and multiplying by 100. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  9. Change From Baseline to Week 26 in Liver Fat Content Assessed by MRI-PDFF

    Liver fat content will be assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) and expressed as a percentage. Change from baseline will be calculated as the Week 26 MRI-PDFF percentage minus the baseline MRI-PDFF percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  10. Change From Baseline to Week 26 in Controlled Attenuation Parameter (CAP)

    Hepatic steatosis will be assessed using the controlled attenuation parameter (CAP) measured by FibroScan and expressed in dB/m. Change from baseline will be calculated as the Week 26 CAP value minus the baseline CAP value.

    Measured: Baseline and Week 26

  11. Change From Baseline to Week 26 in Fasting Blood Glucose

    Fasting blood glucose will be measured in venous blood and expressed in mmol/L. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  12. Change From Baseline to Week 26 in 2-Hour Blood Glucose During an Oral Glucose Tolerance Test

    Blood glucose at 2 hours during an oral glucose tolerance test (OGTT) will be measured in venous blood and expressed in mmol/L. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  13. Change From Baseline to Week 26 in Glycated Hemoglobin (HbA1c)

    Glycated hemoglobin (HbA1c) will be measured in whole blood and expressed as a percentage (%) of total hemoglobin. Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  14. Change From Baseline to Week 26 in HOMA-beta

    Pancreatic beta-cell function will be assessed using the homeostasis model assessment of beta-cell function (HOMA-beta), calculated from fasting glucose and fasting insulin and reported as an index. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  15. Change From Baseline to Week 26 in HOMA-IR

    Insulin resistance will be assessed using the homeostasis model assessment of insulin resistance (HOMA-IR), calculated from fasting glucose and fasting insulin and reported as a unitless index. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  16. Change From Baseline to Week 26 in Total Body Fat Mass Assessed by DXA

    Total body fat mass will be measured by whole-body dual-energy X-ray absorptiometry (DXA) and expressed in g. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  17. Change From Baseline to Week 26 in Total Body Tissue Fat Percentage Assessed by DXA

    Total body tissue fat percentage (fat mass as a percentage of total tissue mass) will be measured by whole-body dual-energy X-ray absorptiometry (DXA). Change from baseline will be calculated as the Week 26 percentage minus the baseline percentage and expressed in percentage points.

    Measured: Baseline and Week 26

  18. Change From Baseline to Week 26 in Total Body Lean Mass Assessed by DXA

    Total body lean mass will be measured by whole-body dual-energy X-ray absorptiometry (DXA) and expressed in g. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  19. Change From Baseline to Week 26 in Estimated Visceral Adipose Tissue Mass Assessed by DXA

    Visceral adipose tissue mass will be estimated by whole-body dual-energy X-ray absorptiometry (DXA) and expressed in g. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  20. Change From Baseline to Week 26 in Relative Skeletal Muscle Index (RSMI) Assessed by DXA

    Relative skeletal muscle index (RSMI), calculated as appendicular lean mass divided by height squared, will be measured by whole-body dual-energy X-ray absorptiometry (DXA) and expressed in kg/m^2. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  21. Change From Baseline to Week 26 in Body Weight

    Body weight will be measured using a weighing scale and expressed in kilograms. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  22. Change From Baseline to Week 26 in Waist Circumference

    Waist circumference will be measured using a tape measure and expressed in centimeters. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  23. Change From Baseline to Week 26 in Waist-to-Hip Ratio

    Waist and hip circumferences will be measured using a standardized tape measure following WHO measurement protocols. The waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference, using the same units for both measurements. The ratio is unitless. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  24. Change From Baseline to Week 26 in Waist-to-Height Ratio

    Waist circumference and height will be measured following WHO measurement protocols. The waist-to-height ratio will be calculated by dividing waist circumference by height, using the same units for both measurements. The ratio is unitless. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  25. Change From Baseline to Week 26 in Whole-Blood Nicotinamide Mononucleotide (NMN) Concentration

    Nicotinamide mononucleotide (NMN) concentration will be measured in whole blood and expressed in nmol/L. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  26. Change From Baseline to Week 26 in Whole-Blood Nicotinamide Adenine Dinucleotide (NAD+) Concentration

    The concentration of oxidized nicotinamide adenine dinucleotide (NAD+) will be measured in whole blood and expressed in micromol/L. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  27. Change From Baseline to Week 26 in Relative Telomere Length in Peripheral Blood Cells

    Relative telomere length in peripheral blood cells will be measured by quantitative real-time polymerase chain reaction (qPCR) and reported as a unitless value. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  28. Change From Baseline to Week 26 in Peak Oxygen Uptake (Peak VO2)

    Peak oxygen uptake will be measured during cardiopulmonary exercise testing and expressed in mL/min. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

  29. Change From Baseline to Week 26 in Oxygen Uptake at the Anaerobic Threshold (VO2-AT)

    Oxygen uptake at the anaerobic threshold will be measured during cardiopulmonary exercise testing and expressed in mL/min. Change from baseline will be calculated as the Week 26 value minus the baseline value.

    Measured: Baseline and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start5 Jun 2025
  3. Primary completion18 Oct 2026
  4. Study completion18 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06907329
Sponsor's protocol ID
XHEC-C-2024-165-4
Status last verified
Oct 2026
First submitted
19 Mar 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NMN in people with Immunosenescence and Overweight, run by Qing Su 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 3 inclusion and 15 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: finished, as of the sponsor's last update on 3 Nov 2026. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 26 in the Percentage of CD3+CD8+CD27-CD28- T Cells Among Total CD3+CD8+ T Cells (time frame: Baseline and Week 26). 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 3 Nov 2026.

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