Sustained-release NMN tablets for immune aging and metabolism in middle-aged and older adults with metabolic disorders

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

This 26-week treatment will test whether a daily sustained-release NMN tablet can slow immune aging and improve metabolism in people aged 50–70 with overweight and metabolic conditions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 50 Years to 70 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06907329 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo-controlled, parallel-group trial enrolling adults 50–70 years with BMI ≥24 kg/m2 and at least one metabolic condition (metabolic-associated fatty liver by ultrasound, prediabetes, or well-controlled type 2 diabetes not on glucose-lowering drugs). Participants will take one 1000 mg sustained-release NMN tablet or matching placebo each morning for 26 weeks with clinic visits at months 1, 3, and 6. The primary endpoint is the percentage of CD3+CD8+CD27-CD28- cells among CD3+CD8+ T cells as a marker of immunosenescence, with secondary measures including liver fat, body composition, β-cell function, telomere length, fasting glucose, HbA1c, and cardiorespiratory fitness. Safety monitoring includes routine blood and urine tests and liver and kidney function assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50–70 with overweight or obesity (BMI ≥24 kg/m2) who have metabolic-associated fatty liver disease, prediabetes, or type 2 diabetes with HbA1c <7% without glucose-lowering drug therapy and who can attend regular hospital visits.

Not a fit: Patients with active cancer, autoimmune disease (other than Hashimoto's), severe cardiovascular or pulmonary disease, uncontrolled hypertension, chronic liver or renal insufficiency, recent stroke, severe hematologic or infectious disease, mental illness, or other conditions judged by investigators are excluded and may not receive benefit.

Why it matters

Potential benefit: If successful, NMN SR could reduce markers of immune aging and improve glucose, lipid, and body-composition measures, potentially lowering risks associated with metabolic disorders.

How similar studies have performed: Preclinical studies and small human trials of NMN and other NAD+ precursors have shown metabolic and cellular-aging signals, but robust placebo-controlled evidence for reversing immunosenescence in older adults is still limited.

Eligibility criteria

Inclusion Criteria:

1. Age 50-70 years with overweight or obesity (BMI 24kg/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.

Exclusion Criteria:

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;
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 woman
15. ALT, AST values are more than three times higher than the upper limit of the normal reference range

Where this trial is running

Shanghai

• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Su

Conditions: Immunosenescence, Metabolism