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

Not Applicable

Not yet recruiting

• Conditions: Immunosenescence; Metabolism

• Registration Number: NCT06907329
• Lead Sponsor: Qing Su

Brief Summary

The ageing of our country is increasing and the ageing of the population has led to a significant increase in aging related diseases. During the aging process of the organism, cellular senescence can occur in all systems of the body, of which the senescence of the immune system is called immunosenescence. Some studies have shown that metabolic disorders can also trigger aging. This study investigated the effect of nicotinamide mononucleotide (NMN) supplementation on immunosenescence in middle-aged and elderly people through a placebo-controlled long-range clinical trail, aiming to provide a new method to improve immunosenescence. The effects of NMN supplementation on glucose and lipid metabolic indexes, body composition and telomere length of peripheral blood cells are also investigated, which may open up new ideas for the prevention and treatment of glucose and lipid metabolic diseases.

Detailed Description

A randomised, placebo-controlled, parallel group study to assess the efficacy and safety of NMN in middle-aged and elderly people with immunosenescence. People aged 50-70 years will be included in the study. Participants will be given NMN SR tablets (1000mg/tablet) or placebo, 1 tablet daily before breakfast. The study treatment period lasts 26 weeks. Investigator visits will be conducted at months 1, 3 and 6. Percentage of CD3+CD8+CD27-CD28- cells to total CD3+CD8+ T cells will be used as the primary evaluation metrics for assessing efficacy.Liver fat content, body composition analysis, pancreatic β-cell function, telomere length, fasting blood glucose, glycosylated hemoglobin, and cardiorespiratory fitness will be used as secondary indicators for efficacy assessment. Physiological and biochemical parameters such as blood and urine routine, liver and kidney function will be used for safety assessment.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study Start: 2025-04-01
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Age 50-70 years with overweight or obesity (BMI 25kg/m2);
2. At least one of the following: metabolic disorder-associated fatty liver disease; pre-diabetes or type 2 diabetes mellitus with HbA1c <7% without hypoglycemic 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CD3+CD8+CD27-CD28- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry	26 weeks

Secondary Outcome Measures

Name	Time	Method
Body composition analysis, expressed in kg, %, and g/cm², evaluated by dual-energy X-ray absorptiometry	26 weeks
Determination of fasting blood glucose and OGTT 2-hour blood glucose, expressed in mmol/L, evaluated by glucose oxidase method	26 weeks
CD3+CD8+CD27- T cells as a percentage of total CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
CD3+CD8+CD28- T cells as a percentage of total CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
CD3+CD4+CD27- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
CD3+CD4+CD28- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
CD3+CD4+CD27-CD28- T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
CD3+CD8+CD45RA+CCR7- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
CD3+CD8+CD57+KLRG1+ T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
CD3+CD8+ T cells as a percentage of CD3+CD4+ T cells, expressed in %, evaluated by flow cytometry	26 weeks
Peripheral blood cell telomere length, expressed as a unitless value , evaluated by Quantitative Real-time polymerase chain reaction	26 weeks
Cardiorespiratory fitness related indicators, expressed in mL/kg/min, L/min, beats/min, and unitless ratios, evaluated by COSMED metabolic cart during cardiopulmonary exercise testing	26 weeks
Pancreatic β-cell function, expressed as a unitless value, evaluated by HOMA-β、HOMA-IR	26 weeks
Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)	26 weeks	Scale Range: 0 (excellent sleep quality) to 21 (severe sleep disturbance) Interpretation: Higher scores indicate worse sleep quality. Subscales: Subjective sleep quality, sleep latency, sleep duration, etc.
Weight, expressed in kilograms, evaluated by weighing scale	26 weeks
NMN, NAD+ levels in peripheral blood cells, evaluated by mass spectrometry	26 weeks
Quality of Life assessed by the 36-Item Short Form Health Survey (SF-36)	26 weeks	Scale Range: 0 (worst possible health) to 100 (best possible health) Interpretation: Higher scores indicate better health-related quality of life. Subscales: Physical functioning, mental health, social functioning, etc.
Waist circumference, expressed in centimeters, evaluated by tape measure	26 weeks
Glycosylated hemoglobin, expressed in mmol/mol, evaluated by HPLC	26 weeks
Waist-to-hip ratio, expressed as a unitless ratio, evaluated using a standardized tape measure following WHO measurement protocols.	26 weeks
Waist-to-height, expressed as a unitless ratio, evaluated using a standardized tape measure following WHO measurement protocols.	26 weeks