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

NCT ID: NCT06907329

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Immunosenescence Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NMN Arm

NMN tablets (1000mg/tablet) , 1 tablet daily before breakfast

Group Type EXPERIMENTAL

NMN

Intervention Type DIETARY_SUPPLEMENT

NMN SR tablets(1000mg/tablets) , 1 tablet daily before breakfast

Placebo Arm

Matching Placebo (tablets) once daily before breakfast

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Matching Placebo (tablets) once daily before breakfast

Interventions

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NMN

NMN SR tablets(1000mg/tablets) , 1 tablet daily before breakfast

Intervention Type DIETARY_SUPPLEMENT

Placebo

Matching Placebo (tablets) once daily before breakfast

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qing Su

OTHER

Sponsor Role lead

Responsible Party

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Qing Su

Director, Dept of Endocrinology,Xinhua Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Su

Role: CONTACT

008613651611560

Facility Contacts

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QING SU

Role: primary

13651611560

Other Identifiers

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XHEC-C-2024-165-4

Identifier Type: -

Identifier Source: org_study_id

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