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

NCT06907329 | Recruiting DMC

• 1 other identifier: XHEC-C-2024-165-4
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunosenescence; Metabolism

Outcome Measures

Primary Outcomes (1)

• CD3+CD8+CD27-CD28- T cells as a percentage of CD3+CD8+ T cells, expressed in %, evaluated by flow cytometry

  26 weeks

Secondary Outcomes (19)

• 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

Study Arms (2)

NMN Arm

EXPERIMENTAL

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

Dietary Supplement: NMN

Placebo Arm

PLACEBO COMPARATOR

Matching Placebo (tablets) once daily before breakfast

Dietary Supplement: Placebo

Interventions

NMN DIETARY_SUPPLEMENT

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

NMN Arm

Placebo DIETARY_SUPPLEMENT

Matching Placebo (tablets) once daily before breakfast

Placebo Arm

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-70 years with overweight or obesity (BMI 24kg/m2);
• 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;
• 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.

You may not qualify if:

• Patients with tumours;
• Patients with autoimmune diseases (excluding Hashimoto's thyroiditis);
• Severe cardiovascular disease or cardiac insufficiency;
• Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg;
• Chronic obstructive pulmonary disease;
• Chronic active hepatitis or cirrhosis;
• Chronic renal insufficiency;
• Stroke patients
• Severe haematological diseases;
• Infectious diseases;
• Mental illness;
• Other conditions that, in the opinion of the investigator, may affect the results of the study;
• Those who have used NMN or other anti-aging agents within six months.
• Premenopausal woman
• ALT, AST values are more than three times higher than the upper limit of the normal reference range

Sponsors & Collaborators

• Qing Su: lead

Study Sites (1)

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

Shanghai, China

RECRUITING

Central Study Contacts

Su

CONTACT

008613651611560; suqing139@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Dept of Endocrinology,Xinhua Hospital

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 2, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)