Actively Recruiting

Phase Not Applicable
Age: 50Years - 70Years
All Genders
ID06907329

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

Led by Qing Su · Updated on 2025-07-08

126

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of nicotinamide mononucleotide (NMN) supplementation on immunosenescence and metabolism in middle-aged and elderly people with metabolic disorders. This randomized, placebo-controlled clinical trial aims to provide new insights into improving immune system aging and potentially preventing glucose and lipid metabolic diseases. The study focuses on adults aged 50 to 70 years who have overweight or obesity and metabolic-related conditions such as fatty liver disease, pre-diabetes, or type 2 diabetes without glucose-lowering therapy. Participants will receive either NMN sustained-release tablets (1000 mg) or a matching placebo, taken once daily before breakfast for 26 weeks. Investigator visits will occur at months 1, 3, and 6 during the treatment period. The study includes a placebo group for comparison to assess the effects of NMN on immune cell markers and metabolic health. Throughout the study, participants will undergo evaluations including blood tests, body composition analysis, and cardiorespiratory fitness assessments. The primary measure is the percentage of certain immune cells (CD3+CD8+CD27-CD28- T cells) among total CD3+CD8+ T cells after 26 weeks. Secondary measures include glucose levels, pancreatic beta-cell function, telomere length, and safety labs such as liver and kidney function. Participant safety and treatment effects will be closely monitored during the entire study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 to 70 years with overweight or obesity (BMI 24 kg/m2 or higher)
  • At least one of the following: metabolism-related fatty liver disease diagnosed by ultrasound, pre-diabetes, or type 2 diabetes mellitus with HbA1c below 7% without glucose-lowering drug therapy
  • Willingness to participate, able to adhere to follow-up visits, and able to visit the hospital independently
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Diagnosis of tumors
  • Autoimmune diseases except Hashimoto's thyroiditis
  • Severe cardiovascular disease or heart failure
  • Systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg
  • Chronic obstructive pulmonary disease
  • Chronic active hepatitis or cirrhosis
  • Chronic kidney failure
  • History of stroke
  • Severe blood disorders
  • Infectious diseases
  • Mental illness
  • Any other conditions that may affect study results as judged by investigators
  • Use of NMN or other anti-aging agents within the past six months
  • Premenopausal women
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than three times the normal upper limit

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 26 weeks

Participants take NMN sustained-release tablets or placebo once daily before breakfast, and attend investigator visits to assess efficacy and safety.

3 visits (in-person) at months 1, 3, and 6

Trial Site Locations

Total: 1 location

1

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

Shanghai, China

Actively Recruiting

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Research Team

S

Su

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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