Parallel-group comparative study to evaluate the effect of high-dose nicotinamide mononucleotide (NMN) on aging

JRCT ID: jRCTs031220373

Registered date:11/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Older adults who do not take medicine
• Date of first enrollment: 17/10/2022
• Target sample size: 62
• Study type: Interventional

Intervention(s)

Participants will be randomized in 2 groups:
NMN 1,250 mg (5 tablets of 250 mg) orally, once a day, 24 weeks
Placebo (5 tablets) orally, once a day, 24 weeks

Outcome(s)

• Primary Outcome: Change from baseline in hearing ability after 24 weeks of treatment

Secondary Outcome

1) Change from baseline in the following items related to aging after 24 weeks of treatment.
1.Physical function
2. Blood tests
3. Biomarkers
4. DNA methylation age
5. Skin condition
6. Exercise tolerance assessed by the 6 minute walk test
7. Gut and oral microbiota
8. Number of mitochondria
9. Quality of Life
2) Correlation between blood NAD level and these items.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Non-smoker
2. Aged 65 years old or older at the time of informed consent is taken
3. Male or female
4. Able to attend all scheduled visits
5. Able and willing to give written informed consent

Exclude criteria

1. Taking health food
2. With severe hearing loss or wearing a hearing aid in daily life
3. Taking more than 1 hour daily exercise for more than 6 months
4. With a pacemaker
5. Taking medicine, including Chinese medicine
6. Having history of treatment for cancer, heart failure and myocardial infarction
7. With atrial fibrillation, arrhythmia, liver failure, renal failure, cerebrovascular disease, rheumatoid arthritis and other chronic diseases except diabetes, dyslipidemia and hypertension
8. Suspected of having viral hepatitis, HIV or syphilis
9. With drug allergy or with food allergy to health food related to this study
10. Participated in other clinical trials within 3 months
11. Judged as ineligible by clinical investigators

Related Information

• Primary Sponsor: Yamauchi Toshimasa
• Secondary Sponsor: MIRAILAB BIOSCIENCE Inc