UMIN ID: UMIN000021309
Registered date:03/03/2016
Assessment of the safety of nicotinamide mononucleotide (NMN) in healthy subjects; phase I study. The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | healthy subjects |
| Date of first enrollment | 2016/03/09 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | the single intake of NMN. |
Outcome(s)
| Primary Outcome | the safety of NMN (physical and laboratory examinations). |
|---|---|
| Secondary Outcome | the kinetics of NMN. |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | 60years-old |
| Gender | Male |
| Include criteria | |
| Exclude criteria | 1 the subjects with a previous history of diseases. 2 the subjects with malignant neoplasms. 3 the subjects with serious infections. 4 the subjects with psychiatric disorders. 5 the subjects with ophthalmic disorder. 6 the subjects with allergic disorders. 7 the subjects who are regarded as inadequate by the investigator. |
Related Information
| Primary Sponsor | Keio University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Keio University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Junichiro Irie |
| Address | 35 Shinanomachi, Shinjuku, Tokyo, JAPAN Japan 1608582 |
| Telephone | 03-5363-3797 |
| j-irie@z8.keio.jp | |
| Affiliation | Keio University School of Medicine Division of Endocrinology, Metabolism and Nephrology |
| scientific contact | |
| Name | Hiroshi Itoh |
| Address | 35 Shinanomachi, Shinjuku, Tokyo, JAPAN Japan |
| Telephone | 03-5363-3797 |
| hiito@z8.keio.jp | |
| Affiliation | Keio University School of Medicine Division of Endocrinology, Metabolism and Nephrology |