Assessment of the safety of long-term nicotinamide mononucleotide (NMN) in healthy subjects; phase II study. The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims.

UMIN ID: UMIN000030609

Registered date:29/12/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy subjects
• Date of first enrollment: 2019/08/06
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): long-term (8 weeks) intake of NMN

Outcome(s)

• Primary Outcome: the safety of long-term (8weeks) NMN (physical and laboratory examinations).
• Secondary Outcome: 1.the kinetics of NMN and metabolites of nicotinamide. 2.the effect of daily NMN admnistration on glucose metabolism

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 60years-old
• Gender: Male
• 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. 8 the subjects who have obvious abnormality in the screening test

Related Information

• Primary Sponsor: Keio University School of Medicine
• Source(s) of Monetary Support: ORIENTAL YEAST CO.,LTD