Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health

UMIN ID: UMIN000025739

Registered date:20/01/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 2017/03/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Subjects receive 100 mg/day of NMN for 24 weeks.
Subjects receive 200 mg/day of NMN for 24 weeks.

Outcome(s)

• Primary Outcome: i) Serum or plasma concentration of the following parameters at baseline, weeks 4, 8, 12, 18, and 24. *Thyroid-stimulating hormone (TSH) *Free triiodothyronine (Free T3) *Free thyroxine (Free T4) *Growth hormone (GH) *Prolactin *Parathyroid hormone (PTH) *Dehydroepiandrosterone sulfate (DHEA-S) *Estradiol (E2) *Testosterone *Calcitonin *Adrenocorticotropic hormone (ACTH) *Arginine vasopressin (AVP) *Cortisol *Aldosterone *Ghrelin *Inhibin *Melatonin ii) Mitochondria activity in leucocyte at baseline and week 24. iii) Sirt1 and Sirt2 gene expressions in leucocyte at baseline and week 24.
• Secondary Outcome: Number and rate of adverse events.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) Taking medicines for chronic disease 2) Taking functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) History of hypersensitivity caused by NMN 5) In pregnancy or nursing a child 6) Judged as ineligible by clinical investigators

Related Information

• Primary Sponsor: Hiroshima University
• Source(s) of Monetary Support: Hakushindo Pharmaceutical Co.,Ltd