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Many of us will have seen the npj Aging and Mechanisms of Disease news story "The first human clinical study for NMN has started in Japan" that accompanied the Elysium Basis trial. It linked the entry in the Japanese clinical trial registry. Here are the English-language registry entries for current and upcoming NMN trials there:
Official scientific title of the study 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.
Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021309
Date of disclosure of the study information 2016/03/03
Last modified on 2016/08/04
Blinding Open -no one is blinded
Control Uncontrolled
Age-lower limit 40 years-old <=
Age-upper limit 60 years-old >=
Gender Male
Key inclusion criteria the healthy subjects who agree to the study.
Name of lead principal investigator Hiroshi Itoh
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Recruitment status No longer recruiting
Publication of results Unpublished
Funding Source
Organization Keio University
Official scientific title of the study 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.
Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030609
Date of disclosure of the study information 2017/12/29
Last modified on 2018/01/05
Primary outcomes the safety of long-term (8weeks) NMN (physical and laboratory examinations).
Key secondary outcomes the kinetics of NMN and metabolites of nicotinamide.
Study type Interventional
Study design
Basic design Single arm
Randomization Non-randomized
Blinding Open -no one is blinded
Control Uncontrolled
Age-lower limit 40 years-old <=
Age-upper limit 60 years-old >=
Gender Male
Key inclusion criteria the healthy subjects who agree to the study.
Name of lead principal investigator Hiroshi Itoh
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Funding Source
Organization ORIENTAL YEAST CO.,LTD
Official scientific title of the study Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025739
Date of disclosure of the study information 2017/01/20
Last modified on 2017/07/21
Assessment
Primary outcomes
i) Serum or plasma concentration of the following parameters at baseline, weeks 4, 8, 12, 18, and 24.*Thyroid-stimulating hormone (TSH)
ii) Mitochondria activity in leucocyte at baseline and week 24.
*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
iii) Sirt1 and Sirt2 gene expressions in leucocyte at baseline and week 24.
Key secondary outcomes Number and rate of adverse events.
Study type Interventional
Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Interventions/Control_1 Subjects receive 100 mg/day of NMN for 24 weeks.
Interventions/Control_2 Subjects receive 200 mg/day of NMN for 24 weeks.
Age-lower limit 50 years-old <=
Age-upper limit 70 years-old >=
Gender Male and Female
Key inclusion criteria Healthy
Name of lead principal investigator Fumiko Higashikawa
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Project Research Center for Clinical Trial and Preventive Medicine
Funding Source
Organization Hakushindo Pharmaceutical Co.,Ltd
