NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000025739

Registered date:20/01/2017

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

Basic Information

Public titleEffect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Scientific titleEffect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Recruitment statusComplete: follow-up complete
Health condition(s) or Problem(s) studiedHealthy volunteers
Study typeInterventional
Phase
Study design
Intervention(s)Subjects receive 100 mg/day of NMN for 24 weeks. Subjects receive 200 mg/day of NMN for 24 weeks.
Sample Size20
Date of first enrollment2017/03/01
Completion date31/03/2019
Countries of recruitmentJapan

Outcome(s)

Primary Outcomei) 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 OutcomeNumber and rate of adverse events.

Key inclusion & exclusion criteria

Age minimum50years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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 SponsorHiroshima University
Secondary
Source(s)Hakushindo Pharmaceutical Co.,Ltd

Secondary Identifiers

Secondary ID

Contact

public contact
Name Fumiko Higashikawa
Address Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN Japan
Telephone 082-257-1533
E-mail fumiko@hiroshima-u.ac.jp
Affiliation Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine
scientific contact
Name Fumiko Higashikawa
Address Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN Japan
Telephone 082-257-1533
E-mail fumiko@hiroshima-u.ac.jp
Affiliation Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine

Ethics Reviews

StatusYES
Approval Date17/01/2017
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Summary Results

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Baseline Characteristics
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URL link to protocol file(s) with version and date

IPD sharing statement

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