UMIN-CTR Clinical Trial

Basic information
Public title	Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Acronym	Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Scientific Title	Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Scientific Title:Acronym	Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of long-term oral administration of NMN on various hormonal levels as an exploratory trial
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

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) *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.
Key secondary outcomes	Number and rate of adverse events.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy
Key exclusion 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
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Email	fumiko@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Homepage URL
Email	fumiko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hakushindo Pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 11 Day
Date of IRB	2017 Year 01 Month 17 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 19 Day
Last modified on	2019 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029616

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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