UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025739 |
|---|---|
| Receipt number | R000029616 |
| Scientific Title | Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2019/04/18 09:45:51 |
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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
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
fumiko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029616
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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