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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000025739 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Healthy volunteers | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |