![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000041677 |
Receipt No. | R000047573 |
Scientific Title | Exploratory study on the health promotion effect of intake NMN-containing supplement |
Date of disclosure of the study information | 2020/09/04 |
Last modified on | 2021/02/10 |
Basic information | ||
Public title | Exploratory study on the health promotion effect of intake NMN-containing supplement | |
Acronym | Exploratory study on the health promotion effect of intake NMN-containing supplement | |
Scientific Title | Exploratory study on the health promotion effect of intake NMN-containing supplement | |
Scientific Title:Acronym | Exploratory study on the health promotion effect of intake NMN-containing supplement | |
Region |
|
Condition | ||
Condition | Healthy Adults | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluate the health promotion effect on Males (40 to 64 years old) by intake NMN-containing supplement for four weeks |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | - Oxidative stress level (urinary 8-OHdG, urinary creatinine)
-8-OHdG in semen at the beginning of or after the intake for four weeks. |
Key secondary outcomes | - quantity of Semen
- count of Sperm - concentration of Sperm - testosterone in semen - creatine in semen - zinc in semen - spermine in semen - Questionnaire (Life style) at the beginning of or after the intake for four weeks. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
|
|
Interventions/Control_1 | Take 1 capsule of NMN-containing supplement at breakfast daily for four weeks. | |
Interventions/Control_2 | ||
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male | |||
Key inclusion criteria | 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Males who are 40 years old or more and under 65 years old 3.Persons who have sleep stress (do not feel well asleep) and physical fatigue by work or workout. 4.Persons with high urinary 8-OHdG, 8-OHdG in semen at screening |
|||
Key exclusion criteria | 1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food 3.Persons who usually take test food 4.Persons who usually take medicine, specified health food, healthy food and supplements that may have anti oxidative effect 5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 6.Persons who were judged as inappropriate for subjects by the principal investigator |
|||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Healthcare Systems Co., Ltd. | ||||||
Division name | Research and Development Department | ||||||
Zip code | 105-0004 | ||||||
Address | Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN | ||||||
TEL | 03-6809-2722 | ||||||
ishikawa@hc-sys.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Healthcare Systems Co., Ltd. | ||||||
Division name | Sales Planning Department | ||||||
Zip code | 105-0004 | ||||||
Address | Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN | ||||||
TEL | 03-6809-2722 | ||||||
Homepage URL | |||||||
info@karadacheck.com |
Sponsor | |
Institute | Healthcare Systems Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | TEIJIN LIMITED |
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 | The Ethics Committee of Healthcare Systems Co., Ltd. |
Address | Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN |
Tel | 03-6809-2722 |
soumu@hc-sys.jp |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 30 |
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047573 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |