UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047042 |
|---|---|
| Receipt number | R000053474 |
| Scientific Title | Effect of oral ingestion of NMN on blood NAD derivatives concentration |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/03/10 18:46:17 |
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Basic information
Public title
Examination of changes in blood NAD and NMN concentration by oral intake of NMN
Acronym
Examination of changes in blood NAD and NMN concentration
Scientific Title
Effect of oral ingestion of NMN on blood NAD derivatives concentration
Scientific Title:Acronym
Effect on blood NAD derivatives concentration
Region
| Japan |
Condition
Condition
Men and women aged between 20 and 60 without critical diseases such as diabetes mellitus.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of increasing blood NAD concentration by NMN intake in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood NAD level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
After collecting the blood of volunteers, they ingest 250mg of NMN supplement a day for 12 weeks and collect blood every 4 weeks. Changes in blood NAD levels before and after ingestion of NMN are measured over time. Blood is collected 4 weeks after the end of ingestion, and the amount of NAD in the blood is measured.
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
| 20 | years-old | < |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy male and female volunteers
2. Between 20 and 70 years of age
3. Be able to provide written informed consent
Key exclusion criteria
With a critical disease such as diabetes mellitus
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Yamane |
Organization
ByU-Analytica Inc.
Division name
Division of Research and Development
Zip code
565-0871
Address
2-1 Yamadaoka, Suita, Osaka
TEL
06-6879-4177
yamane@byuanalytica.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yamane |
Organization
ByU-Analytica Inc.
Division name
Division of Research and Development
Zip code
565-0871
Address
2-1 Yamadaoka, Suita, Osaka
TEL
06-6879-4177
Homepage URL
yamane@byuanalytica.com
Sponsor or person
Institute
ByU-Analytica Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ByU-Analytica Ethics Review Board
Address
1-8-3 Nakanoshima, Kita-ku, Osaka-shi, Osaka
Tel
06-7777-1415
rinri@byuanalytica.com
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
| 2022 | Year | 03 | Month | 01 | 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
11
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
| 2022 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053474
