UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045205 |
|---|---|
| Receipt number | R000051646 |
| Scientific Title | Comprehensive evaluation of changes in blood dynamics due to anti-aging supplement intake |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2023/02/20 13:10:10 |
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Basic information
Public title
Clinical trials with anti-aging supplements
Acronym
Clinical trials with anti-aging supplements
Scientific Title
Comprehensive evaluation of changes in blood dynamics due to anti-aging supplement intake
Scientific Title:Acronym
Clinical trials with anti-aging supplements
Region
| Japan |
Condition
Condition
not application
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
By taking anti-aging supplements, the amount of changes in related substances in the blood is confirmed, and the quantitative analysis of the sirtuin gene is performed. The purpose is to widely confirm what kind of anti-aging action is seen.
Basic objectives2
Others
Basic objectives -Others
Anti-aging supplements are used to measure hormone testing, liver function, lipids, blood calculations, vascular testing (ABI/PWV), bone density, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NMN-related substance testing in the blood (NMN, NAD, NAM)
Sirtuin genetic testing
Key secondary outcomes
Hormone testing, liver function, lipids, blood count, va-scular testing (ABI/PWV), bone density,AGEs,8-OHdG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
250mg/day Anti-aging ingredients for 12 weeks
Interventions/Control_2
Placebo for 12weeks
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women over 40 years old at the time of obtaining consent to participate in the examination
Key exclusion criteria
1) Suffering from or history of serious hepatic disorder, renal, cardiac, pulmonary, or gastrointestinal (including gastrectomy) disease, diabetes, food allergy, or other serious disease
2) Taking medications which are related to affectung outcomes in this study.
3)Participating other clinical trials
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Masakatsu |
| Middle name | |
| Last name | Kageyama |
Organization
DHC Corparation
Division name
Supplements Department
Zip code
2610025
Address
Food Laboratory
TEL
043-275-4811
mkageyam@dhc.co.jp
Public contact
Name of contact person
| 1st name | Sachi |
| Middle name | |
| Last name | Uehata |
Organization
Supplements Department
Division name
Supplements Laboratory
Zip code
2610025
Address
2-42 Hamada,Mihanaku,Chiba 261-0025
TEL
043-275-4811
Homepage URL
suehata@dhc.co.jp
Sponsor or person
Institute
DHC Corporation
Supplements Department
Institute
Department
Personal name
Funding Source
Organization
DHC Corporation
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
DHC Ethics Committee
Address
2-42 Hamada,Mihanaku,Chiba 261-0025
Tel
043-275-4811
knaito@dhc.co.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
病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-023-29787-3
Number of participants that the trial has enrolled
36
Results
Takeshi Katayoshi, Sachi Uehata, Noe Nakashima, Takahisa Nakajo, Natsuko Kitajima, Masakatsu Kageyama, Kentaro Tsuji-Naito. Nicotinamide adenine dinucleotide metabolism and arterial stiffness after long-term nicotinamide mononucleotide supplementation: a randomized, double-blind, placebo-controlled trial. Scientific Reports. (2023) 13:2786
Results date posted
| 2023 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 16 | Day |
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2021 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051646
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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