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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041232
Receipt No. R000047082
Scientific Title Analysis of blood NAD+ pathway metabolites in healthy subjects
Date of disclosure of the study information 2020/07/28
Last modified on 2020/07/28

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Basic information
Public title Analysis of blood NAD+ pathway metabolites in healthy subjects
Acronym N/A
Scientific Title Analysis of blood NAD+ pathway metabolites in healthy subjects
Scientific Title:Acronym N/A
Region
Japan

Condition
Condition N/A
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the difference in blood components between 9 o'clock and 21 o'clock in healthy subjects using the metabolome analysis by mass spectrometry.
Basic objectives2 Others
Basic objectives -Others Exploratory research without drug administration
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Quantification of blood NAD+ value and comparison of blood concentration between morning and night
Key secondary outcomes Comparison of blood concentrations of metabolites detected by mass spectrometry between morning and evening

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 Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 Meal control
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Healthy adults
*Health means a person who has not taken regular medication and has not been hospitalized.
2. Those who agree to sign the informed consent form
Key exclusion criteria 1. Those who take supplements containing vitamin B3 and wish to continue during the trial.
2. Those who are potentially pregnant.
3. Those who are under lactation.
4. Those who are under treatment.
5. Those judged by doctors or researchers to be inappropriate to participation in research.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomohito
Middle name
Last name Sato
Organization Hamamatsu University School of Medicine
Division name Department of Cellular and Molecular Anatomy
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL 053-435-2086
Email 07485496@hama-med.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Ito
Organization RIKEN
Division name Center for Sustainable Resource Science
Zip code 351-0198
Address 2-1 Hirosawa, Wako, Saitama, Japan
TEL 048-467-9518
Homepage URL
Email takashi.ito.cj@riken.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel 053-435-2111
Email rinri@hama-med.ac.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
2020 Year 07 Month 28 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 22 Day
Date of IRB
2020 Year 07 Month 22 Day
Anticipated trial start date
2020 Year 07 Month 28 Day
Last follow-up date
2025 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
2020 Year 07 Month 28 Day
Last modified on
2020 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047082

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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