UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041232
Receipt number 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 2023/01/29 19:01:46

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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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

5

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

No longer recruiting

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

2023 Year 01 Month 29 Day



Link to view the page

Value
https://center6.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