UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023465
Receipt No. R000026675
Scientific Title Exploratory research for metabolites in human blood and urine samples after food intake.
Date of disclosure of the study information 2016/08/08
Last modified on 2018/10/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exploratory research for metabolites in human blood and urine samples after food intake.
Acronym Exploratory research for metabolites in human blood and urine samples after food intake.
Scientific Title Exploratory research for metabolites in human blood and urine samples after food intake.
Scientific Title:Acronym Exploratory research for metabolites in human blood and urine samples after food intake.
Region
Japan

Condition
Condition healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the change of metabolites of blood and urine samples in human after meal intake.
Basic objectives2 Others
Basic objectives -Others metabomics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes metabolites
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 test meal
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 healthy person. no commonly used drugs. no abdominal operation history.
Key exclusion criteria 1. current treatment
2. patients with CVD, liver damage, renal impairment, respiratory disease, endocrine disorders, metabolic disturbance
3. chest pain, faint
4. possibility: allergy from test meal
5. Blood donation (<1 month over 200 ml, <
month over 400ml)
6. inadequate enrollment judged from director
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihito Fujita
Organization Graduate School of Medicine, Kyoto University
Division name Department of Diabetes, Endocrinology and Nutrition
Zip code
Address 54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL 0757513560
Email yfujita9@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihito Fujita
Organization Graduate School of Medicine, Kyoto University
Division name Department of Diabetes, Endocrinology and Nutrition
Zip code
Address 54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL 0757513560
Homepage URL
Email yfujita9@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 08 Month 08 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 Day
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
2016 Year 08 Month 03 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026675

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.