UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029569 |
|---|---|
| Receipt number | R000032269 |
| Scientific Title | Development of biomarkers of macronutrient intake by integrated analysis of metabolome data between human samples and components derived from foods. |
| Date of disclosure of the study information | 2017/10/18 |
| Last modified on | 2018/10/17 09:30:56 |
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Basic information
Public title
Development of biomarkers of macronutrient intake by integrated analysis of metabolome data between human samples and components derived from foods.
Acronym
Development of biomarkers of macronutrient intake by integrated analysis of metabolome data between human samples and components derived from foods
Scientific Title
Development of biomarkers of macronutrient intake by integrated analysis of metabolome data between human samples and components derived from foods.
Scientific Title:Acronym
Development of biomarkers of macronutrient intake by integrated analysis of metabolome data between human samples and components derived from foods
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 rice or bread 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
rice, bread
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
| 65 | 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
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
yfujita9@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
| 2017 | Year | 10 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 23 | 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
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032269
