UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023142 |
|---|---|
| Receipt number | R000026680 |
| Scientific Title | The effect of staple food (rice or bread) for intestinal flora in healthy people |
| Date of disclosure of the study information | 2016/07/13 |
| Last modified on | 2019/07/17 12:02:55 |
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Basic information
Public title
The effect of staple food (rice or bread) for intestinal flora in healthy people
Acronym
The effect of staple food for intestinal flora
Scientific Title
The effect of staple food (rice or bread) for intestinal flora in healthy people
Scientific Title:Acronym
The effect of staple food for intestinal flora
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of staple food for intestinal flora.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hydrogen in the breath by 1 week
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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, who has no commonly used drugs, who has not been pointed out an anomaly in the health diagnosis for past one year.
Key exclusion criteria
If the consent can not be obtained,
Who has underlying disease,
Who has commonly used drugs,
Who has food allergy,
Who used intestinal drugs or antibiotics during the study period,
Who had obvious poor health such as diarrhea or fever during the study period.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
Address
54, Kawaramachi, Shougoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3560
krikeda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
Address
54, Kawaramachi, Shougoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3560
Homepage URL
krikeda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries
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
| 2016 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/10/9/1323
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/10/9/1323
Number of participants that the trial has enrolled
10
Results
After the bread period, the abundance of fecal Bifidobacterium genus, fasting glucagon-like peptide 1, and breath hydrogen were significantly higher than those of after the rice period. Plasma SCFAs also tended to be higher after the bread period.
Results date posted
| 2019 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy subjects
Participant flow
a total of seven subjects
Adverse events
Nothing
Outcome measures
the abundance of fecal Bifidobacterium genus
fasting glucagon-like peptide 1
breath hydrogen
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026680
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/01/14 | 研究計画書米飯.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/01/14 | 説明.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/01/14 | 対応のあるt検定用採血結果.jmp |
Single case data URL
Value
https://center6.umin.ac.jp/ice/26680
