UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048950 |
|---|---|
| Receipt number | R000055757 |
| Scientific Title | Examination of changes in gut microbiota and host parameters after intake of food X and food Y |
| Date of disclosure of the study information | 2022/09/16 |
| Last modified on | 2023/03/20 09:42:45 |
* 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
Examination of changes in gut microbiota and host parameters after intake of food X and food Y
Acronym
Examination of changes in gut microbiota and host parameters after intake of food X and food Y
Scientific Title
Examination of changes in gut microbiota and host parameters after intake of food X and food Y
Scientific Title:Acronym
Examination of changes in gut microbiota and host parameters after intake of food X and food Y
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of food X and food Y on intestinal microbiota and metabolism of gut bacteria and the host
Basic objectives2
Others
Basic objectives -Others
To verify the effect of intestinal bacterial species Z on the response of intestinal microbiota and its metabolism to the ingestion of food X and food Y
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota
Fecal organic acids
Key secondary outcomes
Blood organic acids
Amount of food X discharged in stool
Bowel habit
Body weight
Energy expenditure
Carbohydrate and lipid metabolism
Blood pressure
Immunological parameters
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
After the 1-week observation period, participants will consume food X for 1 week, food Y for 1 week, and both food X and Y for 3 weeks. The day before the blood collection day, which will be set 5 times in total during the above periods, the participants well consume the designated meal.
During the above periods, all participants are to avoid binge eating, binge drinking, and consumption of foods that contain food X and similar ingredients.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Screening entry criteria; Adults who have a bowel movement almost every day.
Selection criteria at screening; Eight subjects each with and without endogenous intestinal bacterial species Z will be randomly selected to participate in subsequent interventions. Subjects who are suspected of being infected with COVID-19 during the subject selection period will be excluded from the selection. Subjects who have taken antibiotics during the selection period will also be excluded, as long as the planned number of subjects is satisfied.
Key exclusion criteria
Those who are pregnant or possibly pregnant.
Those who are unable to consume the test food due to allergy or other reasons.
Those who have taken antibiotics within 1 week prior to the stool sample collection for subject screening.
Those with symptoms of suspected COVID-19 infection.
Those who have ingested food Y in the past.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sato |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi, Tokyo 186-8650 Japan
TEL
042-577-8960
tadashi-sato@yakult.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Nagara |
Organization
Yakult Central Institute
Division name
Basic Research Department
Zip code
186-8650
Address
5-11 Izumi, Kunitachi, Tokyo 186-8650 Japan
TEL
042-577-8960
Homepage URL
yusuke-nagara@yakult.co.jp
Sponsor or person
Institute
Yakult Central Institute
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2022 | Year | 09 | Month | 16 | 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
23
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
| 2022 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055757
