UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049673 |
|---|---|
| Receipt number | R000056576 |
| Scientific Title | Functional exploratory research of foods |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/01/04 18:23:51 |
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Basic information
Public title
Functional exploratory research of foods
Acronym
Functional exploratory research of foods
Scientific Title
Functional exploratory research of foods
Scientific Title:Acronym
Functional exploratory research of foods
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ingest test foods for 4 weeks in adult men and women and examine the effects on gut microbiome and quality of life. Group comparisons will be made between the intake group or the non-intake group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
gut microbiome
Key secondary outcomes
Quality of life Questionnaire
1) Izumo Scale
2) OSA sleep inventory
3) POMS2 Japanese edition
4) The Brief Job Stress Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake Test foods for 4weeks
Interventions/Control_2
non-intake
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 18 and 60 at the time consent is obtained
2. Full-time employees who are employed by Meiji Co., Ltd. and work at the Meiji Innovation Center
3. Those who have received sufficient explanation about the purpose and contents of this study, have the ability to consent, fully volunteered with voluntary intention, agreed to participate
Key exclusion criteria
1. Those who belongs to clinical Study group or microbiome group
2. Those who participated in other clinical trials and monitoring examinations during the month before screening, or who plan to participate in other clinical trials after this clinical trial consent
3. Those who have some type of chronic illness and are undergoing drug treatment
4. Those who previous appendectomy or lower gastrointestinal surgery in the past
5. Those who have undergone a barium stomach X-ray or a enteroscopy or a colonoscopy and used laxatives during the month prior to the screening period, or bowel cleansing, or who are scheduled to undergo such an examination during this study.
6. Those who are allergic to dairy ingredients
7. Those who aware of lactose intolerance
8. Those who have taken, ingested, or used any pharmaceutical, quasi-drug, or herbal medicine that may affect the study at least once a week during the 3 months prior to the screening, or is scheduled to take, ingest, or use such pharmaceutical, quasi-drug, or herbal medicine at least once during the study
9. Those who plan to take or use supplements or health foods that may affect the study at least once during the study
10. Those who have regularly consumed food containing the test ingredient within 1 month prior to the screening period
11. Those who regularly consume large amount of alcohol
12. Those who pregnant or those who plan or wish to become pregnant during the study
13. Those who is breastfeeding
14. Those who plan to travel abroad, travel for more than one week, or go on a business trip during the period from one week before the screening period to the end of the study
15. Those whose stool bifidobacteria counts are below the detection limit in the screening
16. Subjects judged as unsuitable for the study by the principal investigator or research physician for other reasons
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Makino |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji-shi, Tokyo
TEL
042-632-5838
seiya.makino@meiji.com
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Makino |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji-shi, Tokyo
TEL
042-632-5838
Homepage URL
seiya.makino@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
| 2023 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 27 | 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 | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056576
