UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049455 |
|---|---|
| Receipt number | R000056229 |
| Scientific Title | Evaluation test for improvement of intestinal environment by baby food containing a lot of vegetables |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/11/14 07:48:00 |
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Basic information
Public title
Evaluation test for improvement of intestinal environment by baby food containing a lot of vegetables
Acronym
Evaluation test for improvement of intestinal environment by baby food containing a lot of vegetables
Scientific Title
Evaluation test for improvement of intestinal environment by baby food containing a lot of vegetables
Scientific Title:Acronym
Evaluation test for improvement of intestinal environment by baby food containing a lot of vegetables
Region
| Japan |
Condition
Condition
healthy infants
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate changes in body condition and intestinal microflora as a result of consumption of vegetable-rich baby food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition by questionnaire Changes before and after(4 weeks intake)
Key secondary outcomes
Before and after comparison of intestinal microflora(4 weeks intake)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume a selection of 10 test foods at least twice a day for 4 weeks
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
| 9 | months-old | <= |
Age-upper limit
| 12 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. infants between 9 and 12 months of age
2. infants prone to constipation
3. infants who have obtained written consent from their parents or guardians
4. Healthy infants who are not receiving any medical treatment or medication
5. Infants who are able to maintain a regular daily routine during the study period.
Key exclusion criteria
1. Infants with possible food allergy to the test food
2. Infants who are deemed ineligible by the investigator to participate in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Kimura |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi,Tokyo,Japan
TEL
03-5384-7758
mamoru_kimura@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Kimura |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi,Tokyo,Japan
TEL
03-5384-7758
Homepage URL
mamoru_kimura@kewpie.co.jp
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno Asagao Clinic Ethics Review Board
Address
Kairaku Building 6F,2-7-5, Ueno, Taito-ku,Tokyo,Japan
Tel
03-6801-8480
t.tamura@tes-h.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
| 2023 | Year | 01 | 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
19
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056229
