UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055657 |
|---|---|
| Receipt number | R000063369 |
| Scientific Title | Next Generation Weaning Food Recipe Development by Multi-professionals (Toward the revision of the guide for breastfeeding and weaning) |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/02/14 21:52:41 |
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Basic information
Public title
Feasibility of next-generation weaning nuts recipes by multidisciplinary (Toward the revision of the guide for breastfeeding and weaning)
Acronym
Feasibility of nut-weaning recipes
Scientific Title
Next Generation Weaning Food Recipe Development by Multi-professionals (Toward the revision of the guide for breastfeeding and weaning)
Scientific Title:Acronym
Next Generation Weaning Food Recipe Development by Multi-professionals
Region
| Japan |
Condition
Condition
Infants who will be 5 months to 1.5 years old at the start of this study
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop recipes for nuts that can be easily and safely consumed by infants as daily baby food at home and to evaluate the feasibility of these recipes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Feasibility. Evaluate simplicity, reproducibility, continuation, and satisfaction at the time of first intake and after 2 months, based on parents' reports through questionnaires: The total score obtained for the 5-point evaluation question is considered feasible if the total score is at least 3 points for the evaluation item x 3 points or more.
Key secondary outcomes
Adverse events related to the recipe food (allergic symptoms, aspiration, etc.; evaluated by a health care provider during face-to-face contact and contacted when adverse events occur during home consumption)
Intake of nuts 2 months after recipe was provided (evaluated by questionnaire after 2 months)
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
Nutritionists and medical staff developed baby food recipes for walnuts, cashews, peanuts, hazelnuts, and almonds. We will recruit study candidates through our website, social networking sites, posters, and pamphlets through our online form. Candidates come to the National Center for Child Health and Development, and we obtain informed consent for the study participants' caregivers and register them. After the study registration, we provide recipes to the caregivers. We evaluated the recipes using an electronic questionnaire to the participants' caregivers after the registration and two months later.
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
| 5 | months-old | <= |
Age-upper limit
| 18 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants who will be between 5 months and 18 months of age at the start of the study and their caregivers
Key exclusion criteria
1. Infants with complications or history of atopic dermatitis
2. Infants with food allergy history
3. Infants who have not ingested wheat yet
4. Infants who are unable to take baby food in a form suitable for their age group due to swallowing problems
5. Infants whose caregivers cannot communicate adequately in Japanese
6. Infants who suffer from a disease that would interfere with the study
7. Caregivers who are unable to comply with the prohibition of disclosure of the contents of this study and the recipes
8. Physicians determines to be unsuitable for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiwako |
| Middle name | |
| Last name | Yamamoto-Hanada |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo
TEL
03-3416-0611
allergy_reserch@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Hamaguchi |
Organization
National Center for Child Health and Development
Division name
Allergy Center
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo
TEL
03-3416-0611
Homepage URL
allergy_reserch@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
IRB of National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo
Tel
03-3416-0181
rinri@ncchd.go.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
| 2024 | Year | 09 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063369
