UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063460 |
|---|---|
| Receipt number | R000072631 |
| Scientific Title | A study examining the effects of processed brown rice consumption on maternal health and infant development in pregnant and lactating women. |
| Date of disclosure of the study information | 2026/10/30 |
| Last modified on | 2026/10/29 13:18:22 |
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Basic information
Public title
A study examining the effects of processed brown rice consumption on maternal health and infant development in pregnant and lactating women.
Acronym
A study examining the effects of processed brown rice consumption on maternal health and infant development in pregnant and lactating women.
Scientific Title
A study examining the effects of processed brown rice consumption on maternal health and infant development in pregnant and lactating women.
Scientific Title:Acronym
A study examining the effects of processed brown rice consumption on maternal health and infant development in pregnant and lactating women.
Region
| Japan |
Condition
Condition
Maternal health status and infant development among pregnant and postpartum women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to conduct an exploratory investigation into the effects of consuming processed brown rice (rice with a partially retained sub-aleurone layer) on the physical and mental health of pregnant and postpartum women, as well as on the development of their newborns. This will be achieved by having participants consume this rice over a specified period and analyzing data from questionnaires administered before and after the intervention, alongside physical measurement data of the newborns.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in maternal physical symptoms, mental state, dietary habits, and lifestyle habits before and after the intervention
Key secondary outcomes
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
From the time of obtaining participant consent until the one-month postpartum checkup, participants will continuously consume processed brown rice by replacing part or all of their daily staple food with it.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
[1] Pregnant or postpartum women recruited through the Kamakura City Maternity Support Project, or via participating organizations located within Kamakura City.
[2] Individuals who provide written informed consent to participate in the study.
[3] Individuals who can be followed from the pregnancy period through the one-month postpartum check-up.
[4] Individuals who are able to consistently consume the processed brown rice throughout the study period.
Key exclusion criteria
[1] Individuals with an allergy to processed brown rice or rice
[2] Individuals for whom a physician has determined that dietary restrictions are necessary
[3] Individuals for whom participation in the study is deemed medically inappropriate due to serious complications or other conditions
[4] Any other individuals deemed unsuitable for participation in this study by the principal investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
(Public Interest Incorporated Foundation) Isyoku-Dogen Research Foundation
Division name
Representative Director
Zip code
104-0061
Address
5-10-13 Ginza, Chuo-ku, Tokyo
TEL
03-4334-8868
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Ukezono |
Organization
(Public Interest Incorporated Foundation) Isyoku-Dogen Research Foundation
Division name
Chief researcher
Zip code
104-0061
Address
5-10-13 Ginza, Chuo-ku, Tokyo
TEL
03-4334-8868
Homepage URL
datascience@isyokudogen-fnd.jp
Sponsor or person
Institute
(Public Interest Incorporated Foundation) Isyoku-Dogen Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Self-funded
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kamakura-City
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Society of Glycative Stress Research
Address
6F,Nishishinjuku Mizuma Bldg,3-3-13 Nishishinjuku,Shinjuku-ku,Tokyo
Tel
03-6868-4364
rinri-glycativestress@antiaging-bank.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
| 2026 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072631
