UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049330 |
|---|---|
| Receipt number | R000056173 |
| Scientific Title | Relationships between continuous intaking brown rice supplements and the immune system and sleep quality in healthy adults. |
| Date of disclosure of the study information | 2022/11/08 |
| Last modified on | 2024/03/21 00:32:42 |
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Basic information
Public title
Relationships between continuous intaking brown rice supplements and the immune system and sleep quality in healthy adults.
Acronym
Relationships between continuous intaking brown rice supplements and the immune system and sleep quality.
Scientific Title
Relationships between continuous intaking brown rice supplements and the immune system and sleep quality in healthy adults.
Scientific Title:Acronym
Relationships between continuous intaking brown rice supplements and the immune system and sleep quality.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate relationships between intaking a brown rice supplement over 12 weeks and the immune system, sleep quality, physical/mental health conditions, and quality of life.
Basic objectives2
Others
Basic objectives -Others
Healthy adults aged 20-64 will be asked to take a brown rice supplement or placebo for 12 weeks to compare changes in immune function, sleep quality, mental and physical health, quality of life, and cognitive function between the brown rice supplement and placebo groups.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in immune function.
Key secondary outcomes
Changes in sleep quality, physical and mental health, quality of life, and cognitive function.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intaking a brown rice supplement once a day for 12 weeks.
Interventions/Control_2
Intaking a placebo once a day for 12 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healthy adults
(2)Person who can take a brown rice supplement or placebo once a day during the intervention period (12 weeks)
(3)Persons who can provide written consent to participate in the study
Key exclusion criteria
(1)Person who cannot give informed consent
(2)A history of dementia or neurological disease
(3)Have serious diseases (immunological, hepatic, renal, heart, etc.) or allergies
(4)Severe visual or hearing impairment
(5)Have consumed brown rice or brown rice supplements continuously within the last year
(6)Pregnant or lactating mothers
(7)Currently participating in other clinical studies
(8)Difficulties in conducting the research for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8824
Homepage URL
michio.takahashi.a1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Isyoku-dougen-syouyaku research foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
med-kenkyo@grp.tohoku.ac.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 | 11 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | 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 | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056173
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| Registered date | File name |
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