UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053587 |
|---|---|
| Receipt number | R000060989 |
| Scientific Title | Elucidation of the effects of ultra-high hydrostatic pressurizing brown rice on physiological functions in the elderly |
| Date of disclosure of the study information | 2024/02/09 |
| Last modified on | 2024/02/09 19:23:22 |
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Basic information
Public title
Verification of the effect of ultra-high hydrostatic pressurizing brown rice on physiological functions in the elderly
Acronym
Effects of ultra-high hydrostatic pressurizing brown rice on human physiological functions
Scientific Title
Elucidation of the effects of ultra-high hydrostatic pressurizing brown rice on physiological functions in the elderly
Scientific Title:Acronym
Analysis of the effects of ultra-high hydrostatic pressurizing brown rice on human physiological functions
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the safety of long-term consumption of ultra-high hydrostatic pressurized brown rice and its effects on physiological functions of healthy elderly people.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive and emotional function, bone mineral density, blood pressure, blood biochemical tests, bone metabolism markers, blood monoamine levels, and body composition will be evaluated at 12 and 24 months after the start of treatment.
Key secondary outcomes
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
Individuals who consume 12-24 months of ultra-high hydrostatic press brown rice
Interventions/Control_2
Individuals who consume 12-24 months of white rice
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Between 65 and 85 years of age at the baseline.
(2) Cognitive function test scores at the baseline must meet the following criteria
1) MMSE total score of 22 points or more
2) HDS-R score of 21 or more
(3) Have obtained written consent from the subject to participate in the study.
(4) Possible to converse in Japanese.
Key exclusion criteria
Volunteers with any medical illness, including cardiac, renal, hepatic, respiratory disease, diabetes mellitus, or osteoporosis, with metabolic, endocrine, or hematological diseases, those eating brown rice daily, consuming supplements to treat bone diseases or to prevent osteoporosis and/or improve cognitive and mental function that could influence the results of the study, and smokers and those with allergies and hypersensitivity were excluded.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Hashimoto |
Organization
Shimane university
Division name
Faculty of Medicine
Zip code
6938501
Address
89-1, Enya-cho, Izumo, Shimane, Japan
TEL
0853202730
michio1@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Matsuzaki |
Organization
Shimane university
Division name
Faculty of Medicine
Zip code
693-8501
Address
89-1, Enya-cho, Izumo, Shimane, Japan
TEL
0853202114
Homepage URL
matuzaki@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
KENTARO
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane university
Address
89-1, Enya-cho, Izumo, Shimane 693-8501, Japan
Tel
0853232111
michio-1@med.shimane-u.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
| 2024 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f3.cgi
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled
52
Results
At 24-month after commencing intervention, the mean change in the FAB-sub item 1 scores was higher in the UBR group compared to the WR group. Furthermore CADiscore and plasma epinephrine levels increased. These results indicate that a 2-year oral consumption of UBR increases information processing speed (as a measure of cognitive function), suggesting a protective effect of UBR administration against age-related decline in brain cognition.
Results date posted
| 2024 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1) The applicant must be between 65 and 85 years of age.
(2) Cognitive function test scores at the start of the study must meet the following criteria
(1) Total MMSE score must be 22 or higher.
(2) HDS-R score must be 21 or higher.
(3) Have obtained written consent from the subject to participate in the study.
(4) The subject must be able to converse in Japanese.
Participant flow
All participants underwent a physical examination, including physical measurements and blood biochemistry tests, and were screened for any medical conditions that might affect the study results, such as cardiac, renal, hepatic, respiratory, diabetic, osteoporosis, metabolic, endocrine, hematologic, or bone disease treatments or taking drugs or supplements for geriatric diseases. Volunteers with medical conditions that could affect the study results, such as taking medications or supplements for metabolic, endocrine, hematologic, or bone diseases or for geriatric diseases, were excluded. Participants who smoked or had allergies or hypersensitivities were also excluded.
Adverse events
No adverse events were noted as a result of blood biochemistry tests, self-administered questionnaires, and physician interviews.
Outcome measures
Physical examination, blood biochemistry tests, cognitive function tests, emotional tests, bone density tests, APOE gene polymorphism test, adverse event evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2018 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060989
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