UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046070 |
|---|---|
| Receipt number | R000052580 |
| Scientific Title | Effects of rush component intake on cognitive function in MCI tendencies |
| Date of disclosure of the study information | 2023/09/16 |
| Last modified on | 2023/01/17 13:43:40 |
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Basic information
Public title
Effects of rush component intake on cognitive function in MCI tendencies
Acronym
Effects of rush component intake on cognitive function in MCI tendencies
Scientific Title
Effects of rush component intake on cognitive function in MCI tendencies
Scientific Title:Acronym
Effects of rush component intake on cognitive function in MCI tendencies
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of 24-week intake of dehydroeffusol-containing foods on cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test
Evaluate before ingestion and 24 weeks after ingestion.
Key secondary outcomes
Hearing test, dexterity test, QOL questionnaire
Evaluate before ingestion and 24 weeks after ingestion.
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
1 grains of the test product daily oral intake for 24 weeks.
Interventions/Control_2
1 grains of the placebo daily oral intake for 24 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
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women between the ages of 65 and 74.
(2) Subjects who are aware of forgetting due to aging.
(3) Subjects who the average T-score of 6 items of Five Cog are lower than 50 in the screening.
Key exclusion criteria
(1) Subjects who constantly use health food richly containing involvement ingredient
(2) Subjects who regularly take drugs or health foods which may affect this study more than once a week
(3) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(4) Subjects suspected of having dementia or mental disorder based on cognitive function tests and physician interviews.
(5) Subjects who have performed the cognitive tests within 3 months prior to the screening.
(6) Subjects at risk of developing allergy in relation to the study.
(7) Subjects who have diseases that require constant medication (excluding high blood pressure, lipid abnormalities and external drugs).
(8) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
(9) Subjects who participated in other clinical studies.
(10) Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ohkawara |
Organization
Satoen Co., LTD.
Division name
None
Zip code
421-1392
Address
1057 Ohhara, Aoi-ku, Shizuoka, Japan
TEL
054-270-1336
okawara358@satoen.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
090-4821-1099
Homepage URL
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Satoen Co., LTD.
HAGIHARA & CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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 | 09 | Month | 16 | 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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052580
