UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050693 |
|---|---|
| Receipt number | R000057051 |
| Scientific Title | Validation research of improvement effects on cognition by test-food intakes |
| Date of disclosure of the study information | 2024/04/03 |
| Last modified on | 2023/11/22 21:01:54 |
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Basic information
Public title
Validation research of improvement effects on cognition by test-food intakes
Acronym
Validation research of improvement effects on cognition by test-food intakes
Scientific Title
Validation research of improvement effects on cognition by test-food intakes
Scientific Title:Acronym
Validation research of improvement effects on cognition by test-food intakes
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to validate some kind of effect by the test-food intakes on human cognitive functions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test ( Cognitrax: a cognition item)
Key secondary outcomes
1. Questionnaire concerning Quality of Life (World Health Organization: QOL26)
2. Cognitive function test (Cognitrax: the other items)
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
Ingestion of the test food to the subjects, one a day (at breakfast, lunch or dinner).
Interventions/Control_2
Ingestion of the placebo food to the subjects, one a day (at breakfast, lunch or dinner).
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Japanese male/female subjects having an age of not less than 50 years old at informed consent.
(2) Subjects fully realized that the subjects themselves must be in the failure of their cognitive function.
(3) Subjects having a MMSE-J score of not less than twenty-four, at the pre-test.
(4) Subjects having a positive efficacy index about continuous attention on Cognitrax, at the pre-test.
(5) Subjects who can receive the test food once a week and put it in freezing storage.
(6) Subjects who can take the test food for a meal once a day.
(7) Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) who take steadily (not less than four times a week) in medicines (e.g., herbal), foods (e.g., bluefish) and supplements (e.g., DHA, EPA), which might affect human cognitive functions,
(2) who have used (not less than four times a week) an affecting apparatus/application,
(3) suffering from dementia,
(4) with previous and/or current medical history of mental diseases (e.g., depression),
(5) diagnosed as attention deficit hyperactivity disorder,
(6) with color deficiency,
(7) being under the restriction of carbohydrate with dieting,
(8) with extremely irregular eating habits,
(9) restricting their mealtimes to no more than once a day (not less than once a week), within the last month,
(10) with excessive alcohol intake,
(11) having a habit of smoking,
(12) planning to vaccinate after the pre-test to the hospital visiting (12 W),
(13) who will be under a variable condition, such as dietary habits, house-moving, transfer,
(14) whose roomer will partake in this research,
(15) being severe anemic,
(16) with significant changes of their menopausal physical condition,
(17) being under another clinical test with medicine or health food, or partook in that within the past 4 weeks, or will partake in that after giving informed consent,
(18) having previous/current medical history of severe cardiac, hepatic, renal or digestive diseases,
(19) with pregnancy, possibly one, or lactating,
(20) having drug and food allergy (especially to wheat, egg, milk and soybean),
(21) who donated their blood components or blood (0.2 L) within the last month,
(22) who donated his blood (0.4 L) within the past 3 months,
(23) who donated her blood (0.4 L) within the past 4 months,
(24) being collected in total of his blood (1.2 L) within the past 12 months and in this research,
(25) being collected in total of her blood (0.8 L) within the past 12 months and in this research,
(26) determined as ineligible for participation, judging from the principal/sub investigator - - .
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group Inc.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2024 | Year | 04 | Month | 03 | 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
76
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
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057051
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