UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043242 |
|---|---|
| Receipt number | R000049350 |
| Scientific Title | Study to examine the effect of continuous test food intake on cognitive function -a pre-test- |
| Date of disclosure of the study information | 2021/02/13 |
| Last modified on | 2021/10/07 10:19:21 |
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Basic information
Public title
Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Acronym
Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Scientific Title
Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Scientific Title:Acronym
Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effect of continuous intake of test food on cognitive function in male and female with cognitive decline between the ages of 60 and 80.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE
Key secondary outcomes
Cognitive function test (eye gaze test), BDNF, IGF-1, IGFBP-3, questionnaire (VAS, QOL)
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
Take 1 packet of test food daily with water after breakfast for 12 weeks
Interventions/Control_2
Take 1 packet of placebo food daily with water after breakfast 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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 60 to 80 years old at the time of informed consent.
2. Japanese male and female
3. Those who have subjective symptoms of cognitive decline and are judged by the investigators to have no problem participating in the study
4. Those who can input their own data into the electronic diary
5. Those who can provide written consent
Key exclusion criteria
1. receiving any types of medicines and/or Chinese medical treatment (Abortive use is acceptable)
2. current or history of serious diseases such as liver, kidney, heart, respiratory organs, endocrinology, and metabolic diseases
3. possible allergic symptoms to the test food
4. score of 23 or less on the Cognitive Function Test (MMSE)
5. experience of taking a neuropsychological test at a hospital, etc.
6. taking health foods (foods or supplements for the purpose of maintaining or recovering health)
7. current or history of drug and/or food allergies
8. participation in another clinical trial within one month before providing consent, participating currently or planning to participate
9. excessive consumption of alcohol (alcohol equivalent 60g or more / day)
10. excessive smoking habits (21 or more cigarettes / day)
11. judged by the investigator to be unsuitable for participating in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Tokuta |
Organization
JELLICE CO., LTD.
Division name
Produvtion & Development group Technical center
Zip code
985-0833
Address
4-4-1 Sakae Tagajo-city Miyagi
TEL
022-361-8821
y.tokuta@jellice.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo
TEL
03-6704-5968
Homepage URL
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
JELLICE 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2021 | Year | 02 | Month | 13 | 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
20
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
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 09 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049350
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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