UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042995 |
|---|---|
| Receipt number | R000049089 |
| Scientific Title | Study to evaluate the effect of continuous intake of test food on cognitive function |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2021/10/07 10:21:04 |
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Basic information
Public title
Study to evaluate the effect of continuous intake of test food on cognitive function
Acronym
Study to evaluate the effect of continuous intake of test food on cognitive function
Scientific Title
Study to evaluate the effect of continuous intake of test food on cognitive function
Scientific Title:Acronym
Study to evaluate the effect of continuous intake of test food on cognitive function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of ingesting test food for 12 weeks on men and women aged between 40 and 80 years who are aware of cognitive decline but have no other health problems.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE
Key secondary outcomes
Visual cognitive function test
Subjective symptom questionnaire
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 3 tablets of test food after breakfast daily
Interventions/Control_2
Take 3 tablets of placebo after breakfast daily
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age between 20 and 64 years at the time of informed consent.
2. Japanese male or female.
3. Participants who are aware of forgetfulness or have been pointed out by others about forgetfulness.
4. Participants who are able to input electronic diary with smartphone / PC.
5. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria
1. taking medication or Chinese medication (except for the drugs as needed)
2. on diet / exercise therapy under the guidance of a doctor
3. strabismus
4. current or history of serious diseases such as liver, kidney, heart, respiratory, endocrine and metabolic diseases.
5. current or history of mental disorders (including depressive symptoms) or cerebrovascular disease
6. experience of taking a neuropsychological test at a hospital etc.
7. MMSE score of =<23
8. taking healthy food or supplements daily (subjects who can stop taking those after providing consent are acceptable)
9. current or history of allergy for some drugs or food (possible allergy for test food)
10. participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate
11. pregnant or lactating, or willing to be pregnant during the trial
12. alcohol consumption of >60g equivalent
13. smoker
14. working in shift or late at night, irregular life rhythms
15. judged by the investigator to be unsuitable for participating in this study
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Jinwei |
| Middle name | |
| Last name | Yang |
Organization
TOKIWA Phytochemical Co., Ltd.
Division name
Research and Development Department
Zip code
285-0801
Address
158 Kinoko, Sakura-shi, Chiba
TEL
043-498-0007
k-you@tokiwaph.co.jp
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
Japan Cassis Association
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | Month | 25 | 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
14
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 | 12 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 11 | 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 | 01 | Month | 13 | 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=R000049089
| 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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| Registered date | File name |
