UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038465 |
|---|---|
| Receipt number | R000043802 |
| Scientific Title | Evaluation of cognitive function maintenance or improvement effect of functional food in healthy adults -Placebo-controlled randomized, double-blind study- |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/11 09:40:14 |
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Basic information
Public title
Evaluation of cognitive function maintenance or improvement effect of functional food in healthy adults
-Placebo-controlled randomized, double-blind study-
Acronym
Evaluation of cognitive function maintenance or improvement effect of functional food in healthy adults
Scientific Title
Evaluation of cognitive function maintenance or improvement effect of functional food in healthy adults
-Placebo-controlled randomized, double-blind study-
Scientific Title:Acronym
Evaluation of cognitive function maintenance or improvement effect of functional food in healthy adults
Region
| Japan |
Condition
Condition
Healthy elderly adults with poor cognitive performance, MCI
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the maintenance or improvement effect of cognitive function and the safety when the elderly subjects take functional food for 12 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax
Key secondary outcomes
Various cognitive function tests and questionnaires, blood and urine tests
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 functional food for 12 weeks
Interventions/Control_2
Ingestion of placebo 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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged greater than or equal to 40 years, less than 80 years at the time of obtaining informed consent.
2. Subjects with MMSE score of 24 to 29 at screening.
3. Subjects who have subjective forgetfulness or have been pointed out forgetfulness by others.
4. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Key exclusion criteria
1. Subjects who judged by a doctor as dementia.
2. Subjects who have taken or had taken drugs of dementia.
3. Subjects who regularly take drugs that may affect cognitive functions.
4. Subjects who have current medical history or past medical history of mental disorders (including depressive symptoms) or cerebrovascular diseases.
5. Subjects who regularly use supplements or health foods that may affect cognitive functions.
6. Subjects who judged inappropriate as subjects as a result of clinical examination of screening.
7. Subjects with gerontological depression scale (GDS-S-J) scores of 6 or more.
8. Subjects who have history of alcohol dependence or current medical history.
9. Subjects who consume a large amount of alcohol routinely.
10. Subjects who have serious illness or medical history such as diabetes, liver disease, kidney disease, heart disease.
11. Subjects who have medical history or history of food allergies or current medical history.
12. Subjects who have color vision disorder and can not easily hear people's talk at short distance.
13. Subjects who have problems with the functions of both hands due to injury, surgery, etc.
14. Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
15. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
Shibaura OMODAKA Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, 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
Nihonbashi Cardiovascular Department Clinic Ethics Committee
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
yiwama@well-sleep.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 | 03 | Month | 01 | 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
| 2019 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2021 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043802
