UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051613 |
|---|---|
| Receipt number | R000058878 |
| Scientific Title | A Study on the Effect of Test Food on Cognitive Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2023/07/14 |
| Last modified on | 2023/07/13 16:05:17 |
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Basic information
Public title
A Study on the Effect of Test Food on Cognitive Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Study on the Effect of Test Food on Cognitive Function
Scientific Title
A Study on the Effect of Test Food on Cognitive Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Study on the Effect of Test Food on Cognitive Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of test food on cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test
Key secondary outcomes
Questionnaire on mood
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Active food,12 weeks consumption
Interventions/Control_2
Placebo food,12 weeks consumption
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)Males and females aged 40 to 79 years-old.
2)Subjects whose score of Mini Mental State Examination-Japanese (MMSE-J) is 24 or more at screening tests.
3)Subjects who are aware of forgetfulness, have had others point out forgetfulness or aware of memory decline.
4)Subjects who feel temporal mood depression in daily life.
5)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects (who)
1)have been determined by a physician to have dementia.
2)are taking or have taken drugs related to dementia.
3)have a history of and/or contract serious diseases (eg, diabetes, liver disease, kidney disease, heart disease, cerebrovascular disease).
4)taking supplements that may improve cognitive function.
5)have a history and/or a surgical history of digestive disease affecting digestion and absorption.
6)are under treatment for or have a history of alcoholism.
7)have declared with food allergies.
8)can't stop drinking from a day before each measurement
9)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent and a habit of drinking not less than 4 days a week.
10)with extremely irregular eating habits and rhythm of life.
11)suffering from depression or other psychiatric disorders.
12)are pregnant or planning to become pregnant or breastfeed during the study period.
13) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
14)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
15)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
80
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
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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 | 07 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | 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 | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058878
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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