UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045050 |
|---|---|
| Receipt number | R000051457 |
| Scientific Title | To evaluate the effect of food ingredient on cognitive functions. |
| Date of disclosure of the study information | 2021/08/04 |
| Last modified on | 2023/02/06 09:38:50 |
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Basic information
Public title
To evaluate the effect of food ingredient on cognitive functions.
Acronym
To evaluate the effect of food ingredient on cognitive functions.
Scientific Title
To evaluate the effect of food ingredient on cognitive functions.
Scientific Title:Acronym
To evaluate the effect of food ingredient on cognitive functions.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of food ingredient on cognitive functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test score
* Assessed by Cognitrax
* Perform Cognitrax at before consuming and at 6 and 12 weeks after ingestion
Key secondary outcomes
TMT-A, B
SF-36v2
WHO-5
OSA Sleep Inventory
Evaluation of blood parameter values
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 food ingredient (0.3 g/day).
Duration: 12 weeks.
Administration: Take once a day.
Interventions/Control_2
Ingestion of placebo.
Duration: 12 weeks.
Administration: Take once a day.
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.Males and females from 60 to 80 years of age.
2.Subjects who get 26 or more in score of Mini Mental State Examination-Japanese (MMSE-J)
3.Subjects who are experiencing memory loss.
4.Subjects who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria
1.Subjects who have mental health issues such as depression disorder or other issues and medical history or treatment of cerebrovascular disease.
2.Subjects who get 6 or more in score of The Geriatric Depression Scale-Short Form-Japanese (GDS-S-J).
3.Subjects who take medicines that may affect the central nervous system, except sleeping pills.
4.Subjects who take supplements related to improving cognitive functions.
5.Subjects who have visual impairment or hearing impairment.
6.Subjects who have serious liver, kidney, heart, respiratory, endocrine, or metabolic diseases.
7.Heavy smoker ,drinker of alcohol or subjects with disordered lifestyle.
8.Subjects who are allergic to medicines and/or the test food related products.
9.Subjects who constantly use or who can't restrict use medicines (related to Antipsychotics, anxiolytics, antidepressants, antiparkinson's drugs, antidepressants, antiepileptics, anticoagulants, etc.) having a possibility of affecting test results.
10.Subjects who constantly use or who can't restrict use supplements, vitamins and nutrient (related to blood flow and antioxidant effect) having a possibility of affecting test results.
11.Subjects who are participating the other clinical tests.
12.Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
60
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
1030001
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 | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
1050023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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 Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-6455-0880
niho-jimucho@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 | 08 | Month | 04 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 09 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 09 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051457
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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