UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049672 |
|---|---|
| Receipt number | R000056575 |
| Scientific Title | Study of the effect on cognitive function by continuous intake of polyamine |
| Date of disclosure of the study information | 2022/12/02 |
| Last modified on | 2023/06/07 12:38:44 |
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Basic information
Public title
Study of the effect on cognitive function by continuous intake of polyamine
Acronym
Study of the effect on cognitive function by continuous intake of polyamine
Scientific Title
Study of the effect on cognitive function by continuous intake of polyamine
Scientific Title:Acronym
Study of the effect on cognitive function by continuous intake of polyamine
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on improving cognitive function by continuous intake of capsules containing polyamine for 12 weeks in Japanese aged 40 and over.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function tests (Cognitrax)
Key secondary outcomes
Mini Mental State Examination
Questionnaire regarding cognitive function (VAS)
Blood pressure (Systolic, Diastolic and plus)
Questionnaire regarding stress (VAS)
Japanese Perceived Stress Scale
Brief Job Stress Questionnaire
Urine polyamine
Blood polyamine
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Ingest 3 tablets of the test foods (capsules containing polyamine) each after breakfast, lunch and dinner (total 9 tablets) daily for 12 weeks.
Interventions/Control_2
Ingest 3 tablets of the test foods (placebo) each after breakfast, lunch and dinner (total 9 tablets) daily 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 40 years old or more when obtaining consent
3. Persons who are aware of forgetfulness
4. Persons whose MMSE score is 24 or higher at screening
Key exclusion criteria
1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Patients suffering from cancer, familial colorectal adenomatosis, or H. pylori infection.
3. Persons who have any allergies to the ingredients used in the test food (especially persons who have allergies to wheat)
4. Persons who regularly take of polyamine-containing supplements
5. Persons who consume at least one pack of natto every day.
6. Persons who consume at least one pack of soy milk (approximately200ml) every day.
7. Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect cognitive function.
8. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
9. Persons who were judged as inappropriate for study participants by the principal investigator
10. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Nishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
nishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Nishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
nishikawa@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYOBO 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2022 | Year | 12 | Month | 02 | 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
54
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
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056575
| 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 |
