UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040780 |
|---|---|
| Receipt number | R000046568 |
| Scientific Title | Establishment of the evaluation method on concentration and Evaluation of polyphenols intake effects on concentration in healthy human |
| Date of disclosure of the study information | 2020/06/16 |
| Last modified on | 2021/03/30 11:02:31 |
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Basic information
Public title
Establishment of the evaluation method on concentration and Evaluation of polyphenols intake effects on concentration in healthy human
Acronym
Evaluation of polyphenols intake effects on concentration in healthy human
Scientific Title
Establishment of the evaluation method on concentration and Evaluation of polyphenols intake effects on concentration in healthy human
Scientific Title:Acronym
Evaluation of polyphenols intake effects on concentration in healthy human
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of polyphenol intake on Concentration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram
(before intake/ after first intake/1 week after)
Key secondary outcomes
Heart rate
Questionnaires
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Polyphenol intake(50mg/day as anthocyanins, 1 week)
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Individuals aged from 20 to 59 years, when giving the informed consent.
2) Individuals giving the written informed consent.
Key exclusion criteria
1) Individuals who declare the allergy symptoms against test diets.
2) Individuals who have anamnesis of cranial nerve disease.
3) Individuals who have anamnesis of the autonomic nervous system.
4) Individuals who have mental symptoms, or who have been diagnosed as mental disorder.
5) Individuals who are being treated with hormone, or who have been diagnosed as menopausal symptoms
6) Individuals who can't perform the study because it's olfactory impairment.
7) Individuals who regularly take drugs or health foods affecting cognitive functions
8) Individuals who regularly take drugs of health foods affecting autonomic nervous system.
9) Individuals who is not suitable for subjects by pre-test questionnaire.
10) Individuals who are planned to participate in other clinical study.
11) Individuals who are pregnant or breastfeeding during the study.
12) Individuals who sometimes have irregular lifestyles during the study.
13) Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Shimizu |
Organization
Tokyo Kasei University
Division name
Faculty of Health Sciences
Zip code
350-1398
Address
2-15-1 Inariyama, Sayama, Saitama, 350-1398
TEL
04-2955-6028
junshimizu06@gmail.com
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Oda |
Organization
INTERCROSS CORPORATION
Division name
representative
Zip code
171-0021
Address
5-5-21-2801, Nishi-Ikebukuro, Toshima-ku, Tokyo
TEL
03-5953-3930
Homepage URL
oda-kazuyuki@intercross.co.jp
Sponsor or person
Institute
INTERCROSS CORPORATION
Institute
Department
Personal name
Funding Source
Organization
Meiji Food Materia Co., Ltd
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
INTERCROSS CORPORATION
Address
5-5-21-2801, Nishi-Ikebukuro, Toshima-ku, Tokyo
Tel
03-5953-3930
oda-kazuyuki@intercross.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
東京家政大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjhr/advpub/0/advpub_202142G04/_pdf/-char/ja
Number of participants that the trial has enrolled
7
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
Main results already published
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2020 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046568
| Research Plan | |
|---|---|
| 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 |
