UMIN-CTR Clinical Trial

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
Email	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
Email	oda-kazuyuki@intercross.co.jp

Sponsor
Institute	INTERCROSS CORPORATION
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046568