UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Blackcurrant Foods for Managing Human Carbohydrate Metabolism and Cognitive Wellness
Title of the study (Brief title)	Blackcurrant Foods for Managing Human Carbohydrate Metabolism and Cognitive Wellness
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effects of 4 week blackcurrant consumption to health promotion on adult subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BDNF value after 4 weeks ingestion
Key secondary outcomes	Blood biochemistry, oxidative stress marker, inflammation marker after 4 weeks ingestion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Blackcurrant 6 g/day for 4 weeks
Interventions/Control_2	No treatment
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	50 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Persons who give written informed consent, and have full ethical and regulatory approval 2. Persons who are Japanese and 50-89 years
Key exclusion criteria	1. Persons who are allergic to blackcurrant 2. Persons who took blackcurrant products daily in large quantity 3. Persons who take pharmaceuticals, dairy supplement, health-promoting diet and health food for the purpose of health maintenance related to this trial 4. Persons who were enrolled into other clinical trials within the last one month before agreeing to participate in this trial 5. Persons who are judged unsuitable for participating in this trial by physician
Target sample size	50

Research contact person
Name of lead principal investigator	Toshihiko Osawa
Organization	Aichi Gakuin University
Division name	Department of Health and Nutrition
Address	12 Araike, Iwasaki-cho, Nisshin-shi, Aichi 470-0195, Japan
TEL	0561-73-1111
Email	osawat@dpc.aichi-gakuin.ac.jp

Public contact
Name of contact person	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, 105-0004, JAPAN
TEL	03-6809-2722
Homepage URL
Email	ishikawa@hc-sys.jp

Sponsor
Institute	Aichi Gakuin University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Healthcare Systems Co., Ltd.
Name of secondary funｄer(s)

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	2017 Year 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 19 Day
Anticipated trial start date	2016 Year 08 Month 13 Day
Last follow-up date	2016 Year 09 Month 25 Day
Date of closure to data entry	2016 Year 10 Month 25 Day
Date trial data considered complete	2016 Year 11 Month 15 Day
Date analysis concluded	2016 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 10 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029962