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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026078
Receipt No. R000029962
Scientific Title Blackcurrant Foods for Managing Human Carbohydrate Metabolism and Cognitive Wellness
Date of disclosure of the study information 2017/02/10
Last modified on 2017/02/10

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Basic information
Public title Blackcurrant Foods for Managing Human Carbohydrate Metabolism and Cognitive Wellness
Acronym Blackcurrant Foods for Managing Human Carbohydrate Metabolism and Cognitive Wellness
Scientific Title Blackcurrant Foods for Managing Human Carbohydrate Metabolism and Cognitive Wellness
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshihiko Osawa
Organization Aichi Gakuin University
Division name Department of Health and Nutrition
Zip code
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
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2016 Year 05 Month 19 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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