UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026078 |
|---|---|
| Receipt number | 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 09:35:05 |
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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
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
ishikawa@hc-sys.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029962
