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

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 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


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

Value
https://center6.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