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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026959
Receipt No. R000030919
Scientific Title Exploratory test on the influence of bean sprout intake on postprandial blood glucose level
Date of disclosure of the study information 2017/04/12
Last modified on 2017/06/01

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Basic information
Public title Exploratory test on the influence of bean sprout intake on postprandial blood glucose level
Acronym Exploratory test on the influence of bean sprout intake on postprandial blood glucose level
Scientific Title Exploratory test on the influence of bean sprout intake on postprandial blood glucose level
Scientific Title:Acronym Exploratory test on the influence of bean sprout intake on postprandial blood glucose level
Region
Japan

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

Objectives
Narrative objectives1 Verify the effect of bean sprouts on postprandial blood glucose levels.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glycemic Index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Rice 150 g
Interventions/Control_2 Rice 145 g and soybean sprout 40 g
Interventions/Control_3 Rice 145 g and petite tomato 40 g
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
50 years-old >=
Gender Male and Female
Key inclusion criteria 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who is 20 years old or more and under 50 years old
3. Persons whose BMI is 30 or less
4. Persons who do not have impaired glucose tolerance in the past one year examination
5. Persons who are not taking drugs such as antihypertensive agents
Key exclusion criteria 1. Persons who are allergic to the test food
2. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
3. Persons who are pregnant, planning or hoping to be pregnant during the study period
4. Persons who are breastfeeding
5. Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size 30

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, 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
TEL 0368092722
Homepage URL
Email ishikawa@hc-sys.jp

Sponsor
Institute Saladcosmo Co., Ltd.
Institute
Department

Funding Source
Organization Saladcosmo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Healthcare Systems Co., Ltd.
Aichi Gakuin University
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 04 Month 12 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
2017 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 12 Day
Last follow-up date
2017 Year 05 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 12 Day
Last modified on
2017 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030919

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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