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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034944
Receipt No. R000039789
Scientific Title Effect of consuming vegetable juice on postprandial glucose levels
Date of disclosure of the study information 2018/11/21
Last modified on 2018/11/20

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Basic information
Public title Effect of consuming vegetable juice on postprandial glucose levels
Acronym Effect of consuming vegetable juice on postprandial glucose levels
Scientific Title Effect of consuming vegetable juice on postprandial glucose levels
Scientific Title:Acronym Effect of consuming vegetable juice on postprandial glucose levels
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the efeect of tomato jyuice on postprandial glucose parameters.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incremental area under the glucose curve
Key secondary outcomes Incremental glucose peak
Standard deviation for blood glucose

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 1.Tomato juice
Participants consume tomato juice at 30 min before rice and examine the blood glucose at 0,30,60,120,180 min after consuming rice and test meal lunch by self-monitoring blood glucose test.
Interventions/Control_2 2.Tomato
Participants consume tomato at 30 min before rice and examine the blood glucose at 0,30,60,120,180 min after consuming rice and test meal lunch by self-monitoring blood glucose test.
Interventions/Control_3 3. Contorol (water)
Participants consume water at 30 min before rice and examine the blood glucose at 0,30,60,120,180 min after consuming rice and test meal lunch by self-monitoring blood glucose test.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.Healthy volunteers
2.Individuals whose written informed consents have been obtained
3.Individuals who are judged appropriate for the study by the principal
Key exclusion criteria 1.Patients with type 2 and type 2 diabetes
2.Treatment with steroid
3.Women with possibility of pregnancy or pregnant
4.Sever health problems not suitable for the study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Imai, Saeko
Organization Kyoto Women's University
Division name Food and Nutrition
Zip code
Address 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL 075-531-7128
Email imais@kyoto-wu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Imai, Saeko
Organization Kyoto Women's University
Division name Food and Nutrition
Zip code
Address 35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL 075-531-7128
Homepage URL
Email imais@kyoto-wu.ac.jp

Sponsor
Institute Kyoto Women's University
Institute
Department

Funding Source
Organization Kyoto Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 京都女子大学(京都)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 21 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 21 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 10 Month 30 Day
Date analysis concluded
2020 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 20 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039789

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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