UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020433 |
|---|---|
| Receipt number | R000023603 |
| Scientific Title | Evaluation of sustainably attenuating effect of postprandial blood glucose elevation by drinking vegetable juice at 30 min before eating meal |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2017/01/04 11:27:00 |
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Basic information
Public title
Evaluation of sustainably attenuating effect of postprandial blood glucose elevation by drinking vegetable juice at 30 min before eating meal
Acronym
Evaluation of second-meal effect by drinking vegetable juice
Scientific Title
Evaluation of sustainably attenuating effect of postprandial blood glucose elevation by drinking vegetable juice at 30 min before eating meal
Scientific Title:Acronym
Evaluation of second-meal effect by drinking vegetable juice
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal that drinking vegetable juice at 30 min before eating meal attenuates postprandial blood glucose elevation during the following meal
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. delta blood glucose level, delta plasma insulin level (calculated by subtraction of the level before breakfast or lunch)
2. delta Gmax, delta Imax (The peak value of the delta blood glucose level or delta plasma insulin level)
3. IAUCg, IAUCi (calculated based on the change of delta blood glucose or delta insulin level)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
<Test 1>
Breakfast: Eating 150 g of cooked rice after drinking 200 mL of water (Total amount of carbohydrates is set at 50 g)
Lunch: Eating curry and rice (200 g of curry roux and 150 g of cooked rice) with 200 mL of water
Wash-out period: 1 week (between test 1 and test 2)
<Test 2>
Breakfast: Eating 109 g of cooked rice after drinking 200 mL of vegetable juice (Total amount of carbohydrates is set at 50 g)
Lunch: Eating curry and rice (200 g of curry roux and 150 g of cooked rice) with 200 mL of water
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who satisfy the following conditions
1) Who do not fit key exclusion criteria
2) Who provide written informed consents
Key exclusion criteria
1) Who has abnormal glucose tolerance in medical check-ups for the prior year
2) Who has food allergy to the test meals
3) Who has remarkable hypersensitivity to alcohol
4) Who will get pregnant or breast-feed during the study period
5) Who join other human studies
6) Who are judged unsuitable for this study by principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Sunabori |
Organization
Innovation Division, Kagome Co., Ltd.
Division name
Nature and Wellness Research Department
Zip code
Address
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL
0287-36-2935
Satoshi_Sunabori@kagome.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Yoshida |
Organization
Innovation Division, Kagome Co., Ltd.
Division name
Nature and Wellness Research Department
Zip code
Address
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL
0287-36-2935
Homepage URL
Kazutaka_Yoshida@kagome.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University
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
| 2016 | Year | 01 | Month | 08 | 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
| 2015 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023603
