UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028318 |
|---|---|
| Receipt number | R000032413 |
| Scientific Title | Grasp of blood glucose level fluctuation after ingesting vegetable juices and sugar solution. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2018/07/12 09:21:50 |
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Basic information
Public title
Grasp of blood glucose level fluctuation after ingesting vegetable juices and sugar solution.
Acronym
Grasp of blood glucose level fluctuation after ingesting vegetable juices and sugar solution.
Scientific Title
Grasp of blood glucose level fluctuation after ingesting vegetable juices and sugar solution.
Scientific Title:Acronym
Grasp of blood glucose level fluctuation after ingesting vegetable juices and sugar solution.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to clarify differences of blood glucose concentration and blood insulin concentration after ingest each drink, vegetable juice, vegetable fruits mixed juice, aqueous solution containing sugar of the same composition and amount as the vegetable fruit mixed juice, an aqueous solution containing the same amount of sugar as the sugar contained in the vegetable fruit mixed juice.
Basic objectives2
Others
Basic objectives -Others
Blood glucose concentration and blood insulin concentration.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose concentration(before ingestion, after ingestion 15min, 30min, 45min, 60min, 90min, 120min), delta blood glucose concentration(after ingestion 15min, 30min, 45min, 60min, 90min, 120min), delta blood glucose concentration area under curve(AUC)
Key secondary outcomes
Blood insulin concentration(before ingestion, after ingestion 15min, 30min, 45min, 60min, 90min, 120min), delta blood insulin concentration(after ingestion 15min, 30min, 45min, 60min, 90min, 120min), delta blood insulin concentration area under curve(AUC)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Those who ingest 200mL of vegetable juice at 9 AM and measures blood glucose concentration and blood insulin concentration.
Interventions/Control_2
Those who ingest 200mL of vegetable fruits mixed juice at 9 AM and measures blood glucose concentration and blood insulin concentration.
Interventions/Control_3
Those who ingest 200mL of aqueous solution containing sugar of the same composition and amount as the vegetable fruit mixed juice at 9 AM and measures blood glucose concentration and blood insulin concentration.
Interventions/Control_4
Those who ingest 200mL of an aqueous solution containing the same amount of sugar as the sugar contained in the vegetable fruit mixed juice at 9 AM and measures blood glucose concentration and blood insulin concentration.
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
Those who are healthy adult men and women and have obtained informed consent
Key exclusion criteria
1.Those who have obtained diagnostic results above the reference value of diabetes mellitus (fasting blood sugar level 126 mg/dL or more, or HbA1c value 6.5% or more) in the latest medical examination.
2.Food allergy to test food.
3.Those who of alcohol hypersensitivity which makes alcohol disinfection difficult.
4.Those who planning to become pregnant or lactating during the examination period.
5.Those who participate in other human tests involving intake of foods rich in carotenoid at the start of this study.
6.Those who judged that the investigator's doctor is inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Sunabori |
Organization
Kagome Co.Ltd.
Division name
Innovation division, Nature&Wellness research department
Zip code
Address
Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL
0287-36-2935
Satoshi_Sunabori@kagome.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Kagome Co.Ltd.
Division name
Innovation division, Nature&Wellness research department
Zip code
Address
Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL
0287-36-2935
Homepage URL
Hiroki_Hayashi@kagome.co.jp
Sponsor or person
Institute
Kagome Co.Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kagome Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
カゴメ株式会社イノベーション本部（栃木県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 21 | Day |
Last modified on
| 2018 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032413
