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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025589
Receipt No. R000029400
Scientific Title Effects of a vegetable and fruit mix juice on postprandial blood glucose elevation
Date of disclosure of the study information 2017/01/23
Last modified on 2018/07/12

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Basic information
Public title Effects of a vegetable and fruit mix juice on postprandial blood glucose elevation
Acronym Effects of a vegetable and fruit mix juice on postprandial blood glucose elevation
Scientific Title Effects of a vegetable and fruit mix juice on postprandial blood glucose elevation
Scientific Title:Acronym Effects of a vegetable and fruit mix juice on postprandial blood glucose elevation
Region
Japan

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

Objectives
Narrative objectives1 1) Confirm that drinking vegetable and fruit mix juice suppresses postprandial blood glucose elevation
2) Grasp the active compounds and mechanism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose levels, delta blood glucose levels, delta Cmax (The peak value of the delta blood glucose levels), IAUC (calculated based on the change of delta blood glucose levels)
Key secondary outcomes Serum insulin concentration, delta serum insulin concentration

Base
Study type Interventional

Study design
Basic design Cross-over
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 7
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Eating 150 g of cooked rice at 30 min before drinking 200 ml of water
Interventions/Control_2 Eating 150 g of cooked rice at 30 min before drinking 200 ml of vegetable juice
Interventions/Control_3 Eating 150 g of cooked rice at 30 min before drinking 200 ml of vegetable and fruit mix juice
Interventions/Control_4 Eating 150 g of cooked rice at 30 min before drinking 200 ml of sugar (glucose, sucrose, fructose) aqueous solution (same sugar composition ratio and amount as the vegetable and fruit mix juice)
Interventions/Control_5 Eating 150 g of cooked rice at 30 min before drinking 200 ml of glucose aqueous solution (same sugar content as the vegetable and fruit mix juice)
Interventions/Control_6 Eating 150 g of cooked rice at 30 min before drinking 200 ml of sucrose aqueous solution (same sugar content as the vegetable and fruit mix juice)
Interventions/Control_7 Eating 150 g of cooked rice at 30 min before drinking 200 ml of fructose aqueous solution (same sugar content as the vegetable and fruit mix juice)
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 cnditions
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 20

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 +81-287-36-2935
Email Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hayashi
Organization Innovation Division, KAGOME CO., LTD.
Division name Nature and Wellness Research Department
Zip code
Address 17 Nishitomiyama. Nasushiobara, Tochigi, Japan
TEL +81-287-36-2935
Homepage URL
Email Hiroki_Hayashi@kagome.co.jp

Sponsor
Institute KAGOME CO., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 23 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
2016 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 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 01 Month 10 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029400

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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