UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a vegetable and fruit mix juice on postprandial blood glucose elevation
Title of the study (Brief title)	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	Satoshi Sunabori
Organization	Innovation Division, KAGOME CO., LTD.
Division name	Nature and Wellness Research Department
Address	17 Nishitomiyama. Nasushiobara, Tochigi, Japan
TEL	+81-287-36-2935
Email	Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person	Hiroki Hayashi
Organization	Innovation Division, KAGOME CO., LTD.
Division name	Nature and Wellness Research Department
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 12 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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