UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of sustainably attenuating effect of postprandial blood glucose elevation by drinking vegetable juice at 30 min before eating meal
Title of the study (Brief title)	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	Satoshi Sunabori
Organization	Innovation Division, Kagome Co., Ltd.
Division name	Nature and Wellness Research Department
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	0287-36-2935
Email	Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person	Kazutaka Yoshida
Organization	Innovation Division, Kagome Co., Ltd.
Division name	Nature and Wellness Research Department
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	0287-36-2935
Homepage URL
Email	Kazutaka_Yoshida@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	Laboratory of Drug Safety Management, Faculty of Pharmaceutical Sciences, Josai University
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	2016 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023603