UMIN-CTR Clinical Trial

Basic information
Public title	Measuring the glycemic index (GI) of fruit extract
Acronym	Measuring the glycemic index (GI) of fruit extract
Scientific Title	Measuring the glycemic index (GI) of fruit extract
Scientific Title:Acronym	Measuring the glycemic index (GI) of fruit extract
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure the glycemic index (GI) of the test food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	GI
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	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: single dose Test food: Fruit Extract 71.4 g Reference food1: Glucose 25 g Reference food2: Glucose 15.5 g + Fructose 9.5 g Administration: <Test food> After taking blood samples before intake, dissolve the test food in 150 mL of water and drink it. <Reference food> After taking blood samples before intake, dissolve the reference food in 150 mL of water and drink it. * The intervention sequence order is 1) reference food1, 2) reference food1, 3) test food and 4) reference food2. * Washout period between each intervention is for one day and more. * This study conforms to the standards of ISO 26642: 2010.
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healthy Japanese adult subjects 2.Subjects who are 30 kg/m^2 or less in BMI 3.Subjects who have written consent for participation in the study
Key exclusion criteria	1.Subjects with a history of diabetes, cirrhosis, chronic hepatitis, renal failure, heart failure, cerebral infarction, cerebral hemorrhage, myocardial infraction, angina pectoris, a history of cancer, or a history of surgery of the digestive system (esophagus, stomach, duodenum, small intestine, large intestine, rectal, gallbladder, pancreas) 2.Subjects who currently have a disease under treatment 3.Subjects with fruit allergies 4.Subjects who have abnormal glucose tolerance 5.Subjects who take medications known to affect glucose tolerance 6.Subjects who a pregnant, breast-feeding, and planning to become pregnant or breast-feeding 7.Subjects who are participating in other clinical trials or scheduled to participate in the trial or are less than three months after the end of the trial 8.Subjects judged inappropriate by the doctor responsible for the examination
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Medical Corporation Kanonkai, Miura clinic
Division name	Internal medicine
Zip code	530-0044
Address	Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	info@miura.co.jp

Public contact
Name of contact person	1st name Yukino Middle name Last name Koshinaka
Organization	Miki Corporation
Division name	Institute for Health science
Zip code	663-8142
Address	12-4, Naruohama 3, Nishinomiya, Hyogo
TEL	0798-43-1870
Homepage URL
Email	koshinaka@mikiprune.co.jp

Sponsor
Institute	Oneness Support Co., Ltd.
Institute
Department

Funding Source
Organization	Miki Corporation
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	The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address	Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	koshinaka@mikiprune.co.jp

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	2021 Year 12 Month 17 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	2021 Year 12 Month 17 Day
Date of IRB	2021 Year 12 Month 23 Day
Anticipated trial start date	2022 Year 01 Month 06 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 17 Day
Last modified on	2022 Year 06 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052913