UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect Rondomised,double blind, placebo controlled crossover study
Acronym	A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect
Scientific Title	A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect Rondomised,double blind, placebo controlled crossover study
Scientific Title:Acronym	A study to evaluate the effects of foods containing indigestible dextrin on the blood glucose elevation inhibitory effect Rondomised,double blind, placebo controlled crossover study
Region	Japan

Condition
Condition	healthy individuals
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the blood glucose elevation inhibitory effect of a single intake of test food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose Insulin
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of study food
Interventions/Control_2	Single ingestion of control food
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subjects of men and women aged 20 to 64 (2)Subjects who received a sufficient explanation of the purpose and contents of the study, an ability to consent, a volunteer who volunteered to participate with a good understanding and who agreed to participate in the study
Key exclusion criteria	(1) Subjects with a history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disorder, and other serious diseases (2) Subjects who may have allergic symptoms due to ingredients in the test food (3) Subjects with impaired cardiopulmonary function (4) Subjects with abnormal liver and kidney function test values (5) Subjects who have undergone gastrointestinal surgery (6) Subjects with a disease currently being treated (7) Subjects with food and drug allergies (8) Subjects who have a habit of smoking (9) Subjects who play intense sports and are on a diet (10) Subjects taking food, health foods, quasi-drugs, and pharmaceuticals (including OTC and prescription drugs) that may affect the endpoints of the study (11) Subjects who are excessively consuming alcohol or subjects who cannot ban alcohol from 2 days before the test date (12) Subjects who are pregnant or who are scheduled to become pregnant or breastfeeding during the study period (13) Subjects who are or will be participating in other clinical studies at the start of this study (14) Other subjects deemed inappropriate by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Zip code	5300044
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	0661355200
Email	info@miura-cl.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Terashima
Organization	Oneness Support Co., Ltd.
Division name	Clinical Trial Division
Zip code	5300044
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	0648018917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	frat field operations 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	Miura Clinic, Medical Corporation Kanonkai IRB
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	0661355200
Email	mterashima@miura-cl.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	2019 Year 09 Month 20 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	Preinitiation
Date of protocol fixation	2019 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date	2019 Year 09 Month 30 Day
Last follow-up date	2019 Year 12 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	2019 Year 09 Month 20 Day
Last modified on	2019 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043384