UMIN-CTR Clinical Trial

Basic information
Public title	A study for measurement of Glycemic Index (GI) of two kinds of foods in adult males and females
Acronym	A study for measurement of Glycemic Index (GI) of two kinds of foods
Scientific Title	A study for measurement of Glycemic Index (GI) of two kinds of foods in adult males and females
Scientific Title:Acronym	A study for measurement of Glycemic Index (GI) of two kinds of foods
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measure the GI values of two kinds of test foods
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic Index
Key secondary outcomes	Maximum blood glucose level (Cmax) Amount of change in blood glucose levels based on the blood glucose level before loading, Incremental area under the blood glucose response curve (IAUC), Area under the curve(AUC) Amount of change in insulin levels based on the insulin level before loading, Incremental area under the insulin response curve (IAUC), Area under the curve(AUC) Amount of change in questionnaire on Appetite(VAS-questionnaire) based on the appetite(VAS-questionnaire) before loading

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of a reference food (single ingestion) - washout period - a test food 1(single ingestion) - washout period - a test food 2(single ingestion)
Interventions/Control_2	Intake of a reference food(single ingestion) - washout period - a test food 2 (single ingestion) - washout period - a test food 1(single ingestion)
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 males and females aged between 20 and 50 (2) Subjects who have a difference within 25% in the incremental area under the curve (IAUC) of two preliminary tests (3) Women have a stable menstrual cycle (4) Subjects with blood glucose level greater than 70 mg /dL or more and 110 mg /dL or less in glucometer
Key exclusion criteria	(1) Subjects routinely taking medicine or health food which may influence glucose metabolism (2) Subjects whose BMI exceeds 30.0 kg/m2 (3) Subjects whose blood glucose level exceeds 126 mg/dL (4) Subjects who have been pointed out as impaired glucose tolerance within 1 year (5) Subjects who are suspected as impaired glucose tolerance in preliminary examination (6) Subjects whose blood glucose level exceeds 110 mg/dL in glucometer on admission (7) Subjects planned to travel abroad during the study period (8) Subjects having possibilities for emerging allergy related to the current study (9) Subjects who drink much alcohol (10) Subjects who do excessive smoking (11) Subjects who donated blood (blood donation etc.) exceeding 200 mL within 1 month or 400 mL within 4 months (12) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (13) Subjects who have under treatment (e.g.,adiposity,hyperlipidemia, hypertension) that affects the evaluation of this study or medical history of serious illness for medication (14) Subjects whose values of physical measurement, physical examination and clinical laboratory are significantly different from the reference range (15) Subjects who may be pregnant or are pregnant, breastfeeding, or those who desire pregnancy during the study period (16) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (17) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (18) Subjects who are judged as ineligible by the clinical investigator
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Fumitoshi Middle name Last name Horie
Organization	Aisei Hospital Ueno Clinic
Division name	Director, Surgical
Zip code	110-0015
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
TEL	03-3834-3518
Email	cl-rece@aisei-byouin.or.jp

Public contact
Name of contact person	1st name Kunihiko Middle name Last name Wasaki
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.wasaki@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Mizkan Holdings 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	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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 06 Month 14 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	2019 Year 06 Month 13 Day
Date of IRB	2019 Year 06 Month 13 Day
Anticipated trial start date	2019 Year 06 Month 15 Day
Last follow-up date	2019 Year 09 Month 30 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 06 Month 14 Day
Last modified on	2020 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042243