UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of food ingredient in healthy adult on the suppression of blood glucose elevation -crossover comparison study-
Acronym	A study to evaluate the effect of food ingredient in healthy adult on the suppression of blood glucose elevation
Scientific Title	A study to evaluate the effect of food ingredient in healthy adult on the suppression of blood glucose elevation
Scientific Title:Acronym	A study to evaluate the effect of food ingredient in healthy adult on the suppression of blood glucose elevation -crossover comparison study-
Region	Japan

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

Objectives
Narrative objectives1	To evaluate differences in the effect of single intake of test food on postprandial blood glucose levels compared to the control food
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood glucose
Key secondary outcomes	Insulin, GLP-1

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food(research food1)
Interventions/Control_2	Ingestion of test food(research food2)
Interventions/Control_3	Ingestion of placebo
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) Kewpie Co., Ltd. employees who voluntarily wish to participate in the study and provide written consent (2) Men and women between the ages of 20 and 50 who are healthy and are not being treated for a disease (3) Subjects who are able to maintain a certain daily lifestyle during the study period
Key exclusion criteria	(1) Subjects who suffer from serious diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illness (2) Subjects with a history of serious diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) in the past (3) Subjects who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity (4) Subjects with possible food allergy or drug allergy to the test food (5) Subjects who consume food for specified health use, health food, etc. on a daily basis (6) Subjects who are otherwise deemed ineligible by the investigator to participate in this study
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Ryosuke Middle name Last name Matsuoka
Organization	Kewpie Corporation
Division name	R&D Division
Zip code	1820002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL	03-5384-7759
Email	ryosuke_matsuoka@kewpie.co.jp

Public contact
Name of contact person	1st name Tomomi Middle name Last name Tanaka
Organization	Kewpie Corporation
Division name	R&D Division
Zip code	1820002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL	03-5384-7759
Homepage URL
Email	tomomi_tanaka@kewpie.co.jp

Sponsor
Institute	Kewpie Co., Ltd.
Institute
Department

Funding Source
Organization	Kewpie 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	Ethical Committee of Ueno Asagao Clinic
Address	6F Kairaku Building, 2-7-5 Higashi-Ueno, Taito-ku, Tokyo
Tel	03-6240-1162
Email	info@ueno-asagao.clinic

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	2022 Year 05 Month 31 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	2022 Year 04 Month 22 Day
Date of IRB	2022 Year 05 Month 09 Day
Anticipated trial start date	2022 Year 05 Month 31 Day
Last follow-up date	2022 Year 11 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	2022 Year 05 Month 12 Day
Last modified on	2022 Year 05 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054418