UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level -Open label, single intake crossover comparative method-
Acronym	A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level
Scientific Title	A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level -Open label, single intake crossover comparative method-
Scientific Title:Acronym	A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of single intake of test foods on blood glucose level placebo as a control
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose level
Key secondary outcomes	Insulin level, Glucose dependent insulinotropic polypeptide level, and Glucagon Like Peptide-1 level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
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 foods (research foods 1)
Interventions/Control_2	Ingestion of test foods (research foods 2)
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Japanese males between 20 and 75 years of age. (2) Subjects who voluntarily wish to participate in the clinical trial and provide written consent. (3) Subjects who able to maintain a consistent daily lifestyle during the study period.
Key exclusion criteria	(1) Subjects with serious diseases (diabetes, heart disease, cancer, etc.) or mental illness. (2) Subjects with a history of serious diseases (diabetes, heart disease, liver disease, renal disease, cancer, etc.) in the past. (3) Subjects who have donated more than 200mL of blood in the past month or 400mL within the past 3 months. (4) Subjects who have experienced illness or deterioration of physical condition due to blood collection in the past. (5) Subjects who have symptoms of severe anemia. (6) Subjects who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity. (7) Subjects with possible food or drug allergies to the test foods. (8) Subjects who consume food for specified health use, health food, etc. on a daily basis. (9) Subjects who are otherwise ineligible for participation in this study by the investigater.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Ryosuke Middle name Last name Mastuoka
Organization	Kewpie Corporation
Division name	R&D Division
Zip code	182-0002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL	03-5384-7759
Email	ryosuke_mastuoka@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	182-0002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL	03-5384-7759
Homepage URL
Email	tomomi_tanaka@kewpie.co.jp

Sponsor
Institute	Kewpie Corporation
Institute
Department

Funding Source
Organization	Kewpie Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	CX Wellness Co., Ltd
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
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 09 Month 23 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	16
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	No longer recruiting
Date of protocol fixation	2022 Year 09 Month 07 Day
Date of IRB	2022 Year 09 Month 07 Day
Anticipated trial start date	2022 Year 09 Month 24 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 09 Month 22 Day
Last modified on	2022 Year 09 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055814