UMIN-CTR Clinical Trial

Basic information
Public title	Study on postprandial blood glucose response test food intake in healthy subjects.
Acronym	Study on postprandial blood glucose response test food intake in healthy subjects.
Scientific Title	Study on postprandial blood glucose response test food intake in healthy subjects.
Scientific Title:Acronym	Study on postprandial blood glucose response test food intake in healthy subjects.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of food ingredient on cognitive functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose level
Key secondary outcomes	Blood insulin level Blood Triglyceride level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants 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	Placebo food (a single time intake) > 2-week washout > Test food (a single time intake)
Interventions/Control_2	Test food (a single time intake) > 2-week washout > Placebo food (a single time intake)
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Men and women between the ages of 20 and under 75 who wish to voluntarily participate in clinical trials and obtain written consent. 2. Subjects who can maintain their daily habits during the test period.
Key exclusion criteria	1. Subjects with serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illness. 2. Subjects with a history of serious illness. (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) 3. Subjects who have large changes in diet and exercise and cannot maintain their daily lifestyle. 4. Subjects with food or medicine allergies. 5. Subjects who are taking food for specified health uses or health food products. 6. Others considered as inappropriate for this study by the physician.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Hamachiyo
Organization	Kewpie Corporation
Division name	Senior executive officer
Zip code	182-0002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.
TEL	03-5384-7760
Email	yoshinori_hamachiyo@kewpie.co.jp

Public contact
Name of contact person	1st name Tatsuo Middle name Last name Uetake
Organization	CXwellness, Inc.
Division name	Representative director
Zip code	103-0023
Address	516 Nihonbashinagatani Bldg.,3-1-6,Nihonbashihoncho, Chuo-ku, Tokyo, Japan.
TEL	03-6225-5601
Homepage URL
Email	uetake@cx-wellness.com

Sponsor
Institute	CXwellness, Inc.
Institute
Department

Funding Source
Organization	Kewpie Coroporation
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	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	2021 Year 10 Month 15 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	17
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 08 Month 04 Day
Date of IRB	2021 Year 08 Month 04 Day
Anticipated trial start date	2021 Year 08 Month 04 Day
Last follow-up date	2021 Year 10 Month 27 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 10 Month 13 Day
Last modified on	2022 Year 04 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052222