UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053931 |
|---|---|
| Receipt number | R000061555 |
| Scientific Title | A study to evaluate the effect of food ingredient in healthy adult on the blood glucose level -Open label,single intake comparative method |
| Date of disclosure of the study information | 2024/03/22 |
| Last modified on | 2024/05/21 09:42:02 |
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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 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 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
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level,Insulin level
Key secondary outcomes
Glucose dependent insulinotropic polypeptide level,and Glucagon Like Peptide-1 level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo food (a single time intake)>1 week washout >Test foods (a single time intake)
Interventions/Control_2
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
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
ryosuke_mastuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness Company Limited
Division name
Representative Director
Zip code
173-0004
Address
2-63-9-401 Itabashi, Itabashi-ku, Tokyo, Japan
TEL
03-6915-5507
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CXwellness Company Limited
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
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
| 2024 | Year | 03 | Month | 22 | 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
| 2024 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061555
