UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047736 |
|---|---|
| Receipt number | R000054418 |
| Scientific Title | A study to evaluate the effect of food ingredient in healthy adult on the suppression of blood glucose elevation |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2022/05/12 14:56:36 |
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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
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
tomomi_tanaka@kewpie.co.jp
Sponsor or person
Institute
Kewpie Co., Ltd.
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054418
