UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062693 |
|---|---|
| Receipt number | R000071097 |
| Scientific Title | A study to evaluate the effect of bread and potato salad containing reduced digestible dextrin on blood glucose level and postprandial sleepiness -Randomized, open-label, cross-over single intake study- |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/08/26 11:26:28 |
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Basic information
Public title
A study to evaluate the effect of bread and potato salad containing reduced digestible dextrin on blood glucose level and postprandial sleepiness
Acronym
Effect of bread and potato salad with reduced digestible dextrin on blood glucose and sleepiness
Scientific Title
A study to evaluate the effect of bread and potato salad containing reduced digestible dextrin on blood glucose level and postprandial sleepiness -Randomized, open-label, cross-over single intake study-
Scientific Title:Acronym
Effect of bread and potato salad with reduced digestible dextrin on blood glucose and sleepiness
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of bread alone versus bread plus potato salad containing reduced digestible dextrin on blood glucose levels and postprandial sleepiness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level (AUC, Cmax, etc. by Continuous Glucose Monitoring), and Postprandial sleepiness evaluation (VAS and Stanford Sleepiness Scale scores or delta values)
Key secondary outcomes
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
Test food A: Single intake of 73.7 g of white bread
Test food B: Single intake of 56.7 g of white bread + 80 g of potato salad containing 6.8 g of reduced digestible dextrin
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy Japanese males between 20 and 59 years of age.
(2) BMI of 25 or less.
(3) Who voluntarily wish to participate in the clinical trial and provide written consent.
(4) Subjects who have not been advised by a physician to undergo treatment for any illness based on health checkup results within the past year.
(5) Subjects without glucose intolerance or difficulty sleeping in checkups within the past year.
(6) Subjects who are able to maintain a consistent daily lifestyle during the study period.
Key exclusion criteria
(1) Subjects with a history or current history of serious diseases (diabetes, heart disease, liver disease, renal disease, gastrointestinal disease, cancer, etc.) or mental illness.
(2) Subjects who fall under the "D (Medical care required)" judgment category of the Japan Society of Human Dry Dock.
(3) Subjects who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity.
(4) Subjects with possible food or drug allergies to the test foods.
(5) Subjects who routinely consume specified health foods, foods with functional claims, or health foods (including supplements) 3 or more times a week and cannot discontinue them during the study period after obtaining consent.
(6) Subjects who routinely use medications that may affect the study (antibiotics, gastrointestinal regulators, laxatives, medications for mental illness or sleep disorders, etc.) and cannot restrict their use during the study period.
(7) Subjects with sleep disorders (e.g., insomnia, sleep apnea syndrome, circadian rhythm sleep disorder, hypersomnia, etc.).
(8) Subjects currently receiving any drug treatment or outpatient treatment.
(9) Subjects who are otherwise judged ineligible for participation in this study by the lead principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
Human Health Research Department, Innovative Research Institute, R&D Division
Zip code
182-0002
Address
Sengawa Kewport, 2-5-7 Sengawa-cho, Chofu-shi, Tokyo, 182-0002, Japan
TEL
03-5384-7760
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Mengwei |
| Middle name | |
| Last name | Yuan |
Organization
Kewpie Corporation
Division name
Human Health Research Department, Innovative Research Institute, R&D Division
Zip code
182-0002
Address
Sengawa Kewport, 2-5-7 Sengawa-cho, Chofu-shi, Tokyo, 182-0002, Japan
TEL
080-7732-2265
Homepage URL
mengwei_yuan@kewpie.co.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
Tokyo Haneda Watanabe Clinic Ethical Review Committee, Medical Corporation Shaeikai
Address
1-5-16 Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
r.k@kanamori.co.jp
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
| 2026 | Year | 09 | Month | 03 | 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
| 2026 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071097
