UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058264 |
|---|---|
| Receipt number | R000066607 |
| Scientific Title | A study on the suppressive effects of water jelly (Mizu-yokan) containing the rare sugar allulose on postprandial blood glucose and insulin secretion |
| Date of disclosure of the study information | 2025/06/24 |
| Last modified on | 2025/06/24 15:59:30 |
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Basic information
Public title
A study to investigate the effect of water jelly (Mizu-yokan) containing the rare sugar 'Allulose' on postprandial blood glucose levels
Acronym
A study to investigate the effect of water jelly (Mizu-yokan) containing 'Allulose' on postprandial blood glucose levels
Scientific Title
A study on the suppressive effects of water jelly (Mizu-yokan) containing the rare sugar allulose on postprandial blood glucose and insulin secretion
Scientific Title:Acronym
A study on the suppressive effects of water jelly (Mizu-yokan) containing allulose on postprandial blood glucose and insulin secretion
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to obtain data from human subjects to verify the suppressive effect on postprandial blood glucose of 'Mizu-yokan supplemented with rare sugar,' developed as a functional Japanese confectionery. The study aims to accumulate data to verify whether Mizu-yokan supplemented with allulose suppresses postprandial blood glucose elevation compared to a control Mizu-yokan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose levels and plasma insulin concentrations (measured a total of 7 times: before intake, and at 30, 60, 90, 120, 150, and 180 minutes after intake).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Single intake of Mizu-yokan (60 g/piece) supplemented with 6g of allulose as a sweetener.
Interventions/Control_2
Single intake of Mizu-yokan (60 g/piece) using only sucrose as a sweetener.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult male and female students enrolled at Nakamura Gakuen University
Key exclusion criteria
Individuals with a history of diabetes, impaired glucose tolerance, respiratory diseases, chronic gastrointestinal diseases (inflammatory bowel disease, irritable bowel syndrome, functional dyspepsia, etc.), abdominal surgery, abnormal bowel movements, blood disorders, or food allergies. Individuals with a BMI of 25.0 or higher. Smokers, those with excessive alcohol consumption habits, and pregnant or lactating women. Individuals who routinely consume medications, Foods for Specified Health Uses (FOSHU), Foods with Function Claims, or health foods that may affect the study results
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Department of Nutritional Sciences, Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
tanabek@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Department of Nutritional Sciences, Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
Homepage URL
tanabek@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Koka Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nakamura Gakuen University
Address
5-7-1 Befu, Jonan-ku, Fukuoka
Tel
092-851-2598
tanabek@nakamura-u.ac.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
| 2025 | Year | 06 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066607
