UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057195 |
|---|---|
| Receipt number | R000065370 |
| Scientific Title | Effect of Confectionery ingestion on Glucose Metabolism |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/03/03 18:51:29 |
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Basic information
Public title
Effect of Confectionery ingestion on Glucose Metabolism
Acronym
Effect of Confectionery ingestion on Glucose Metabolism
Scientific Title
Effect of Confectionery ingestion on Glucose Metabolism
Scientific Title:Acronym
Effect of Confectionery ingestion on Glucose Metabolism
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of Confectionery ingestion on Glucose Metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose Metabolism
Key secondary outcomes
VAS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of a test food 1
Interventions/Control_2
Single intake of a test food 2
Interventions/Control_3
Single intake of a test food 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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Japanese males aged 20-30 years
2)Individuals whose written informed consent has been obtained
3)Individulals who can visit an inspection facility and collect multiple blood samples (6 times/1 day x 3 observations) in designated days
4)Healthy subjects
* Individulals who does not have serious organ damage or disease, is not receiving any related treatment, or is not receiving any type of medication
5)Subjects with a BMI 20-24.9
Key exclusion criteria
1)Individuals with chronic diseases or disorders of the liver, biliary tract, digestive system, circulatory system, respiratory system, kidney, urinary system, mental, neurological system, or blood system
2)Individuals who smoke
3)Individuals who may change their lifestyle during the study period (Night shifts, long trips, etc.)
4)Individuals who do not like to consume highly sweet foods, sweets, or beverages
5)Individuals whose lifestyle is irregular such as always working at night
6)Individuals who attend hospital, take medication, or receive treatment
* Individuals who are receiving treatment or medication for diabetes
7)Individuals who have or have been diagnosed with lifestyle-related diseases such as individuals whose fasting blood glucose level is in the diabetic range
8)Individuals who have severe anemia
9)Individuals who have taken medication for the treatment of disease in the past 1 month (Excluding headaches, menstrual cramps, and colds)
10)Individuals who were hospitalized and received treatment in the past 6 months
11)Individuals who drink a lot of alcohol (60 g or more of alcohol per day)
12)Individuals who are participating in other clinical trial, are scheduled to participate in other clinical trial within 4 weeks after completion of the trial, or after consent to participate in the trial
13)Individuals who are allergic to medicines or foods
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iemoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
n-iemoto-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Yoshikawa |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
m-yoshikawa-ja@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & Co., Ltd.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 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
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 20 | 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 | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065370
