UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045927 |
|---|---|
| Receipt number | R000052425 |
| Scientific Title | The study to verify the effect of ingestion of Japanese sweets on glycative stress. |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2024/11/07 16:11:16 |
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Basic information
Public title
The study to verify the effect of ingestion of Japanese sweets on glycative stress.
Acronym
The study to verify the effect of ingestion of Japanese sweets on glycative stress.
Scientific Title
The study to verify the effect of ingestion of Japanese sweets on glycative stress.
Scientific Title:Acronym
The study to verify the effect of ingestion of Japanese sweets on glycative stress.
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of Japanese sweets containing sugar, red bean paste, agar, etc. on the increase in blood glucose level after meals in a human test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood-glucose level of before and 15, 30, 45, 60, 90, and 120 minutes after test diet.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Boiled rice is taken.
Interventions/Control_2
Japanese sweets A is taken.
Interventions/Control_3
Japanese sweets B is taken.
Interventions/Control_4
Japanese sweets C is taken.
Interventions/Control_5
Sugar water is taken.
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 and Female
Key inclusion criteria
The person who belongs to Doshisha University Faculty of Life and Medical Sciences / Graduate School of Life and Medical Sciences.
Key exclusion criteria
The person who has trouble with some chronic malady and has a medicine medical treatment at present.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Graduate School of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
610-0394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Graduate School of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
610-0394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
Homepage URL
yyonei@mail.doshisha.ac.jp
Sponsor or person
Institute
Anti-Aging Medical Research Center Graduate School of Life and Medical Sciences,Doshisha University
Institute
Department
Personal name
Funding Source
Organization
TORAYA Confectionery Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Agelab Co,.Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Life and Medical Sciences,Doshisha University
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
Tel
0774-65-6394
yyonei@mail.doshisha.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
| 2021 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000052425
Publication of results
Published
Result
URL related to results and publications
https://www.toukastress.jp/webj/article/2022/GS22-26.pdf
Number of participants that the trial has enrolled
16
Results
The results of the examination of blood glucose changes after yokan intake indicate that Yokan may be a functional food with a smaller effect on glycative stress than rice or sugar intake, if consumed in appropriate amounts.
Results date posted
| 2024 | Year | 11 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The test foods were rice (A) as the reference food, Yokan (B, C, D) as the test food, and sugar water (E) with 50 g of carbohydrate, and the subsequent blood glucose changes were verified.
The glucose change curve for the 16 subjects was higher for test foods E > A > B, C, and D, in that order. delta BG after intake of A was higher than B, C, and D at 90 and 120 min, respectively. delta BG in B was lower than that of E after 45 min. deila BG in C tended to be lower than that of E after 45 min. The iAUCs were higher in the order A > E > B > C > D, with significantly lower values for B, C, and D compared to A. The iAUC of D tended to be lower than that of E. The delta Cmax was higher in the order of E > D > A > B and C. The delta Cmax of B and C tended to be lower than that of E.
Participant flow
Selection of subjects for safety analysis The subjects for the safety analysis were those who had consumed the test food at least once. Selection of subjects for efficacy analysis The subjects for the efficacy analysis were those who completed the prescribed study schedule and reviewed all study details, excluding those who met the exclusion criteria for analysis as described below. Persons whose conduct was conspicuously found to undermine the reliability of the test results. Subjects who were found after the start of study to have met the exclusion criteria or were unable to comply with the restrictions. Statistical analysis The safety evaluation and analysis of the study were performed on the safety analysis subjects, and adverse events and side effects were evaluated by tabulating the symptoms, severity, and frequency of adverse events and side effects.
Adverse events
No adverse events were reported in this study
Outcome measures
delta bloodglucose; delta BG
delta Cmax; maximum blood glucose concentration
incrementalarea under curve; iAUC
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052425
