UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052744 |
|---|---|
| Receipt number | R000060183 |
| Scientific Title | The study to verify the effect of combined consumption of Japanese sweets and beverages on postprandial blood sugar level. |
| Date of disclosure of the study information | 2023/11/09 |
| Last modified on | 2024/11/08 11:05:22 |
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Basic information
Public title
The study to verify the effect of combined consumption of Japanese sweets and beverages on postprandial blood sugar level.
Acronym
The study to verify the effect of combined consumption of Japanese sweets and beverages on postprandial blood sugar level.
Scientific Title
The study to verify the effect of combined consumption of Japanese sweets and beverages on postprandial blood sugar level.
Scientific Title:Acronym
The study to verify the effect of combined consumption of Japanese sweets and beverages on postprandial blood sugar level.
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 was to evaluate the effect of consuming yokan and various beverages on postprandial blood sugar levels in a human study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation is performed by measuring blood sugar levels before, 15, 30, 45, 60, 90, and 120 minutes after ingesting the test food.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drink glucose water.
Interventions/Control_2
Take yokan and water.
Interventions/Control_3
Take yokan and green tea1.
Interventions/Control_4
Take yokan and green tea2.
Interventions/Control_5
Have yokan and coffee.
Interventions/Control_6
Take yokan and guava leaf tea.
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
Persons affiliated with Doshisha University Department of Medical and Life Systems and Doshisha University Graduate School of Medical and Life Systems.
Key exclusion criteria
Persons currently suffering from some chronic disease and receiving pharmaceutical treatment.
Target sample size
20
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.doshisya.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.doshisya.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 Confectionary Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
AGE Lab Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Life and Medical Sciences,Doshisha Universit
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
Tel
0774-65-6394
yyonei@mail.doshisya.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
| 2023 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000060183
Publication of results
Published
Result
URL related to results and publications
https://www.toukastress.jp/webj/article/2024/GS24-15.pdf
Number of participants that the trial has enrolled
21
Results
A diet that involves ingesting both Yokan and beverages may lead to a reduction in glycative stress caused by blood glucose spikes.
Results date posted
| 2024 | Year | 11 | Month | 08 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 11 | Month | 09 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060183
