UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058638 |
|---|---|
| Receipt number | R000067055 |
| Scientific Title | The association between salivary amylase and blood glucose level after starch loading |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/07/29 20:06:04 |
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Basic information
Public title
The association between salivary amylase and blood glucose level after starch loading
Acronym
Salivary amylase and blood glucose level after starch loading
Scientific Title
The association between salivary amylase and blood glucose level after starch loading
Scientific Title:Acronym
Salivary amylase and blood glucose level after starch loading
Region
| Japan |
Condition
Condition
Glucose metabolism disorder, Diabetes
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Pneumology |
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose is to investigate the association between salivary amylase gene (AMY1) copy number variation and salivary amylase activity and glucose and lipid metabolism after starch loading.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the association between salivary amylase activity and glucose metabolism after starch loading in healthy young women.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Gene |
Interventions/Control_1
150 g of cooked rice is immediately ingested. Subsequently, blood glucose, HbA1c, insulin, glucagon, incretin (GLP-1, GIP), triglyceride and lipase, salivary amylase activity, serum amylase isoenzymes are measured before and after the rice loading. Additionally, salivary amylase gene (AMY1) copy number variation are assessed.
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants will be enrolled in the Japan Women's University during the study period and will fulfill both criteria 1) and 2).
1) Those who fulfill all the following conditions.
1. Women aged 20-29 years old
2. BMI less than 30kg/m2
3. No impaired glucose tolerance in the past year
4. No special eating habits (unbalanced vegetarianism, etc.) or excessive exercise habits
5. No smoking habits or excessive drinking habits
6. Those who were determined to be eligible for continuous blood sampling via antecubital vein using an indwelling needle, based on the results of a medical interview conducted by the principal investigator.
7. Those who have not been diagnosed with anemia in the past year
8. Those who are not allergic to heparin.
9. Those who do not have any diseases or are not taking any medications that may cause thrombosis.
10. Able to consume cooked rice
11. Able to self-measure blood glucose and undergo saliva sampling
12. Not taking medications for Sjogren's syndrome or that affect salivation
13. No problem with being asked about their blood type
2) Those who can understand the contents of this study after receiving an explanation of the study and have given their consent to participate in the study.
Key exclusion criteria
Those who do not fulfill the inclusion criteria 1)1-11 or 2) will be excluded. Additionally, those who are inappropriate by the study director and researchers will also be excluded (such as those with moderate to severe underlying diseases).
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Nakajima |
Organization
Japan Women's University
Division name
Dept. of Nutritional Science, Faculty of Food and Nutritional Sciences
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku
TEL
03-5981-3427
nakajimak@fc.jwu.ac.jp
Public contact
Name of contact person
| 1st name | Airi |
| Middle name | |
| Last name | Sekine |
Organization
Japan Women's University
Division name
Dept. of Nutritional Science, Faculty of Food and Nutritional Sciences
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku
TEL
03-5981-3427
Homepage URL
sekinea@fc.jwu.ac.jp
Sponsor or person
Institute
Japan Women's University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee for experimental research involving human subjects, Japan Women's University
Address
2-8-1, Mejirodai, Bunkyo-ku
Tel
03-5981-3775
n-shien@atlas.jwu.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 | 09 | Month | 01 | 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 | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067055
