UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060341 |
|---|---|
| Receipt number | R000069032 |
| Scientific Title | Study on the effect of Japanese black tea extract in suppressing postprandial blood glucose and insulin levels (Randomized Crossover Trial) |
| Date of disclosure of the study information | 2026/01/13 |
| Last modified on | 2026/01/13 17:38:52 |
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Basic information
Public title
Study on the effect of Japanese black tea on suppressing postprandial blood glucose and insulin levels (Randomized Crossover Trial)
Acronym
Study on the effect of Japanese black tea on suppressing postprandial blood glucose and insulin levels (Randomized Crossover Trial)
Scientific Title
Study on the effect of Japanese black tea extract in suppressing postprandial blood glucose and insulin levels (Randomized Crossover Trial)
Scientific Title:Acronym
Study on the effect of Japanese black tea extract in suppressing postprandial blood glucose and insulin levels (Randomized Crossover Trial)
Region
| Japan |
Condition
Condition
Adult Men and Women with High Postprandial Blood Glucose Levels
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the inhibitory effect of Japanese black tea extract on postprandial blood glucose and insulin levels in adult men and women with high postprandial blood glucose levels in a randomized crossover trial.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Postprandial blood glucose levels and area under the curve
2. Postprandial blood insulin levels and area under the curve
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Test food intake - washout - placebo food intake
Interventions/Control_2
Placebo food intake - washout - Test food intake
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.A healthy young women
2.Subjects whose postprandial blood glucose peaks were higher than the median for all subjects.
Key exclusion criteria
1.Subjects with a history of diabetes
2.Subjects with fasting blood glucose levels of 126 mg/dL or higher
3.Subjects who regularly use medications, 'Food for Specified Health Uses', 'Foods with Functional Claims'that may affect blood glucose levels
4.Subjects who are pregnant or willing to be pregnant or breast-feeding during this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | Moto |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
272-8533
Address
2-3-1 konodai, Ichikawa, Chiba, Japan
TEL
047-371-2393
moto@wayo.ac.jp
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Moto |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
272-8533
Address
2-3-1 konodai, Ichikawa, Chiba, Japan
TEL
047-371-2393
Homepage URL
moto@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
Funding Source
Organization
Wayo 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
Wayo Women's University Research Support Division
Address
2-3-1 konodai, Ichikawa, Chiba, Japan
Tel
047-371-1184
k-shien@wayo.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
| 2026 | Year | 01 | Month | 13 | 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 | 12 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | 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
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069032
