UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053152 |
|---|---|
| Receipt number | R000057645 |
| Scientific Title | Effect of mulberry and water chestnut husk in mixed tea consumption on postprandial blood glucose levels in young adults: a randomized, double-blind, placebo-controlled crossover trial |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2024/01/31 17:24:07 |
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Basic information
Public title
The relationship between intake of mulberry and water chestnut husk in mixed tea and postprandial blood glucose level in young people
Acronym
The relationship between intake of mulberry and water chestnut husk in mixed tea and postprandial blood glucose level in young people
Scientific Title
Effect of mulberry and water chestnut husk in mixed tea consumption on postprandial blood glucose levels in young adults: a randomized, double-blind, placebo-controlled crossover trial
Scientific Title:Acronym
Effect of mulberry and water chestnut husk in mixed tea consumption on postprandial blood glucose levels in young adults
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the effect of mulberry and water chestnut husk in mixed tea on postprandial blood glucose and the presence of the second meal effect in healthy young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in blood glucose levels between both groups after consumption of the first load food after drinking mulberry and water chestnut husk in mixed tea.
Key secondary outcomes
Difference in iAUC in interstitial fluid by FreeStyle Libree from the start of consumption of the first and second load food in both groups after drinking mulberry and water chestnut husk in mixed tea or placebo tea.
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of mulberry and water chestnut husk in mixed tea
Interventions/Control_2
Single ingestion of placebo tea
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy young adutlts with no physical, mental, or social difficulties.
2. Participants with a BMI of more than 16.0 kg/m2 or less than 23 kg/m2
3. Participants who understand the purpose and contents of the experiment
Key exclusion criteria
1. Participants with a fasting blood glucose level of 126 mg/dL or higher and hemoglobin A1c of 6.5% or higher
2. Participants with a BMI of less than 16 kg/m2 or greater than 23 kg/m2
3. Participants who routinely take medicines, health foods, or supplements that may affect the test results
4. Participants with implanted medical devices such as pacemakers
5. Participants who consume alcohol excessively
6. Participants who are allergic to some medicines and some foods
7. Participants who are pregnant or may be pregnant or who are breastfeeding
8. Participants with a current medical history, such as atopic dermatitis, who have concerns about wearing the FreeStyle Libre sensors
9. Participants who requested withdrawal from the research subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
8140198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
yasutake@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
8140198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
Homepage URL
yasutake@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Kenichiro Yasutake
Funding Source
Organization
Nakamura Gakuen 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
Cooperation Promotion Department, Nakamura Gakuen University
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
Tel
092-851-5579
kks@nakamura-u.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
中村学園大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | 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
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057645
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| Registered date | File name |
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