UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055504 |
|---|---|
| Receipt number | R000063425 |
| Scientific Title | The effect of co-ingesting rice and liquid on glycemic response and gastric emptying in healthy subjects |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/17 21:27:25 |
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Basic information
Public title
Examination of the effects of eating white rice combination with liquid(tea) on digestive (gastric motility) function and blood glucose levels
Acronym
Examination of the effects of eating white rice combination with liquid(tea) on digestive (gastric motility) function and blood glucose levels
Scientific Title
The effect of co-ingesting rice and liquid on glycemic response and gastric emptying in healthy subjects
Scientific Title:Acronym
The effect of co-ingesting rice and liquid on glycemic response and gastric emptying in healthy subjects
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Gastric emptying rate is closely correlated with postprandial glycemic response. However, the effects of combining carbohydrates with liquid on gastric emptying and glycemic response are complicated. We investigate the effect of co-ingesting rice and liquid in different ways on gastric emptying and glycemic response in healthy subjects.
Basic objectives2
Others
Basic objectives -Others
We investigated the effect of co-ingesting rice and liquid (green tea) on glycemic response and gastric emptying in healthy young subjects
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We perform a randomized crossover study in 12 healthy females. Three types of test meal are prepared: 150 g white rice (rice), 150 g white rice served alongside 200 mL of green tea (rice + tea), and 150 g white rice with 100 mL green tea poured over and served alongside 100 mL green tea (blend). After eating the test meal, measurements of postprandial glucose are performed, and breath samples for gastric emptying evaluation using (1-13C)-labeled sodium acetate breath test are collected for 120 min.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
150 g white rice only
Interventions/Control_2
150 g white rice serves alongside 200 mL of green tea
Interventions/Control_3
150 g white rice with 100 mL green tea poured over and serves alongside 100 mL green tea
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Young, healthy, non-pregnant Japanese females aged 18-29 years with a body mass index (BMI) less than 25 kg/m2. All participants have a blood pressure < 120/80 mmHg.
In addition, all participants are nonsmokers, had no food allergies, are not on any medication, and have no history of gastrointestinal tract, cardiovascular, or metabolic diseases.
Key exclusion criteria
Persons with food allergies, persons receiving medication in hospital, etc., or persons who have a smoking habit.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Matsunaga |
Organization
Mukogawa Women's University
Division name
Department of Food Science and Nutrition
Zip code
663-8558
Address
6-46 Ikebiraki-cho, Nishinomiya, Hyogo
TEL
+81-798-45-9804
matsu12@mukogawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Matsunaga |
Organization
Mukogawa Women's University
Division name
Department of Food Science and Nutrition
Zip code
663-8558
Address
6-46 Ikebiraki-cho, Nishinomiya, Hyogo
TEL
+81-798-45-9804
Homepage URL
matsu12@mukogawa-u.ac.jp
Sponsor or person
Institute
Mukogawa Women's University
Institute
Department
Personal name
Funding Source
Organization
Mukogawa Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mukogawa Women's University
Address
6-46 Ikebiraki-cho, Nishinomiya, Hyogo
Tel
+81-798-45-3575
sienka@mukogawa-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delayed due to confirmation of final data analysis
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
| 2021 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2022 | 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
| 2024 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063425
