UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049410 |
|---|---|
| Receipt number | R000056260 |
| Scientific Title | Effect of Iwatsu Negi on bowel movements and digestion and absorption of carbohydrates and lipids |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2023/05/03 09:47:46 |
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Basic information
Public title
Effect of Iwatsu Negi on bowel movements and digestion and absorption of carbohydrates and lipids
Acronym
Effect of Iwatsu Negi on bowel movements and digestion and absorption of carbohydrates and lipids
Scientific Title
Effect of Iwatsu Negi on bowel movements and digestion and absorption of carbohydrates and lipids
Scientific Title:Acronym
Effect of Iwatsu Negi on bowel movements and digestion and absorption of carbohydrates and lipids
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of Iwatsu green onions on improving bowel movements and suppressing absorption of carbohydrates and fats
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Defecation frequency
2. Blood glucose concentration
3.Blood triglyceride concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 2 packets (5g) of Iwatsu green onion-containing food Negi no Chikara for 14 days
Bread (containing 30g carbohydrates) on day 14
Interventions/Control_2
Intake of 2 packets (5g) of placebo food without Iwatsu green onion for 14 days
Bread (containing 30g carbohydrates) on day 14
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
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Age 20-30, female, 40, university student, able-bodied
Key exclusion criteria
(1) Subjects with serious diseases (diabetes, heart disease, cancer, etc.) or mental illness.
(2) Subjects with a history of serious diseases (diabetes, heart disease, liver disease, renal disease, cancer, etc.) in the past.
(3) Subjects who have symptoms of severe anemia.
(4) Subjects who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity.
(5) Subjects with possible food or drug allergies to the test foods.
(6) Subjects who consume food for specified health use, health food, etc. on a daily basis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Matsuura |
Organization
Mukogawa Women's University
Division name
Department of Innovative Food Sciences
Zip code
6638558
Address
6-46, Ikebiraki-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-9884
toshikim@mukogawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Matsuura |
Organization
Mukogawa Women's University
Division name
Department of Innovative Food Sciences
Zip code
6638558
Address
6-46, Ikebiraki-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-9884
Homepage URL
toshikim@mukogawa-u.ac.jp
Sponsor or person
Institute
Mukogawa Women's University
Institute
Department
Personal name
Funding Source
Organization
MIRAI Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mukogawa Women's University Ethics Committee
Address
6-46, Ikebiraki-cho, Nishinomiya, Hyogo, Japan
Tel
0798-47-1212
somuk@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
武庫川女子大学 食物栄養科学部
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 02 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056260
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| Registered date | File name |
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