UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052662 |
|---|---|
| Receipt number | R000060094 |
| Scientific Title | Effect of vegetable consumption with chewing on postprandial metabolism. |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2023/10/31 13:39:04 |
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Basic information
Public title
Effect of vegetable consumption with chewing on postprandial glucose metabolism in healthy young men.
Acronym
Effect of vegetable consumption with chewing on glucose metabolism in healthy young men.
Scientific Title
Effect of vegetable consumption with chewing on postprandial metabolism.
Scientific Title:Acronym
Effect of chewing on postprandial metabolism.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of chewing vegetables on postprandial glucose metabolism in healthy young men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose, Insulin, GLP-1, GIP
Key secondary outcomes
Anthropometry, subjective appetite, other blood parameters
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Consumption of shredded cabbage with chewing, followed by energy jelly, and measurement and evaluation of biochemical and hormonal markers by blood sampling over a period of 180 minutes after the meal.
Interventions/Control_2
Consumption of pureed cabbage without chewing, followed by energy jelly, and measurement and evaluation of biochemical and hormonal markers by blood sampling over a period of 180 minutes after the meal.
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
Male
Key inclusion criteria
- Not taking any medications and dietary supplements
- No chronic disease
- No smoker
- Body mass stable for at least 3 months before the study and not intention to lose weight during the study.
- No history of immediate allergic reaction to test meals.
- No participation in other studies during the conduct of this study.
Key exclusion criteria
- A participant who takes medications and dietary supplements
- A participant who has chronic disease
- Smoker
- Body mass not stable for at least 3 months before the study and intention to lose weight during the study.
- A participant who has history of immediate allergic reaction to test meals.
- Participation in other studies during the conduct of this study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima,Tokorozawa, Saitama
TEL
04-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima,Tokorozawa, Saitama
TEL
04-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Waseda University
Address
1-104 Totsuka-cho, shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2023 | Year | 10 | Month | 31 | 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
18
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
| 2021 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 11 | 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
| 2023 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060094
