UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043853 |
|---|---|
| Receipt number | R000049985 |
| Scientific Title | Study on the effects of the intake of ingredients used in salads on the human's body |
| Date of disclosure of the study information | 2021/04/06 |
| Last modified on | 2021/06/23 11:54:43 |
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Basic information
Public title
Study on the effects of the intake of ingredients used in salads on the human's body
Acronym
Study on the effects of the intake of ingredients used in salads on the human's body
Scientific Title
Study on the effects of the intake of ingredients used in salads on the human's body
Scientific Title:Acronym
Study on the effects of the intake of ingredients used in salads on the human's body
Region
| Japan |
Condition
Condition
Poor blood circulation, Diabetes, Hypertension
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the intake of the ingredients used in a salad on the human body.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood sugar level, blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
10
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest 100 g of a sample prepared on the day using potato 1 (Nishiyutaka) once a day, and drink 200 ml of drinking water simultaneously.
Add mayonnaise using potato 1 (Nishiyutaka) Ingest 100 g of the sample prepared on the day of addition and drink 200 ml of drinking water simultaneously.
Interventions/Control_2
Ingest 100 g of a sample prepared using potato 1 (Nishiyutaka) and stored in a refrigerator for 2 days once a day, and drink 200 ml of drinking water simultaneously.
Prepared by adding mayonnaise using potato 1 (Nishiyutaka) and stored in a refrigerator for 2 days. Take 100 g of the sample once a day and drink 200 ml of drinking water simultaneously.
Interventions/Control_3
Ingest 100 g of a sample prepared on the day using potato 2 (Sayaka) once a day, and drink 200 ml of drinking water simultaneously.
Add mayonnaise using potato 2 (Sayaka) Ingest 100 g of the sample prepared on the day and drink 200 ml of drinking water simultaneously.
Interventions/Control_4
Ingest 100 g of a sample prepared using potato 1 (Nishiyutaka) and stored in a refrigerator for 2 days once a day, and drink 200 ml of drinking water simultaneously.
Prepare a sample prepared by adding mayonnaise using potato 1 (Nishiyutaka) and stored in a refrigerator for 2 days, ingest 100 g once a day, and drink 200 ml of drinking water at the same time.
Interventions/Control_5
The sample prepared using potato 3 (produced in Hokkaido) is ingested the next day (samples are stored refrigerated). Take 70g once a day and drink 200ml of drinking water at the same time.
Interventions/Control_6
Add mayonnaise using potato 3 (produced in Hokkaido) is ingested the next day (samples are stored refrigerated). Take 70g once a day and drink 200ml of drinking water at the same time.
Interventions/Control_7
Ingest a sample prepared using sweet potato 1 (produced in Ibaraki prefecture) the next day (samples are stored refrigerated). Take 70g once a day and drink 200ml of drinking water at the same time.
Interventions/Control_8
Add mayonnaise using sweet potato 1 (produced in Ibaraki prefecture) is ingested the next day (samples are stored refrigerated). Take 70g once a day and drink 200ml of drinking water at the same time.
Interventions/Control_9
Ginger sample 1: 100g of raw ground ginger added the drinking water of 100 g, and the solution filtered through sterile gauze was used as a ginger sample. Add 40 ml of drinking water to 10 ml of ginger solution and ingest 50 ml of the sample once a day.
Interventions/Control_10
Ginger sample 2: Add 40 ml of drinking water to 10 ml of ginger solution after heating sample 1 for 30 minutes using a pressure cooker, and ingest 50 ml of the sample once a day.
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
It is intended for healthy students aged 20 and over who are not allergic to the ingredients to be tested (especially those who do not have the medical condition declared) of Tokyo University of Marine Science and Technology.
Key exclusion criteria
People who are allergic to the ingredients to be tested, especially those who have a medical condition that can be declared
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo University of Marine Science and Technology
Division name
Office of Liaison and Cooperative research
Zip code
1088477
Address
4-5-7, Minato-ku, Tokyo
TEL
0354630587
toru@kaiyodai.ac.jp
Public contact
Name of contact person
| 1st name | Younju |
| Middle name | |
| Last name | Lee |
Organization
Tokyo University of Marine Science and Technology
Division name
Office of Liaison and Cooperative research
Zip code
1088477
Address
4-5-7, Minato-ku, Tokyo
TEL
0354630522
Homepage URL
ylee000@kaiyodai.ac.jp
Sponsor or person
Institute
Tokyo University of Marine Science and Technology
Institute
Department
Personal name
Funding Source
Organization
KENKO Mayonnaise Co., Ltd.
Japan Ginger Co., Ltd.
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2021 | Year | 04 | Month | 06 | 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
13
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 | 01 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049985
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