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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043853
Receipt No. 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 2021/04/06

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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.
Interventions/Control_2 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_3 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.
Interventions/Control_4 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_5 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.
Interventions/Control_6 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_7 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.
Interventions/Control_8 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_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 13

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
Email 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
Email ylee000@kaiyodai.ac.jp

Sponsor
Institute Tokyo University of Marine Science and Technology
Institute
Department

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
Email 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 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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