UMIN-CTR Clinical Trial

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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