UMIN-CTR Clinical Trial

Basic information
Public title	Study on the absorption and urinary excretion of minerals from vegetable juices
Acronym	Study on the absorption and urinary excretion of minerals from vegetable juices
Scientific Title	Study on the absorption and urinary excretion of minerals from vegetable juices
Scientific Title:Acronym	Study on the absorption and urinary excretion of minerals from vegetable juices
Region	Japan

Condition
Condition	healthy
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Understanding the effect of vegetable juice intake on the urinary sodium/potassium ratio
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	urinary sodium/potassium ratio
Key secondary outcomes	Salt intake estimates

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of tomato-containing vegetable juice (7 days) > Washout (3 days) > Intake of concentrated vegetable juice (7 days) > Washout (3 days) > Intake of vegetable juice (7 days)
Interventions/Control_2	Intake of concentrated vegetable juice (7 days) > Washout (3 days) > Intake of vegetable juice (7 days) > Washout (3 days) > Intake of tomato-containing vegetable juice (7 days)
Interventions/Control_3	Intake of vegetable juice (7 days) > Washout (3 days) > Intake of tomato-containing vegetable juice (7 days) > Washout (3 days) >Intake of concentrated vegetable juice (7 days)
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy Japanese men or postmenopausal Japanese women, the ages of more than 20 years old and less than 65 years old 2) Subjects who can fill out a web survey with a smartphone or iPhone 3) Subjects who get the sufficient explanation of the purpose and content of this study, have the ability to consent, voluntarily apply with the sufficient understanding, and approve of the participation in the document
Key exclusion criteria	1) Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases/disorders 2) Subjects who have diseases/disorders with continuous medical treatment or have medical history of severe diseases/disorders needed medical treatment 3) Subjects who receive medical treatment for digestive diseases/disorders which affect this study, or have surgical history of digestive system (except appendectomy) 4) Subjects with food allergies to ingredients in vegetable juices used in this study 5) Subjects who have received dietary guidance on potassium from a doctor or nutritionist 6) Subjects who habitually drink vegetable juices at least three times a week 7) Subjects who have been watching salt reduction and prefer a lighter taste 8) Any candidate considered to be unsuitable for enrollment based on his/her answers of lifestyle questionnaire 9) Subjects who had participated in other clinical trials including drug and food within 1 month 10) Subjects who are judged as inappropriate by investigators
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Ushida
Organization	KAGOME CO., LTD.
Division name	Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara-shi, Tochigi, Japan
TEL	0287-36-2935
Email	Yusuke_Ushida@kagome.co.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Imai
Organization	Leverage Brain Inc.
Division name	Clinical Trial Department
Zip code	105-0004
Address	2-16-1 Shinbashi Minato-ku, Tokyo, Japan
TEL	080-7290-0404
Homepage URL
Email	imai@levbrain.com

Sponsor
Institute	KAGOME CO., LTD
Institute
Department

Funding Source
Organization	KAGOME 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	Japan Conference of Clinical Research (JCCR)
Address	1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	03-6868-7022
Email	jccr-info@cts-smo.com

Secondary IDs
Secondary IDs	YES
Study ID_1	2020-R12
Org. issuing International ID_1	The Ethics Committee of KAGOME CO., LTD.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 01 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	2020 Year 09 Month 30 Day
Date of IRB	2020 Year 09 Month 30 Day
Anticipated trial start date	2020 Year 10 Month 02 Day
Last follow-up date	2020 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 30 Day
Last modified on	2021 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047886