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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041954
Receipt No. R000047886
Scientific Title Study on the absorption and urinary excretion of minerals from vegetable juices
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/30

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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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 30 Day
Date of IRB
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
2020 Year 09 Month 30 Day


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

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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