UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041954 |
|---|---|
| Receipt number | 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 | 2021/09/29 13:04:57 |
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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
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
imai@levbrain.com
Sponsor or person
Institute
KAGOME CO., LTD
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047886
