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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031648
Receipt No. R000025700
Scientific Title A Study onthe relationship between Na excretion and time of urine collection
Date of disclosure of the study information 2018/03/09
Last modified on 2018/11/21

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Basic information
Public title A Study onthe relationship between Na excretion and time of urine collection
Acronym A Study onthe relationship between Na excretion and time of urine collection
Scientific Title A Study onthe relationship between Na excretion and time of urine collection
Scientific Title:Acronym A Study onthe relationship between Na excretion and time of urine collection
Region
Japan

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

Objectives
Narrative objectives1 Investigate the time ingested salt is discharged in the urine as Na excretion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes urinay Na, K, Cr, Na/K, Na/Cr
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Commercial refrigeration lunch and seasoing, pickles.
Interventions/Control_2
Interventions/Control_3
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
18 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria Healthy male and female of less than 18 or more 30-year-old (nutrition undergraduate college students, graduate students, research staff)
Key exclusion criteria smoker, dosage or Diabetes, dyslipidemia, abnormal liver function, renal function abnormalities, such as, a subject having a disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wao Tsutsui
Organization Kobe Gakuin University
Division name Faculty of Nutrition
Zip code
Address 518 Arise, ikawadani-cho, Nishi-ku, Kobe 651-2180
TEL 078-974-1551
Email tsutsuiwao@nutr.kobegakuin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wao Tsutsui
Organization Kobe Gakuin University
Division name Faculty of Nutrition
Zip code
Address 518 Arise, ikawadani-cho, Nishi-ku, Kobe 651-2180
TEL 078-974-1551
Homepage URL
Email tsutsuiwao@nutr.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin University
Institute
Department

Funding Source
Organization Kobe Gakuin University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 09 Day
Last modified on
2018 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025700

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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