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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000046640
Receipt No. R000053177
Scientific Title Study of the inhibitory effect on salt absorption by supplements intake
Date of disclosure of the study information 2022/01/14
Last modified on 2022/07/15

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Basic information
Public title Study of the inhibitory effect on salt absorption by supplements intake
Acronym Study of the inhibitory effect on salt absorption by supplements intake
Scientific Title Study of the inhibitory effect on salt absorption by supplements intake
Scientific Title:Acronym Study of the inhibitory effect on salt absorption by supplements intake
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the inhibitory effect on salt absorption for Japanese men (20 to 64 years old) when ingest the salt removal supplement for 4 days.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of urinary sodium
Key secondary outcomes Amount of urinary potassium and urinary creatinine

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingest 3 tablets of the test food in the first test and 3 tablets of placebo in the second test, 3 times a day for 4 days. Ingest the prescribed food during each intake period and the previous 3 days.
Interventions/Control_2 Ingest 3 tablets of placebo in the first test and 3 tablets of the test food in the second test, 3 times a day for 4 days. Ingest the prescribed food during each intake period and the previous 3 days.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male
Key inclusion criteria 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese who are 20 years old or more and under 65 years old
Key exclusion criteria 1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who have been diagnosed with hypertension by a doctor
3. Persons who are allergic to foods
4. Persons who regularly take large amounts of the test food
5. Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect the absorption or discharge of salt
6. Persons who have a drinking habit (more than 3 days a week, 1 go or more in terms of sake per drinking day)
7. Persons with a BMI of less than 18.5 or 30 or more
8. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
9. Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takamasa
Middle name
Last name Masuda
Organization Healthcare Systems Co., Ltd.
Division name Clinical Research Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email masudat@hc-sys.jp

Public contact
Name of contact person
1st name Takamasa
Middle name
Last name Masuda
Organization Healthcare Systems Co., Ltd.
Division name Clinical Research Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email masudat@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization TOY MEDICAL 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 The Ethics Committee of Healthcare Systems Co., Ltd.
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel 03-6809-2722
Email soumu@hc-sys.jp

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
2022 Year 01 Month 14 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 28
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
2022 Year 01 Month 07 Day
Date of IRB
2022 Year 01 Month 07 Day
Anticipated trial start date
2022 Year 02 Month 05 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 14 Day
Last modified on
2022 Year 07 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053177

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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