UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000053177