UMIN-CTR Clinical Trial

Basic information
Public title	Test on suppression effect of postprandial blood sodium concentration.
Acronym	Salt reduction test
Scientific Title	Test on suppression effect of postprandial blood sodium concentration.
Scientific Title:Acronym	Salt reduction test
Region	Japan

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

Objectives
Narrative objectives1	To verify the suppressing effect of the test food on postprandial blood sodium concentration.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood sodium delta AUC * Before ingestion, 30, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes	Total protein, albumin, neutral fat, total cholesterol, HDL-cholesterol, LDL-cholesterol, AST (GOT), ALT (GPT), ALP, gamma-GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, Blood levels of potassium, chlorine, calcium, iron, phosphorus, magnesium, LDH, hematocrit, blood osmotic pressure, renin activity, aldosterone. * Before ingestion, 30, 60, 90, and 120 minutes after ingestion. Postprandial urinary sodium, potassium, creatinine Blood pressure before and after ingestion (systolic blood pressure, diastolic blood pressure, pulse)

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 test food A * in the first test and 3 tablets of test food B * in the second test, together with salt-loaded foods. In the third test, ingest 3 tablets of salt excretion supplement without taking salt-loaded foods. *Test foods A and B are either salt excretion supplements or placebo.
Interventions/Control_2	Ingest 3 tablets of test food B * in the first test and 3 tablets of test food A * in the second test, together with salt-loaded foods. In the third test, ingest 3 tablets of salt excretion supplement without taking salt-loaded foods. *Test foods A and B are either salt excretion supplements or placebo.
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. 3. From persons who meet 2, preferentially select 30 persons with higher blood sodium delta AUC values at the time of screening, excluding those with outliers.
Key exclusion criteria	1. Persons who have chronic illness, receiving medication, have a serious disease history 2. Persons who are allergic to the test food 3. Persons who regularly use medicines, foods for specified health use, health foods, etc. that may affect the amount of salt intake 4. Persons who have a history of hospital visits for hypertension treatment 5. 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 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 who were judged as inappropriate for subjects 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	Research and Development 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	Research and Development 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	2020 Year 11 Month 05 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	30
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 11 Month 05 Day
Date of IRB	2020 Year 11 Month 05 Day
Anticipated trial start date	2020 Year 11 Month 14 Day
Last follow-up date	2020 Year 12 Month 13 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 11 Month 05 Day
Last modified on	2021 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048351