UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042354
Receipt number R000048351
Scientific Title Test on suppression effect of postprandial blood sodium concentration.
Date of disclosure of the study information 2020/11/05
Last modified on 2021/05/07 14:18:41

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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 or person

Institute

Healthcare Systems Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name