Unique ID issued by UMIN | UMIN000042354 |
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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 |
Test on suppression effect of postprandial blood sodium concentration.
Salt reduction test
Test on suppression effect of postprandial blood sodium concentration.
Salt reduction test
Japan |
Healthy Adults
Clinical immunology | Not applicable |
Others
NO
To verify the suppressing effect of the test food on postprandial blood sodium concentration.
Efficacy
Blood sodium delta AUC
* Before ingestion, 30, 60, 90, and 120 minutes after ingestion.
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)
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
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.
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.
20 | years-old | <= |
65 | years-old | > |
Male
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.
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
30
1st name | Takamasa |
Middle name | |
Last name | Masuda |
Healthcare Systems Co., Ltd.
Research and Development Department
105-0004
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
masudat@hc-sys.jp
1st name | Takamasa |
Middle name | |
Last name | Masuda |
Healthcare Systems Co., Ltd.
Research and Development Department
105-0004
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
masudat@hc-sys.jp
Healthcare Systems Co., Ltd.
TOY MEDICAL Co., Ltd.
Profit organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
03-6809-2722
soumu@hc-sys.jp
NO
2020 | Year | 11 | Month | 05 | Day |
Unpublished
30
Completed
2020 | Year | 11 | Month | 05 | Day |
2020 | Year | 11 | Month | 05 | Day |
2020 | Year | 11 | Month | 14 | Day |
2020 | Year | 12 | Month | 13 | Day |
2020 | Year | 11 | Month | 05 | Day |
2021 | Year | 05 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048351
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