Unique ID issued by UMIN | UMIN000030166 |
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Receipt number | R000034415 |
Scientific Title | Evaluation of postprandial salinity concentration in blood: a randomized, double-blind, placebo-controlled, crossover trial |
Date of disclosure of the study information | 2017/11/29 |
Last modified on | 2018/04/24 16:58:12 |
Evaluation of postprandial salinity concentration in blood: a randomized, double-blind, placebo-controlled, crossover trial
Evaluation of postprandial salinity concentration in blood
Evaluation of postprandial salinity concentration in blood: a randomized, double-blind, placebo-controlled, crossover trial
Evaluation of postprandial salinity concentration in blood
Japan |
Healthy Japanese adult people
Not applicable | Adult |
Others
NO
To verify the effects on postprandial salinity concentration in blood with the intake of the test food
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Area under curve (AUC) of sodium concentration (Na) in blood between before meal and 120 minutes after meal
* Take blood samples before eating the prescribed diet and at 30, 60, 90, and 120 minutes after meal (total 5 times).
1-1. Sodium (Na) concentration in blood
1-2. Iron (Fe) concentration in blood
1-3. Potassium (K) concentration in blood
1-4. Chloride (Cl) concentration in blood
1-5. Inorganic phosphate (IP) concentration in blood
2. systolic blood pressure, diastolic blood pressure, and pulse rate
*1 Take blood samples before eating the prescribed diet and at 30, 60, 90, and 120 minutes after meal (total 5 times). For 1-1, the blood sodium concentration is evaluated before meal and at 30, 60, 90, and 120 minutes after meal. For 1-2 ~ 1-5, the area under curve (AUC) is evaluated between before meal and 120 minutes after meal.
*2 Physical examination is conducted before eating the prescribed diet and at 30, 60, 90, and 120 minutes after meal (total 5 times).
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Food |
I. Salt excretion supplement
II. Placebo supplement
* The intervention sequence is I-II, and each food is single ingestion.
* Take 3 capsules before eating the prescribed diet (2 rice balls: the intake of sodium will be approximately 1750 mg).
* Eat the prescribed diet with a glass of water (280 ml).
*Washout period is for 1 week and more.
I. Placebo supplement
II. Salt excretion supplement
* The intervention sequence is I-II, and each food is single ingestion.
* Take 3 capsules before eating the prescribed diet (2 rice balls: the intake of sodium will be approximately 1750 mg).
* Eat the prescribed diet with a glass of water (280 ml).
* Washout period is for 1 week and more.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult people
2. Subjects who are judged as eligible to participate in the study by the principal investigator
3. Select the participants as equal as possible based on sodium concentration in blood at screening
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases
3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
4. Currently taking medicines (include herbal medicines) and supplements
5. Subjects who are allergic to medicines and/or the test food related products
6. Subjects who are pregnant, breast-feeding, and planning to become pregnant
7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
8. Subjects who are judged as ineligible to participate in the study by the principal investigator
16
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
TOY MEDICAL Co., Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2017 | Year | 11 | Month | 29 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 21 | Day |
2017 | Year | 11 | Month | 29 | Day |
2017 | Year | 11 | Month | 29 | Day |
2018 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034415
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