Unique ID issued by UMIN | UMIN000030411 |
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Receipt number | R000034652 |
Scientific Title | The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers |
Date of disclosure of the study information | 2019/04/01 |
Last modified on | 2019/10/24 09:20:51 |
The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers
The effect of test food on night-time urinary electrolyte excretion in healthy volunteers
The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers
The effect of test food on night-time urinary electrolyte excretion in healthy volunteers
Japan |
Healthy Volunteer
Adult |
Others
NO
To examine the effect of test food on urinary electrolyte excretion
Efficacy
Urinary electrolyte
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Placebo(single ingestion) - washout period - test food(single ingestion)
Test food(single ingestion) - washout period - Placebo(single ingestion)
30 | years-old | <= |
65 | years-old | > |
Male and Female
1)Healthy males aged between 30 and 64. Healthy post-menopausal females aged between 50 and 64 with no menstruation in the past 12 months.
2)Subjects who 24hr Urinary sodium in screening examination is lower.
3)Subjects who routinely not take medicine, supplements, FOSHU, and/or health food which affect to the result of the study.
1) Subjects who have allergy to medicinal and foods.
2) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease).
3) Subjects who systolic blood pressure is more than 140 mmHg or diastolic blood pressure is more than 90 mmHg.
4) Subjects who BMI is more than 30 kg/m2.
5) Subjects who make a blood donation of 400 ml within 12 weeks before the start of the intake or that of 200 ml within 4 weeks before the start of the intake.
6) Subjects who are estimated inappropriate to participate to this study by principal investigator.
20
1st name | |
Middle name | |
Last name | Tsuneyuki Noda |
Otsuka Pharmaceutical Co., Ltd.
Saga Nutraceuticals Research Institute
5006-5 Yoshinogari, Kanzaki, Saga
0952-52-1522
Noda.Tsuneyuki@otsuka.jp
1st name | |
Middle name | |
Last name | Tsuneyuki Noda |
Otsuka Pharmaceutical Co., Ltd.
Saga Nutraceuticals Research Institute
5006-5 Yoshinogari, Kanzaki, Saga
0952-52-1522
Noda.Tsuneyuki@otsuka.jp
Otsuka Pharmaceutical Co., Ltd
Otsuka Pharmaceutical Co., Ltd
Profit organization
NO
大塚製薬株式会社 佐賀栄養製品研究所 (佐賀県)
2019 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 07 | Day |
2017 | Year | 11 | Month | 07 | Day |
2017 | Year | 12 | Month | 16 | Day |
2018 | Year | 03 | Month | 25 | Day |
2017 | Year | 12 | Month | 15 | Day |
2019 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034652
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