Unique ID issued by UMIN | UMIN000036575 |
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Receipt number | R000041672 |
Scientific Title | Effects of intake of the lemon juice on blood pressure: a randomized, double-blind, placebo-controlled, crossover trial |
Date of disclosure of the study information | 2019/12/29 |
Last modified on | 2021/05/31 10:01:49 |
A verification study for hypotensive effects of the test beverage
A verification study for hypotensive effects of the test beverage
Effects of intake of the lemon juice on blood pressure: a randomized, double-blind, placebo-controlled, crossover trial
Effects of intake of the lemon juice on blood pressure
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of 12-week-consumption of the test beverage on blood pressure.
Efficacy
Confirmatory
Pragmatic
Not applicable
Systolic blood pressure
* Assess the measured value at screening (before consumption), at 4, 8, and 12 weeks after consumption, and follow-up period for 4 weeks or calculate the amount of change.
Diastolic blood pressure
* Assess the measured value at screening (before consumption), at 4, 8, and 12 weeks after consumption, and follow-up period for 4 weeks or calculate the amount of change.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: 12 weeks
Follow-up duration: 4 weeks
Test beverage: Lemon juice containing beverage
Administration: Drink 30 mL of the test beverage per day at any time of the day
Duration: 12 weeks
Follow-up duration: 4 weeks
Test food: Placebo beverage
Administration: Drink 30 mL of the test beverage per day at any time of the day
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who are judged as eligible to participate in the study by the physician
3. Subjects whose diastolic pressure is less than 90 mmHg at screening (before consumption)
4. Subjects whose systolic blood pressure is 130 mmHg or more and 139 mmHg or less at screening (before consumption)
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, gastrointestinal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have severe anemia
5. Subjects who have or are suspected to have secondary hypertension
6. Subjects who drink alcoholic beverages or smoke cigars immoderately
7. Subjects who work late-night shift or are irregular of their life-styles
8. Subjects who have vigorous exercise habits
9. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
10. Subjects who are currently taking medications (including herbal medicines) and supplements
11. Subjects who are allergic to citrus fruits
12. Subjects who are allergic to medicines and/or the test food related products
13. Subjects who are pregnant, lactation, or planning to become pregnant
14. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period
15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
140
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | SUZUKI |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
SAPPORO HOLDINGS LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@takara-clinic.com
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)
2019 | Year | 12 | Month | 29 | Day |
Unpublished
154
Completed
2019 | Year | 04 | Month | 02 | Day |
2019 | Year | 04 | Month | 02 | Day |
2019 | Year | 04 | Month | 09 | Day |
2019 | Year | 11 | Month | 30 | Day |
2019 | Year | 04 | Month | 22 | Day |
2021 | Year | 05 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041672
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