Unique ID issued by UMIN | UMIN000053034 |
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Receipt number | R000060508 |
Scientific Title | A study of the effects of test food on Blood pressure lowering function -A randomized, double-blind, placebo-controlled, parallel study |
Date of disclosure of the study information | 2023/12/11 |
Last modified on | 2023/12/08 17:32:49 |
A study of the effects of test food on Blood pressure lowering function -A randomized, double-blind, placebo-controlled, parallel study
A study of the effects on Blood pressure lowering function
A study of the effects of test food on Blood pressure lowering function -A randomized, double-blind, placebo-controlled, parallel study
A study of the effects on Blood pressure lowering function
Japan |
normal high blood pressure subjects
Adult |
Others
NO
Verifying the effect of ingesting the test food on blood pressure lowering function
Efficacy
Assessment of systolic and diastolic blood pressure and blood flow-related subjective symptoms
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
2
Treatment
Food |
Oral intake of the test foods (1 capsules in a day for 12 weeks)
Oral intake of the placebo foods (1 capsules in a day for 12 weeks)
18 | years-old | <= |
65 | years-old | > |
Male and Female
1) normal high blood pressure subjects (systolic blood pressure 130-139 mmHg or diastolic blood pressure 85-89 mmHg, based on ambulatory blood pressure)
2) Healthy adults aged 18 to 65 years old.
3) Gender: No preference
4) Subjects without smoking habits
5) Subjects who do not have a habit of taking a meal containing a large amount of the tested food
6) Subjects who do not suffer from lifestyle diseases (high blood pressure, diabetes etc.), rheumatism, liver disorders, renal disorders, other chronic diseases
7) Subjects who have no history of treatment of malignant tumor, heart failure, myocardial infarction
8) Subjects who have no history of allergy to test foods / medicines
9) Subjects who do not take medication for Outpatient treatment
10) Subjects who do not regularly use health foods
11) Subjects giving written informed consent
1) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
2) Subjects who are participating the other clinical tests. Subjects who participated within 3-month prior to the current study
3) Subjects who do not comply with instructions from the doctor or medical staff
4) Others who have been determined ineligible by investigator
80
1st name | Naotaka |
Middle name | |
Last name | Hashiya |
Kanyukai clinic
Head
553- 0004
2-12-24 Tamagawa Fukushima-ku,Osaka-shi,Osaka,553-0004,Japan
06-6444-7788
hashiya@carna-medsalon.jp
1st name | Taisuke |
Middle name | |
Last name | Fukaya |
Tashikani Plus Co., Ltd
CEO
530-0041
6F 2-2-27 Tenjinbashi Kita-ku,Osaka-shi,Osaka,530-0041,Japan
06-6352-6622
fukaya@tashikani.jp
Tashikani Plus Co., Ltd
non-disclosure
Profit organization
Japan Food Evidence Association
7F 2-2-27 Tenjinbashi,Kita-ku,Osaka,530-0041,Japan
06-6352-6622
info@food-evidence.jp
NO
2023 | Year | 12 | Month | 11 | Day |
Unpublished
Preinitiation
2023 | Year | 11 | Month | 17 | Day |
2023 | Year | 12 | Month | 01 | Day |
2023 | Year | 12 | Month | 15 | Day |
2024 | Year | 06 | Month | 30 | Day |
2023 | Year | 12 | Month | 08 | Day |
2023 | Year | 12 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060508
Research Plan | |
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Research case data specifications | |
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