Unique ID issued by UMIN | UMIN000038270 |
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Receipt number | R000041529 |
Scientific Title | Study on effects of Luffa cylindrica intake by different cooking methods on blood pressure |
Date of disclosure of the study information | 2019/10/11 |
Last modified on | 2020/10/13 12:02:43 |
Study on effects of Luffa cylindrica intake by different cooking methods on blood pressure
Effects of Luffa cylindrica intake on blood pressure
Study on effects of Luffa cylindrica intake by different cooking methods on blood pressure
Effects of Luffa cylindrica intake on blood pressure
Japan |
Subjects with high normal blood pressure or grade 1 hypertension
Not applicable | Adult |
Others
NO
To investigate the effect of 12 weeks continuous intake of Luffa cylindrica by different cooking method on blood pressure
Efficacy
Confirmatory
Explanatory
Not applicable
homoe blood pressure (Systolic blood pressure and Diatolic blood pressure)
blood pressure, heart rate, body weight, urinary sodium and pottasium, defecation status
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
3
Prevention
Food |
Intake of 200mL Luffa smoothie made by steaming (everyday for 12 weeks)
Intake of 200mL Luffa smoothie made by boiling (everyday for 12 weeks)
intake of 200mL placebo smoothie (everyday for 12 weeks)
30 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Subjects with BMI above 20 kg/m2-under 30 kg/m2
2) Subjects with high normal blood pressure (Systolic BP from 130 to 139 mmHg and/or diastolic blood pressure from 85-89 mmHg) or grade1 hypertension (Systolic BP from 140 to 159 mmHg and/or diastolic blood pressure from 90-99 mmHg)
3) Subjects who can receive sufficient explanation, understand the contents, and hand in written consent by the person
1) Subjects who regularly consume medicines, food for specified health use, health food, etc. that may affect the test results.
2) Subjects who are currently on a diet or are planning a diet.
3) Subjects who plan to travel for a long time during the examination period.
4) Alcoholic drinkers (Alcohol intake 60 g / day or more).
5) Subjects who have irregular diets, irregular shift rhythms, shift workers, late-night workers.
6) Subjects who have a history of serious diseases such as heart, liver, kidney, digestive system etc.
7) Subjects who are pregnant, planning pregnancy or nursing.
8) Subjects who are participating in clinical trials of other medicines or health food, within 4 weeks after the end of the trial, or who are planning to participate in other clinical trials after consenting to participate in the trial.
9) Subjects who are continuing treatment with drugs.
10) Subjects who are allergic to medicines or food (especially Luffa).
11) Subjects who performed component blood donation or blood donation of 200mL of whole blood from the month before the start of the trial.
12) Men who performed blood donation of 400mL whole blood three months before the start of the trail.
13) Women who performed blood donation of 400mL whole blood four months before the start of the trial.
14) Subjects who was judged by the study principal physician or the trial division physician to be inappropriate to participate in this trial.
180
1st name | Yusuke |
Middle name | |
Last name | Ohya |
Graduate school of medicine, University of the Ryukyus
Depertment of Cardiovascular Medicine, Nephrology and Neurology
903-0215
207 Uehara, Nishihara-cho, Okinawa, Japan
098-895-1148
ohya@med.u-ryukyu.ac.jp
1st name | Hidemi |
Middle name | |
Last name | Todoriki |
University of the Ryukyus
Tropical Biosphere Research Center
903-0213
1 Senbaru, Nishihara-cho, Okinawa, Japan
098-895-8549
todoriki@comb.u-ryukyu.ac.jp
Unicersity of the Ryukyus
National Agriculture and Food Research Organization
Japanese Governmental office
Research Ethics committiees of University of the Ryukyus
1 Senbaru, Nishihara-cho, Okinawa, Japan
098-895-8016
knknkyu@acs.u-ryukyu.ac.jp
NO
琉球大学医学部附属病院
2019 | Year | 10 | Month | 11 | Day |
Unpublished
Open public recruiting
2019 | Year | 07 | Month | 10 | Day |
2019 | Year | 07 | Month | 10 | Day |
2019 | Year | 10 | Month | 12 | Day |
2021 | Year | 05 | Month | 31 | Day |
2019 | Year | 10 | Month | 11 | Day |
2020 | Year | 10 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041529
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