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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038270
Receipt No. 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

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Basic information
Public title Study on effects of Luffa cylindrica intake by different cooking methods on blood pressure
Acronym Effects of Luffa cylindrica intake on blood pressure
Scientific Title Study on effects of Luffa cylindrica intake by different cooking methods on blood pressure
Scientific Title:Acronym Effects of Luffa cylindrica intake on blood pressure
Region
Japan

Condition
Condition Subjects with high normal blood pressure or grade 1 hypertension
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of 12 weeks continuous intake of Luffa cylindrica by different cooking method on blood pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes homoe blood pressure (Systolic blood pressure and Diatolic blood pressure)
Key secondary outcomes blood pressure, heart rate, body weight, urinary sodium and pottasium, defecation status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of 200mL Luffa smoothie made by steaming (everyday for 12 weeks)
Interventions/Control_2 Intake of 200mL Luffa smoothie made by boiling (everyday for 12 weeks)
Interventions/Control_3 intake of 200mL placebo smoothie (everyday for 12 weeks)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Ohya
Organization Graduate school of medicine, University of the Ryukyus
Division name Depertment of Cardiovascular Medicine, Nephrology and Neurology
Zip code 903-0215
Address 207 Uehara, Nishihara-cho, Okinawa, Japan
TEL 098-895-1148
Email ohya@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name Hidemi
Middle name
Last name Todoriki
Organization University of the Ryukyus
Division name Tropical Biosphere Research Center
Zip code 903-0213
Address 1 Senbaru, Nishihara-cho, Okinawa, Japan
TEL 098-895-8549
Homepage URL
Email todoriki@comb.u-ryukyu.ac.jp

Sponsor
Institute Unicersity of the Ryukyus
Institute
Department

Funding Source
Organization National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics committiees of University of the Ryukyus
Address 1 Senbaru, Nishihara-cho, Okinawa, Japan
Tel 098-895-8016
Email knknkyu@acs.u-ryukyu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 琉球大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 07 Month 10 Day
Date of IRB
2019 Year 07 Month 10 Day
Anticipated trial start date
2019 Year 10 Month 12 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 11 Day
Last modified on
2020 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041529

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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