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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036758
Receipt No. R000041731
Scientific Title Study on effects of okra-containing food on blood pressure
Date of disclosure of the study information 2019/05/15
Last modified on 2019/05/18

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Basic information
Public title Study on effects of okra-containing food on blood pressure
Acronym Study on effects of okra-containing food on blood pressure
Scientific Title Study on effects of okra-containing food on blood pressure
Scientific Title:Acronym Study on effects of okra-containing food on blood pressure
Region
Japan

Condition
Condition Subjects with high-normal blood pressure
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the improvement effect of hypertension with continuous intake of okra-containing food for 12 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes systolic blood pressure, diastolic blood pressure
Key secondary outcomes Body weight, Waist length, Serum triglyceride, Serum cholesterol, Blood glucose level, AST, ALT, Gamma-GTP,
Total Bilirubin

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of okra-containing food for 12 weeks, and then intake of the placebo food for 12 weeks after 4 weeks washout periods.
Interventions/Control_2 Intake of the placebo food for 12 weeks, and then intake of okra-containing food for 12 weeks after 4 weeks washout periods.
Interventions/Control_3
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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Males and females equal to or more than 40 years and less than 70 years of age
2) Subjects with high normal blood pressure
3) Possible study volunteer to visit
4) Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria 1) Pregnant women or breast-feeding women
2) Subjects who have marked impairment of heart, liver, kidney, thyroid, and other diseases
3) Subjects who have a history of cardiovascular disease
4) Subjects who develop diabetes
5) Subjects who take medications that may affect this inspection
6) Subjects who regularly using foods such as specified health foods, functional display foods and supplements that may affect this inspection
7) Subjects who have food allergy against okra
8) Subjects who highly intake okra and/or okra products on a daily basis
9) Individual who was judged ineligibles by clinician in this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Nakano
Organization Kagoshima Immculate Heart University
Division name Department of Health and Nutrition, Faculty of Nursing and Nutrition
Zip code 895-0011
Address Amatatsu-cho Satsumasendai-city, Kagoshima, JAPAN
TEL 0996235311
Email nakano@jundai.k-junshin.ac.jp

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Nakano
Organization Kagoshima Immculate Heart University
Division name Department of Health and Nutrition, Faculty of Nursing and Nutrition
Zip code 895-0011
Address Amatatsu-cho Satsumasendai-city, Kagoshima, JAPAN
TEL 0996235311
Homepage URL
Email nakano@jundai.k-junshin.ac.jp

Sponsor
Institute Kagoshima Immculate Heart University
Institute
Department

Funding Source
Organization Ibusiki City Office
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kagoshima Immculate Heart University
Address Amatatsu-cho Satsumasendai-city, Kagoshima, JAPAN
Tel 0996235311
Email nakano@jundai.k-junshin.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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 15 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 05 Month 15 Day
Date of IRB
2019 Year 05 Month 15 Day
Anticipated trial start date
2019 Year 05 Month 15 Day
Last follow-up date
2020 Year 02 Month 29 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 05 Month 15 Day
Last modified on
2019 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041731

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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