UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036758 |
|---|---|
| Receipt number | 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 | 2021/05/17 10:18:20 |
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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
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
nakano@jundai.k-junshin.ac.jp
Sponsor or person
Institute
Kagoshima Immculate Heart University
Institute
Department
Personal name
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
kaz@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
No longer 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
| 2021 | Year | 03 | 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 | 05 | Month | 15 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041731
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
