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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029394
Receipt No. R000033484
Scientific Title Hypotensive effects of Umezu polyphenols among community-dwelling hypertensive patients not requiring medication
Date of disclosure of the study information 2017/10/03
Last modified on 2017/10/03

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Basic information
Public title Hypotensive effects of Umezu polyphenols among community-dwelling hypertensive patients not requiring medication
Acronym Hypotensive effects of Umezu polyphenols
Scientific Title Hypotensive effects of Umezu polyphenols among community-dwelling hypertensive patients not requiring medication
Scientific Title:Acronym Hypotensive effects of Umezu polyphenols
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate hypotensive effects of Umezu polyphenols.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decrease of systolic blood pressure and diastolic blood pressure after 12 weeks of intake of Umezu polyphenols in
(1) blood pressure at home, and
(2) blood pressure at the examination site
Key secondary outcomes Findings from blood tests (hematology and biochemistry)
Anthropometric factors
Self-perceived physical and mental health status evaluated with SF-8
Self-perceived Symptoms
Changes in data of annual health checkups

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Four capsules containing Umezu polyphenols (200 mg per capsule) daily for 12 weeks, followed by 2 weeks of wash-out period and 12 months of follow-up period with mail surveys every 3 months.
Interventions/Control_2 Four placebo capsules daily for 12 weeks, followed by 2 weeks of wash-out period and 12 months of follow-up period with mail surveys every 3 months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria People with high-normal blood pressure (systolic blood pressure (SBP), 130-139 mmHg; or diastolic blood pressure (DBP), 85-89 mmHg) or low- and moderate-risk grade I hypertension (SBP, 140-159 mmHg; or DBP, 90-99 mmHg) at the clinic, taking no antihypertensive agents.
(Recruited from people living in or working for a corporation in Minabe Town, Wakayama Prefecture, Japan, pursuant to Guidelines for the Management of Hypertension JSH 2009, published by the Japanese Society of Hypertension.)
Key exclusion criteria (1) People who eat two or more Umeboshi (pickled plums) per day regularly, (2) people with ingestion difficulty, (3) people with history of serious chronic conditions including cerebrovascular disease, ischemic heart disease and cancer (malignant tumor), (4) people under medication for hypertension, (5) people who are pregnant or within 1 year after delivery, (6) people having night-shift work with night duty, (7) people who cannot participate in follow-up blood pressure measurements, and (8) people whose participation is judged to be inappropriate due to any other reason by the responsible physician.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Takemura
Organization Wakayama Medical University
Division name Department of Hygiene, School of Medicine
Zip code
Address 811-1, Kimiidera, Wakayama, 641-8509, Japan
TEL +81-(0)73-441-0646
Email steakmmi@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Takemura
Organization Wakayama Medical University
Division name Department of Hygiene, School of Medicine
Zip code
Address 811-1, Kimiidera, Wakayama, 641-8509, Japan
TEL +81-(0)73-441-0646
Homepage URL
Email steakmmi@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Kindai University
Wakayama Industry Promotion Foundation
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 和歌山県立医科大学(和歌山県) (Wakayama Medical University (Wakayama Prefecture))

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-24790590/
Number of participants that the trial has enrolled
Results
Some potential effects of Umezu polyphenols to prevent blood pressure elevation and to improve self-perceived physical health were observed. After withdrawal of Umezu polyphenols, this self-perceived physical health gradually returned to the initial level within one year.
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 Main results already published
Date of protocol fixation
2013 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 11 Day
Last follow-up date
2015 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
2017 Year 10 Month 03 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033484

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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