UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029394
Receipt number 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 09:33:04

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.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