UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hypotensive effects of Umezu polyphenols among community-dwelling hypertensive patients not requiring medication
Title of the study (Brief title)	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	Shigeki Takemura
Organization	Wakayama Medical University
Division name	Department of Hygiene, School of Medicine
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	Shigeki Takemura
Organization	Wakayama Medical University
Division name	Department of Hygiene, School of Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 06 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-24790590/
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.
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