UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Title of the study (Brief title)	Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Region	Japan

Condition
Condition	Healthy volunteers Hypertension
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effect of prune concentrate on blood pressure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Systolic blood pressure and diastolic blood pressure at baseline, 6 and 12 weeks.
Key secondary outcomes	FMD (flow mediated dilation), NOx, ADMA (asymmetric dimethylarginine), platelet aggregation test, thromboxane B2, urinary 8-isoprostane, MDA (malondialdehyde), urinary 8-OHdG (8-hydroxydeoxyguanosine), BAP (biological antioxident potential) test, high-sensitivity CRP, and intestinal flora (T-RFLP), at baseline and 12 weeks.

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
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects receive 18 g of prune concentrate 3 times per day for 12 weeks.
Interventions/Control_2	Subjects receive 18 g of placebo 3 times per day for 12 weeks.
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	High-normal blood pressure or grade I hypertension
Key exclusion criteria	1) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia 2) Taking drugs or functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) Fruit allergy 5) In pregnancy or nursing a child 6) Cardiac, renal, and/or hepatic dysfunction 7) History of severe disease and/or major surgery
Target sample size	20

Research contact person
Name of lead principal investigator	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Email	fumiko@hiroshima-u.ac.jp

Public contact
Name of contact person	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Homepage URL
Email	fumiko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	MIKI Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 27 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 14 Day
Last modified on	2017 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023312