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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020186
Receipt No. R000023312
Scientific Title Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Date of disclosure of the study information 2015/12/15
Last modified on 2017/06/15

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Basic information
Public title Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Acronym Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Scientific Title Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Scientific Title:Acronym 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
1st name
Middle name
Last name Fumiko Higashikawa
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Project Research Center for Clinical Trial and Preventive Medicine
Zip code
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
1st name
Middle name
Last name Fumiko Higashikawa
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Project Research Center for Clinical Trial and Preventive Medicine
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2015 Year 11 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023312

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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