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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023184
Receipt No. R000026727
Scientific Title Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study
Date of disclosure of the study information 2016/07/15
Last modified on 2017/05/30

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Basic information
Public title Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study
Acronym Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure
Scientific Title Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study
Scientific Title:Acronym Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical usefulness of 12-weeks ingestion of plum extract on the improvement of blood pressure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes systolic pressure and diastolic pressure at 4 weeks, 8 weeks and 12 weeks after the beginning of ingestion of test meals and at 2 weeks after the end of ingestion of test meals
Key secondary outcomes peripheral blood flow, TC, HDL-C, LDL-C, TG, fasting plasma glucose, HbA1c, platelet aggregation, defecation frequency, VAS questionnaire

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 YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of the plum extract-processed food (30 g) daily for 12 weeks
Interventions/Control_2 Ingestion of the placebo food (30 g) daily 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
30 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects whose hospital SBP is >=130 mmHg and <160 mmHg.
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria 1. Subjects who are under treatment and medication for hypertension.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities.
3. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with unusually high and/or low blood pressure or abnormal hematological data
5. Subjects with serious anemia.
6. Pre- or post-menopausal subjects having complaints of obvious physical changes.
7. Subjects who are at risk of having allergic reactions to drugs or foods (especially plum, fruits of the family Rosacea and/or white birch pollen).
8. Subjects regularly take medicine, functional foods and/or supplements (peptide, acetic acid, GABA, geniposidic acid, flavonoids, sesamin, chlorella, olive leaves, garlics, dietary fiber, tomatoes, folic acid, long pepper extract, etc.) which would affect the blood pressure.
9. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
10. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
11. Subjects who are pregnant or expected to be pregnant, or lactating during the study.
12. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
13. Any other medical reasons judged by the principal investigator.
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Center of Health Information Science
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization NAKANO.B.C. Co. Ltd.
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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 07 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
2016 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 28 Day
Last follow-up date
2016 Year 12 Month 10 Day
Date of closure to data entry
2017 Year 01 Month 25 Day
Date trial data considered complete
2017 Year 02 Month 01 Day
Date analysis concluded
2017 Year 04 Month 19 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 15 Day
Last modified on
2017 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026727

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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