UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure and Blood Flow
Title of the study (Brief title)	The Effect of Daily Ingestion of the Plum Extract on the improvement of Blood Pressure and Blood Flow
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To prove the clinical usefulness of blood pressure and blood flow improvement by investigating effects from daily ingestion of plum extract for 12 weeks. To evaluate the overall health promotion by secondarily examining effects of lipid metabolism, blood glucose, fatigue recovery and regulation of intestinal function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	systolic pressure and diastolic pressure (hospital pressure and home pressure) , peripheral blood flow
Key secondary outcomes	T-Cho, HDL-Cho, LDL-Cho, TG, fasting plasma glucose, HbA1c, hs-CRP, adiponectin, platelet aggregation, defecation frequency, VAS questionnaire

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of the plum extract pill daily for 12 weeks
Interventions/Control_2	Ingestion of the placebo pill 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects whose SBP is between 130mmHg and 160mmHg 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) 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, etc.) which would affect the blood pressure. 9. Heavy smokers, alcohol addicts or subjects with irregular lifestyle 10. Subjects who donate either 400ml whole blood within 12 weeks 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	52

Research contact person
Name of lead principal investigator	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Center of Health Information Science
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 27 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2015 Year 11 Month 16 Day
Date of closure to data entry	2015 Year 12 Month 17 Day
Date trial data considered complete	2015 Year 12 Month 24 Day
Date analysis concluded	2016 Year 04 Month 08 Day

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

Management information
Registered date	2015 Year 06 Month 16 Day
Last modified on	2016 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020770