UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study
Title of the study (Brief title)	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	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

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（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 05 Day
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

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Publication of results	Unpublished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