UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.
Title of the study (Brief title)	Effects of Daily Ingestion Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove clinical benefits associated with daily shiikuwasha juice ingestion for 8 weeks on blood pressure and also to investigate the potential health benefits of shiikuwasha juice including improvement in lipid and glucose metabolism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Systolic and diastolic blood pressure at 4 and 8 weeks after ingestion of test meals.
Key secondary outcomes	TC, LDL-C, HDL-C, TG, fasting plasma glucose, HbA1c, body weight, BMI, body fat percentage.

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	Daily ingestion of 95 ml of shiikuwasha juice for 8 weeks.
Interventions/Control_2	Daily ingestion of 95 ml of placebo beverage for 8 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 SBP in a clinic is >=130 mmHg and <160 mmHg. 2. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria	1. Subjects who are under physician's advice, treatment and/or medication for hypertension. 2. Subjects who have (or suspected) secondary hypertension such as chronic glomerulonephritis, pyelonephritis, primary aldosteronism, phaeochromocytoma, Cushing's syndrome, hyperthyroidism, etc. 3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 4. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 6. Subjects with severe anemia. 7. Pre- or post-menopausal women complaining obvious physical changes. 8. Subjects who are at risk of having allergic reactions to drugs or foods (especially citrus fruits). 9. 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 potentially affect the blood pressure. 10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 11. 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 the current study. 12. Pregnant or lactating women or women expect to be pregnant during this study. 13. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 14. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
Target sample size	40

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	Health Information Science Center
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	Clock Work Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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 10 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 29 Day
Anticipated trial start date	2016 Year 10 Month 28 Day
Last follow-up date	2017 Year 01 Month 23 Day
Date of closure to data entry	2017 Year 02 Month 06 Day
Date trial data considered complete	2017 Year 02 Month 13 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 10 Month 26 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=R000028280