UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024575
Receipt number R000028280
Scientific Title A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.
Date of disclosure of the study information 2016/10/27
Last modified on 2017/06/15 14:22:36

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Basic information

Public title

A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.

Acronym

Effects of Daily Ingestion Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.

Scientific Title

A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.

Scientific Title:Acronym

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

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

Health Information Science Center

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 or person

Institute

Hokkaido Information University

Institute

Department

Personal name



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)



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 10 Month 27 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 09 Month 29 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028280


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name