UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016586
Receipt number R000018813
Scientific Title A clinical study for evaluating the safety of excessive consumption of the honey vinegar beverage
Date of disclosure of the study information 2016/06/30
Last modified on 2015/02/02 09:39:10

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Basic information

Public title

A clinical study for evaluating the safety of excessive consumption of the honey vinegar beverage

Acronym

A clinical study for evaluating the safety of excessive consumption of the honey vinegar beverage

Scientific Title

A clinical study for evaluating the safety of excessive consumption of the honey vinegar beverage

Scientific Title:Acronym

A clinical study for evaluating the safety of excessive consumption of the honey vinegar beverage

Region

Japan


Condition

Condition

hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of excessive consumption of the honey vinegar beverage in the subjects with high normal blood pressure or grade 1 hypertension or normotensive

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Blood chemistry, hematology, urinalysis, body weight, systolic blood pressure, diastolic blood pressure, pulse rate, medical interview

Key secondary outcomes



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


Blocking

NO

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Excessive consumption of the honey vinegar beverage for 4 weeks

Interventions/Control_2

Excessive consumption of the control beverage without honey vinegar for 4 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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Subjects aged from 20 to 65 years old
2)Subjects with high normal blood pressure(systolic BP from 130 to 139/ or diastolic BP from 85 to 89 mm Hg) or grade 1 hypertension (systolic BP from 140 to 159/ or diastolic BP from 90 to 99 mm Hg) or normotensive
3)Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent

Key exclusion criteria

1) Subjects who need an urgent anti-hypertensive treatment
2) Subjects who have a symptom of cerebrovascular diseases
3) Heart failure patients or subjects who have a history of myocardial infarction
4) Subjects who have an atrial fibrillation or a severe arrhythmia
5) Subjects who have a severe renal dysfunction (serum creatinine >=2 mg/dl)
6) Subjects who have severe hepatic, cardiovascular, respiratory disease, endocrine or metabolic disorders
7) Subjects who have a history of the hypersensitivity or an allergy for test foods in this study
8) Subjects who have a secondary hypertension
9) Subjects who regularly take any anti-hypertensive drug or FOSHU for improving hypertension
10) For female: Subjects with pregnant or breast feeding , or those who have a plan to be pregnant during the study period
11) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study
12) Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
13) Subject deemed unsuitable by the investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osami Kajimoto

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Medical Science on Fatigue

Zip code


Address

1-4-3 Asahimachi, Abeno-ku, Osaka

TEL

06-6645-6171

Email

kajimoto@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code


Address

Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka

TEL

06-6871-8888

Homepage URL


Email

sugino@soiken.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

Yamada Bee Company, Inc.

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

ふくだ内科クリニック(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 30 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

Preinitiation

Date of protocol fixation

2014 Year 11 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 20 Day

Last modified on

2015 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018813


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name