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
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
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
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
