UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028384 |
|---|---|
| Receipt number | R000032478 |
| Scientific Title | A study to investigate effects of study food substance on lowering blood pressure: a verification study |
| Date of disclosure of the study information | 2017/07/26 |
| Last modified on | 2018/07/19 14:21:27 |
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Basic information
Public title
A study to investigate effects of study food substance on lowering blood pressure: a verification study
Acronym
A verification study to assess the effects of study food substance ingestion on lowering blood pressure.
Scientific Title
A study to investigate effects of study food substance on lowering blood pressure: a verification study
Scientific Title:Acronym
A verification study to assess the effects of study food substance ingestion on lowering blood pressure.
Region
| Japan |
Condition
Condition
High-normal blood pressure and Grade 1 hypertension patients
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of healthy drink single ingestion on reducing blood pressure in high-normal blood pressure and grade 1 hypertension adult.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Systolic blood pressure and diastolic blood pressure
Key secondary outcomes
Subjective evaluation 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
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of study food substance (including involved raw materials 45g).
Interventions/Control_2
Single ingestion of study food substance (including involved raw materials 90g).
Interventions/Control_3
Single ingestion of control food substance.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects with high normal blood pressure (systolic BP from 130 to 139, or diastolic BP from 85 to 89 mm Hg) and grade 1 hypertension (systolic BP from 140 to 159, or diastolic BP from 90 to 99 mm Hg)
2) BMI more than 18.5 kg/m2 but less than 30 kg/m2
2) Subjects who give consent in writing
Key exclusion criteria
1) Subjects who have serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, metabolic system,
(2) Subjects who are under medication on a steady basis or history of medication for serious disorders
(3) Subjects who are under treatment at healthcare facility for digestive system that effects on this study or have history of operation on digestive system (except appendectomy)
4) Subjects who have history of intolerance to study food substance
5) Subject with allergy to fruit
6) Subjects who are in pregnancy, lactation, or who are willing to become pregnant
7) Subjects who participated in other drug or food study within 1 month
8) Heavy smoker (20 or more/day) and heavy drinker (converted to alcohol 30g or more/day), or subjects with irregular lifestyle
(9) Subjects who are ineligible due to physician's judgment based on background of subject, physical finding, interview
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko Ide |
Organization
Medical Corporation Chisei-kai Tokyo Center Clinic
Division name
Medical Corporation Chisei-kai Tokyo Center Clinic
Zip code
Address
Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo
TEL
03-3276-6935
miyake@tc-clinic.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
CROee.INC
Division name
Evidence Division
Zip code
Address
2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
imai@croee.com
Sponsor or person
Institute
CROee.INC
Institute
Department
Personal name
Funding Source
Organization
euglena Co., Ltd.
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
東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 26 | 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
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 18 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032478
