UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028384
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email imai@croee.com

Sponsor
Institute CROee.INC
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032478

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.