UMIN-CTR Clinical Trial

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

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