UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure
Acronym	Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure
Scientific Title	Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure
Scientific Title:Acronym	Effects of a Granule Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure
Region	Japan

Condition
Condition	Normal high blood pressure or Grade 1 hypertension
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine effect of a granule containing fermented soba extract (neo-FBS) on the decrease of blood pressure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12)
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test products containing fermented soba extract (2g per a day; 8 weeks)
Interventions/Control_2	Oral ingestion of the test products containing fermented soba extract (2g per a day; 8 weeks)
Interventions/Control_3	Oral ingestion of the placebo not containing fermented soba extract (2g per a day; 8 weeks)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females aged 30-70 years 2) Individuals who are healthy and are not receiving treatment of disease 3) Individuals who are high normal blood pressure (SBP: 130-140mmHg and/or DBP: 85-90mmHg) and Grade 1 hypertension (SBP: 140-160mmHg and/or DBP: 90-100mmHg) 4) Individuals whose written informed consent has been obtained 5) Individuals judged appropriate for the study by the principal
Key exclusion criteria	1) Individuals who are sensitive to a food containing soba and test product or other foods, and medical products 2) Individuals who are receiving treatment of serious hepatopathy, kidney damage, heart disease and hematological disease 3) Individuals who have a habit of smoking 4) Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period 5) Individuals who participated in other clinical studies in the past three months 6) Individuals who are or are possibly pregnant, or are lactating
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toru Sahashi
Organization	SBS Shizuoka Health Promotion Center
Division name	Deputy Director
Zip code
Address	3-1-1, Toro Shizuoka Suruga-ku, Shizuoka
TEL	054-282-1109
Email	dokku@sbs-smc.or.jp

Public contact
Name of contact person	1st name Middle name Last name Masanori Inoue
Organization	Laboratory of Cell Applied Technologies, Co
Division name	Director
Zip code
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki 216-8512 Japan
TEL	044-979-1622
Homepage URL
Email	info@l-cat.co.jp

Sponsor
Institute	Laboratory of Cell Applied Technologies, Co
Institute
Department

Funding Source
Organization	Daiwa Pharmaceutical 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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 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	2016 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 22 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	2016 Year 09 Month 30 Day
Last modified on	2017 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027816

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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