UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020470
Receipt number R000023492
Scientific Title Effects of a Drink Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure
Date of disclosure of the study information 2016/01/07
Last modified on 2016/05/10 11:43:29

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Basic information

Public title

Effects of a Drink Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure

Acronym

Effects of a Drink Containing Fermented Soba Extract on the Decrease of Blood Pressure

Scientific Title

Effects of a Drink Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure

Scientific Title:Acronym

Effects of a Drink Containing Fermented Soba Extract on the Decrease of Blood Pressure

Region

Japan


Condition

Condition

N/A(healthy adults with 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 drink 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

[1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12)

Key secondary outcomes

[1]Adrenal medulla test (Week 0, Week 12)
[2]Hematologic test
[3]Blood biochemical test
[4]Urine analysis
[5]Hight(Screening)
[6]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8, Week 12)
[7]Doctor's questions (Screening, Week 0, Week 4, Week 8, Week 12)
[8]Subject's diary(From the first day of ingestion of a test material to the last day of the test)


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

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Oral ingestion of the test products containing fermented soba extract (100g per a day; 12 weeks)

Interventions/Control_2

Oral ingestion of the placebo not containing fermented soba extract (100g per a day; 12 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

30 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 30-70 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals who is 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 using medical products
[2]Individuals whose condition is secondary hypertension (ex. renal artery stenosis, renal hypertension, renovascular hypertension, pheochromocytoma, disease of adrenal cortex)
[3]Individuals who have a history of bronchial disease (ex. asthma, tuberculosis, pleurisy)
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[5]Individuals who are sensitive to a food containing soba and test product or other foods, and medical products
[6]Individuals who have a history of hepatitis
[7]Individuals with serious anemia
[8]Individuals whose BMI is over 30
[9]Individuals who have a habit of smoking
[10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[11]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer)
[12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period
[13]Individuals who participated in other clinical studies in the past three months
[14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[15]Individuals who are or are posslibly, or are lactating
[16]Individuals judged inappropriate for the study by the principal

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norimasa Sato

Organization

Medical Corporation Oryokukai Umeda Oak Clinic

Division name

Internal Medicine

Zip code


Address

Kozuki Capital West Bldg. 8F, 2-6-6 Sonezaki Kita-ku Osaka-shi Osaka, 530-0057, JAPAN

TEL

06-6130-8735

Email

info@tes-h.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyasu Tamura

Organization

TES Holdings Co., Ltd.

Division name

Department of Clinical Trial

Zip code


Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL


Email

info@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



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 01 Month 07 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

2015 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 04 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 01 Month 07 Day

Last modified on

2016 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023492


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name