UMIN-CTR Clinical Trial

Public title

Exploratory test on the effect of test food on blood pressure

Acronym

Exploratory test on the effect of test food on blood pressure

Scientific Title

Exploratory test on the effect of test food on blood pressure

Scientific Title:Acronym

Exploratory test on the effect of test food on blood pressure

Region

Japan

Condition

Healthy volunteer

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate improvement effects of test food on high blood pressure

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Blood pressure after eight weeks ingestion of test food

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of test food consecutively for eight weeks

Interventions/Control_2

Ingestion of placebo for eight 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

Age-lower limit

50

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Healthy male and female 50 to 65 years at the time of informed consent
2)Visit systolic blood pressure is more than 130 mmHg and less than 159 mmHg or diastolic blood pressure is more than 85 mmHg and less than 99 mmHg in the screening test
3)Subjects who are estimated intaking daily salt is more than 8.0 g for men or more than 7.0 g for female in occasional urinalysis of screening tests
4)Subjects who are received sufficient explanation about purpose and content of this exam and have the capacity to consent and voluntarily write participation agreement in this examination voluntarily participate after understanding well

Key exclusion criteria

1)Subjects who are previous or present serious disease such digestive, liver, kidney, circulatory, blood, endocrine disorder.
2)Subjects who are taking medicine or being treated by a doctor
3)Subjects who are intend to undergo treatment or medication by a doctor during the test period.
4)Subjects who plan to take specified healthy food, functionality food, supplement in the test period
5)Subjects who may change meal (the number of times meal, diet, alcohol intake)
6)Subjects who may change lifestyle (night work, long-term travel, relocation)
7)Subjects who smoke present or have smoked within the last one year prior to the current study
8)Subjects who was diagnosed as secondary hypertension
9)Women who are pregnant or may be pregnant
10)Women who are breast-feeding
11)Woman whose last menstruation has not passed more than one year
12)Subjects who donated 200 mL in the past month or more than 400 mL within 3 months (blood donation etc.)
13)Subjects who participated in other clinical trials within the past 3 months or currently participating in other clinical trials or planning to participate in other clinical trials during the examination period.
14)Subjects who may cause allergic to grape plant
15)Subjects who are judged as unsuitable for the study by the doctor

Target sample size

92

Name of lead principal investigator

1st name
Middle name
Last name	Masahiro Fukuda

Organization

Fukuda Clinic

Division name

Director

Zip code

Address

Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka

TEL

06-6398-0203

Email

fukuda@drmog.jp

Name of contact person

1st name
Middle name
Last name	Tomohiro Sugino

Organization

Soiken Inc.

Division name

Representative Director

Zip code

Address

Senri Life Science Center 13F, 1-4-2 Shin-senrihigashimachi, Toyonaka, Osaka

TEL

06-6871-8888

Homepage URL

Email

sugino@soiken.com

Institute

Soiken Inc.

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

19

Day

Date of IRB

Anticipated trial start date

2017

Year

10

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

09

Month

29

Day

Last modified on

2018

Year

04

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033538