UMIN-CTR Clinical Trial

Public title

Influence by the food intake for adult men and women having high blood pressure

Acronym

Influence by the food intake for adult men and women having high blood pressure

Scientific Title

Influence by the food intake for adult men and women having high blood pressure

Scientific Title:Acronym

Influence by the food intake for adult men and women having high blood pressure

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of blood pressure level by research food during continuous intake for 12 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Clinic blood pressure

Key secondary outcomes

Home blood pressure (morning, night).
Flow-mediated dilation.
Profile of mood states 2nd edition/
Visual analogue scale for Fatigue.
Visual analogue scale for sleep and symptom of the everyday life.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of the test product for 12 weeks

Interventions/Control_2

Intake of the placebo for 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 64 years of age
(2) Those who falling under the following criteria in preliminary examination I
(130 mmHg<=SBP<160 mmHg or 85 mmHg<=DBP<100 mmHg)
(3) Blood pressure gives priority to a high person and chooses it among people corresponding to the following criteria in preliminary examination II
(120 mmHg<=SBP<140 mmHg or 80 mmHg<=DBP<90 mmHg)
(4) Subjects who obtained the consent about participation in the study

Key exclusion criteria

(1) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(2) Subjects with more than of grade I high blood pressure in preliminary examination II
(140<=SBP or/and 90<=DBP)
(3) Subjects who routinely take medicine or health foods that may affect the results
(4) Subjects taking medicine which may affect the results
(5) Subjects having a disease requiring treatment, under mediation or a history of serious diseases for which medication was required
(6) Subjects who regularly consume large amount of alcohol
(7) Subjects who smoke excessively
(8) Subjects having possibilities for emerging allergy related to the study
(9) Subjects judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality in the past
(10) Subjects who are judged as unsuitable for the study based on the results of physical measurement and clinical examination
(11) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(12) Subjects who intend to become pregnant or lactating
(13) Subjects who cannot follow restrictions
(14) Subjects who judged as unsuitable for the study by the investigator for other reasons

Target sample size

80

Name of lead principal investigator

1st name	Teruki
Middle name
Last name	Aizawa

Organization

Yaizu Suisankagaku Industry Co., Ltd.

Division name

Research & Development Dept.

Zip code

425-8570

Address

5-8-13 Kogawashinmachi, Yaizu-City, Shizuoka Pref.

TEL

054-621-0112

Email

t-aizawa@yskf.co.jp

Name of contact person

1st name	Chiharu
Middle name
Last name	Goto

Organization

EP Mediate Co., Ltd.

Division name

Foods Department, Trial Planning Section

Zip code

162-0821

Address

1-8 Tsukudocho, Shinjuku-ku, Tokyo Kagurazaka AK Building 7F

TEL

090-1536-4583

Homepage URL

Email

goto.chiharu069@eps.co.jp

Institute

EP Mediate Co., Ltd.

Institute

Department

Personal name

Organization

Yaizu Suisankagaku Industry Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

nakagawa.akiko297@eps.co.jp

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

2022

Year

09

Month

02

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

No longer recruiting

Date of protocol fixation

2022

Year

07

Month

28

Day

Date of IRB

2022

Year

07

Month

28

Day

Anticipated trial start date

2022

Year

09

Month

03

Day

Last follow-up date

2023

Year

02

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

09

Month

02

Day

Last modified on

2023

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055636