UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035223
Receipt number R000040138
Scientific Title A examination test of effects on blood pressure by consumption of the test food
Date of disclosure of the study information 2020/04/20
Last modified on 2020/10/09 11:42:21

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Basic information

Public title

A examination test of effects on blood pressure by consumption of the test food

Acronym

A examination test of effects on blood pressure by consumption of the test food

Scientific Title

A examination test of effects on blood pressure by consumption of the test food

Scientific Title:Acronym

A examination test of effects on blood pressure by consumption of the test food

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify effects on blood pressure by consumption of the test foods.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

*Blood pressure

Key secondary outcomes

*Changing rate of blood pressure
*Emission volume of sodium ion in 24-hours urine
*Incidence of adverse events and of side effects


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

Prevention

Type of intervention

Food

Interventions/Control_1

Test participants intake one package of test food dissolved in 180 mL water 3 times a day 15 min before each meal for 12 weeks. Test participants visit clinic to receive tests on before start of test food consumption and 4 weeks, 8 weeks and 12 weeks after start of test food consumption.

Interventions/Control_2

Test participants intake one package of control food dissolved in 180 mL water 3 times a day 15 min before each meal for 12 weeks. Test participants visit clinic to receive tests on before start of control food consumption and 4 weeks, 8 weeks and 12 weeks after start of control food consumption.

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

20 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Males and females aged 20 to 59 years old when informed consent.
(2)Subjects whose body mass index (BMI)is included between 18.5kg/m2 to less than 30.0kg/m2.
(3)Subjects who show their systolic blood pressure between 130mmHg to 139mmHg before start of test food consumption or subjects who show their diastolic blood pressure between 85mmHg to 89mmHg before start of test food consumption.
(4)Subjects who intake comparably large amount of salt from their daily meals.
*Estimated amount of their intake of salt are over 8.0g/day in male and over 7.0g/day in female.
(5)Subjects giving written informed consent

Key exclusion criteria

(1) Subjects who have a disease or who are given continuous treatment by taking medicines.
(2) Subjects who plan to start treatment by taking medicines such as pollen allergy during the test term.
(3) Subjects who constantly use oral medicines, functional foods, health foods and/or supplements having a possibility of affecting blood pressure.
(4) Smokers
(5) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(6) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
(7) Subjects who excessive alcohol intake.
(8) Subjects who have extremely irregular dining habits, and subjects who have irregular life rhythm such as shift work or midnight work.
(9) Subjects who have previous medical history of allergy for drugs, foods (especially for melon and apple), ribgrass pollen and/or lawn pollen.
(10) Subjects who are weak to acidic taste
(11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(12) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(13) Males who donated over 400mL blood within the last three months to the current study.
(14) Females who donated over 400mL blood within the last four months to the current study.
(15) Males who will be collected over 1200mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
(16) Females who will be collected over 800mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
(17) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Suguru
Middle name
Last name Fujiwara

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

165-0027

Address

4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name Mitsuhiro
Middle name
Last name Fujimoto

Organization

CPCC Company Limited

Division name

Planning & Sales Department

Zip code

165-0027

Address

4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.j


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

NISSIN FOODS HOLDINGS 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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwauchikanna Bilding , 3-3-5 Uchikanda, chiyoda-ku, Tokyo, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp


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

2020 Year 04 Month 20 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

72

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

2018 Year 12 Month 10 Day

Date of IRB

2018 Year 12 Month 06 Day

Anticipated trial start date

2018 Year 12 Month 13 Day

Last follow-up date

2019 Year 12 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 11 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name