UMIN-CTR Clinical Trial

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
Institute	CPCC Company Limited
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040138