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
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
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
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
