UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052732 |
|---|---|
| Receipt number | R000060117 |
| Scientific Title | A study on the effect of continuous intake of test food on blood pressure and vascular function - a randomized double-blind placebo-controlled study - |
| Date of disclosure of the study information | 2023/11/16 |
| Last modified on | 2023/11/30 09:44:52 |
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Basic information
Public title
A study on the effect of continuous intake of test food on blood pressure and vascular function - a randomized double-blind placebo-controlled study -
Acronym
A study on the effect of continuous intake of test food on blood pressure and vascular function
Scientific Title
A study on the effect of continuous intake of test food on blood pressure and vascular function - a randomized double-blind placebo-controlled study -
Scientific Title:Acronym
A study on the effect of continuous intake of test food on blood pressure and vascular function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effect of test food intake for 12 weeks on blood pressure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Key secondary outcomes
arteriosclerosis related indicators
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
Intake of test food A with water or lukewarm water, 1 tablet at a time, twice a day for 12 weeks, before breakfast and dinner.
Interventions/Control_2
Intake of test food B with water or lukewarm water, 1 tablet at a time, twice a day for 12 weeks, before breakfast and dinner.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 40 or more, and under 65
2. Japanese male or female
3. Systolic blood pressure at a start of the trial, between 130 and 139 mmHg, and diastolic blood pressure below or equal to 89 mmHg
4. Subjects who can use smartphones or PC to record a digital diary
5. Subjects who received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent
Key exclusion criteria
1. Patients with or suspected of having secondary hypertension
2. Receiving continuous pharmaceutical treatment with drugs, including use as needed
3. Receiving any dietary or exercise treatment under medical doctors
4. Current or a history of serious disease
5. Current or a history of mental disease, sleep disorder, hypertension, diabetes, dyslipidemia, or serious illness
6. 4.Current or a history of serious disorders of the liver, kidneys, heart, lungs, blood
7. Having history of surgery on the gastrointestinal tract, except appendicitis
8. Have a current or past history of drug or food allergy symptoms
9. Alcohol drinkers, over 40 g/day of alcohol
10. Heavy smoker, over 20 cigarettes/day
11. Unstable rhythm of daily life (ex. engaged in night work or split shift)
12. planning to make significant changes to lifestyle habits (diet, sleep, exercise habits, etc.) during the study period
13. Currently pregnant or breastfeeding, or wishing to become pregnant during the study period
14. Have participated another clinical study within 1 month before IC, or will participate in it during the study period or within 1 month after the end of the study
15. Unsuitable for the study judged by the investigators
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Miyamoto |
Organization
Marukyou Bio Foods Co., Ltd.
Division name
Headquarters
Zip code
097-0022
Address
4-18-18 Chuo, Wakkanai, Hokkaido
TEL
0162-23-4055
miyamoto@mbf-net.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza bldg. 3F, 6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
sales-contact@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Marukyou Bio Foods 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2023 | Year | 11 | Month | 16 | 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
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060117
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