UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056970 |
|---|---|
| Receipt number | R000065027 |
| Scientific Title | A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management. (SBF-2024-06) |
| Date of disclosure of the study information | 2025/02/09 |
| Last modified on | 2025/02/05 15:17:37 |
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Basic information
Public title
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management. (SBF-2024-06)
Acronym
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management.
Scientific Title
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management. (SBF-2024-06)
Scientific Title:Acronym
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure; Systolic blood pressure and Diastolic blood pressure
Key secondary outcomes
Lifestyle management
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
Daily intake of test food with lifestyle management for 12 weeks
Interventions/Control_2
Daily intake of control food with lifestyle management 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females who are >- 20 years old at the time of IC acquisition and <65 years old at the end of the study.
(2) Subject, 130 mmHg <- SBP <- 159 mmHg, or 85 mmHg <- DBP <- 99 mmHg.
(3) Those who have submitted written informed consent after fully understanding the purpose and content of this study.
Key exclusion criteria
(1) Those who systolic blood pressure is less than 90 mmHg.
(2) Those who wish to become pregnant, are / might be pregnant or lactating during the study.
(3) Those who are participating in other study or planning to participate or participated within the past 4 weeks.
(4) Those who are;
a) With disease on brain, heart, liver, kidney or other organs complications.
b) Having a history of cardiovascular disease.
c) Having a history of antihypertensive medication.
d) With diabetes.
e) With test food allergy.
f) Having a history of serious illnesses such as cancer or tuberculosis.
(5) Those who are undergoing some medical treatment at the time of the eligibility assessment test.
(6) Those who regularly use medicines, quasi-drugs, foods for specified health uses, foods with functional claims, health foods, etc. that may affect the evaluation.
(7) Those who heavy use of alcohol or smoke.
(8) Those who have an unsteady lifestyle because of a working shift or a night shift.
(9) Those who have regular hard exercise.
(10) Those who are unable to improve their lifestyle or those who are making sufficient efforts.
(11) Others who are judged inappropriate for participant by the investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Maekawa |
Organization
Suntory Beverage & Food Limited
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1804-0276
Toshihiro_Maekawa@suntory.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Kidokoro |
Organization
Suntory Beverage & Food Limited
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-4524
Homepage URL
Ayako_Kidokoro@suntory.co.jp
Sponsor or person
Institute
Suntory Beverage & Food Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Fukuzumi-2 jo, Toyohira-ku, Sapporo-shi, Hokkaido.
Tel
011-836-3531
shibata@jkkai.or.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
福原医院（北海道） / Fukuhara Clinic (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065027
