UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062088 |
|---|---|
| Receipt number | R000071038 |
| Scientific Title | Evaluation of the Effects of Long-Term Consumption of the Test Food on Blood Pressure and Lipid Metabolism : placebo-controlled, double-blind, randomized parallel comparative study |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/06/29 11:26:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Effects of Long-Term Consumption of the Test Food on Blood Pressure and Lipid Metabolism
Acronym
Evaluation of the Effects of Long-Term Consumption of the Test Food on Blood Pressure and Lipid Metabolism
Scientific Title
Evaluation of the Effects of Long-Term Consumption of the Test Food on Blood Pressure and Lipid Metabolism : placebo-controlled, double-blind, randomized parallel comparative study
Scientific Title:Acronym
Evaluation of the Effects of Long-Term Consumption of the Test Food on Blood Pressure and Lipid Metabolism : placebo-controlled, double-blind, randomized parallel comparative study
Region
| Japan |
Condition
Condition
Adults with elevated LDL cholesterol levels and slightly high blood pressure.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of long-term consumption of the test food on blood pressure and lipid metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure
Diastolic blood pressure
LDL cholesterol
Key secondary outcomes
Triglycerides
HDL cholesterol
Total cholesterol
VLDL cholesterol
IDL cholesterol
GSH (glutathione)
ApoA
ApoB
Homocysteine
Blood glucose
Insulin
HOMA-IR
HbA1c
High-sensitivity CRP
SOD activity
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 the test food for 12 weeks
Interventions/Control_2
Intake the placebo food 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Male and female subjects aged 35 to 59 years.
(2) Subjects with a systolic blood pressure of 120 mmHg or higher, or a diastolic blood pressure of 80 mmHg or higher.
(3) Subjects with an LDL cholesterol level of 120 mg/dL or higher.
(4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
Key exclusion criteria
(1) Subjects with a history of serious diseases such as mental disorders, diabetes, liver diseases, renal diseases, gastrointestinal diseases, cardiac diseases, respiratory diseases, peripheral vascular diseases, or other severe diseases.
(2) Subjects who have undergone gastrointestinal surgery.
(3) Subjects with abnormal liver or renal function test values.
(4) Subjects with diseases currently under treatment.
(5) Subjects with allergies to food or drugs.
(6) Subjects with symptoms of anemia.
(7) Female subjects who wish to become pregnant during the study, or who are pregnant (including those who may be pregnant) or lactating.
(8) Subjects who engage in intense sports or who are on a diet.
(9) Subjects with extremely irregular eating habits.
(10) Subjects who cannot discontinue the intake of health foods (including foods for specified health use and foods with functional claims) or quasi-drugs during the study period.
(11) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs).
(12) Subjects who consume more than 40 g of pure alcohol per day on average.
(13) Subjects who smoke 21 or more cigarettes per day on average.
(14) Subjects who are participating in or will participate in other clinical studies at the start of this study.
(15) Subjects who are judged by the principal investigator or subinvestigator to be inappropriate for the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6809-5220
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
UMEKEN 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6809-5220
mterashima@miura-cl.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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 06 | 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
| 2026 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 11 | 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
| 2026 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071038
