UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062203 |
|---|---|
| Receipt number | R000071177 |
| Scientific Title | Effects of test food consumption on vascular endothelial function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/10 13:46:16 |
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Basic information
Public title
Effects of test food consumption on vascular endothelial function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of test food consumption on vascular endothelial function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of test food consumption on vascular endothelial function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of test food consumption on vascular endothelial function in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food consumption on vascular endothelial function in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Measured value of flow mediated dilation (FMD) at 12 weeks after the intervention (12w)
Key secondary outcomes
1. Change and percentage change in FMD from screening to 12w
2. Measured values of maximum vessel dilation and resting vessel diameter at 12w, and their change and percentage change from screening
3. Measured values of interleukin-6 and high-sensitivity C-reactive protein at 12w, and their change and percentage change from screening
4. Individuals who experienced adverse events
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Food containing Pycnogenol (R)
Administration: Consume two capsules once per day with water
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
Interventions/Control_2
Duration: 12 weeks
Test product: Starch (Placebo)
Administration: Consume two capsules once per day with water
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 40-64 years
4. Healthy individuals
5. Individuals whose FMD is >= 4% and < 7% at screening
Key exclusion criteria
1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who receive hormonal therapy
5. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims
6. Individuals who consume foods or beverages containing functional ingredients that may influence vascular endothelial function (e.g., procyanidins, lactotripeptides, black soybean polyphenols, or elastin peptides)
7. Individuals who are taking or using medications (including herbal medicines) or supplements
8. Individuals who are allergic to medications or foods related to the test product, especially those who are allergic to pine trees
9. Individuals whose working form is irregular
10. Individuals who engage in intense exercise
11. Individuals who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} every day
12. Individuals who are pregnant, lactating, or planning pregnancy during this study
13. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Horphag Research (Asia) Limited
Institute
Department
Personal name
Funding Source
Organization
Horphag Research (Asia) Limited
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 ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
| 2026 | Year | 07 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical analysis details>
Subgroups will consist of populations from the total study population who meet the following criteria:
Individuals with post-COVID-19 condition in the preliminary survey / Individuals without post-COVID-19 condition in the preliminary survey
Management information
Registered date
| 2026 | Year | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071177
