UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056593 |
|---|---|
| Receipt number | R000064675 |
| Scientific Title | Effects of consumption of the test food on the vascular endothelial function in volunteer: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/12/27 |
| Last modified on | 2026/01/27 11:06:52 |
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Basic information
Public title
Effects of consumption of the test food on the vascular endothelial function in volunteer: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the test food on the vascular endothelial function in volunteer: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the test food on the vascular endothelial function in volunteer: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on the vascular endothelial function in volunteer
Region
| Japan |
Condition
Condition
Volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the vascular endothelial function in volunteer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of flow-mediated dilatation (FMD) at 8 weeks after intervention (8w)
Key secondary outcomes
1. The measured value of FMD at 4 weeks after intervention (4w)
2. The amount and percentage of change of FMD from screening (before consumption; Scr) to 4w and 8w
3. The measured values of maximum expansion width of the blood vessel, the resting vessel diameter, brachial ankle pulse wave velocity (baPWV), systolic blood pressure, diastolic blood pressure, interleukin-11 (IL-11), E-selectin and high sensitivity C-reactive protein (CRP) at 4w and 8w, and the amount and percentage of changes of them from Scr
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
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Eight weeks
Test food: Active food
Interventions/Control_2
Duration: Eight weeks
Test food: Placebo food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals whose FMD is 4% or more and less than 7% at Scr
6. Individuals whose baPWV is less than 1.8 m/s at Scr
Key exclusion criteria
Individuals who/whose
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. 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, hemorrhagic disease, hypotension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. usually take foods or beverages that may affect the vascular endothelial function (such as procyanidins, lactotripeptide, black soybean polyphenols, elastin peptides)
6. are taking or using medications (including herbal medicines) or supplements
7. are allergic to medicines and foods related to the test product, particularly who show allergic reactions to citrus fruit
8. working form is irregular
9. engage in intense exercise
10. usually 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)}
11. are pregnant, lactating, or planning to become pregnant during this study
12. may undergo surgery during within the last two weeks before the agreement to participate in this study or within two weeks after the end of consumption
13. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
14. are judged as ineligible to participate in this study by the physician
Target sample size
40
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
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 27 | 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
44
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
| 2024 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064675
