UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060452 |
|---|---|
| Receipt number | R000068922 |
| Scientific Title | Study on the Effects of Test Food Intake on Improving Cardiovascular Function - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial - |
| Date of disclosure of the study information | 2026/01/25 |
| Last modified on | 2026/01/07 12:45:17 |
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Basic information
Public title
Study on the Effects of Test Food Intake on Improving Cardiovascular Function
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Acronym
Study on the Effects of Test Food Intake on Improving Cardiovascular Function
Scientific Title
Study on the Effects of Test Food Intake on Improving Cardiovascular Function
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Scientific Title:Acronym
Study on the Effects of Test Food Intake on Improving Cardiovascular Function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects on cardiovascular function-related indicators and the safety of continuous consumption of the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular-related indicators
Key secondary outcomes
*Secondary Endpoints
1) QOL Questionnaire
2) Brief Dietary History Questionnaire (BDHQ)
*Exploratory Evaluation Items
1) Quantification of Active Ingredients in Blood
*Safety Evaluation Items
1) Weight/Body Fat Percentage/BMI
2) Hematological Tests
3) Blood Biochemical Tests
4) Urinalysis
5) Physician Interview/Adverse Event/Side Effect Investigation
6) Subject Diary
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
Oral intake of the test food (1 capsule in a day; 12 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 capsule in a day; 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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 40 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals with LDL cholesterol in the borderline range (120 mg/dL to 139 mg/dL) or mildly elevated range (140 mg/dL to 159 mg/dL).
4) Individuals with slightly elevated blood pressure.
5) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
6) Individuals who can attend the designated examination date and undergo the examination.
7) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any disease and undergoing drug treatment.
2) with a current medical history of mental disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or a past or current history of serious diseases.
3) with a history of serious past or current medical conditions involving the liver, kidneys, heart, lungs, blood, digestive organs, etc.
4) who have habitually taken or applied medications for disease treatment within the past month (excluding occasional use for conditions such as headaches or menstrual pain).
5) whose BMI is over 30 kg/m2.
6) who may experience allergic reactions to components contained in the test food, as well as individuals who may experience severe allergic reactions to other foods or pharmaceuticals.
7) with dietary habits that may affect test results.
8) who currently have, or have had within the past three months, a habit of continuously consuming foods for specified health uses, foods with functional claims, or health foods.
9) whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women.
10) who have a smoking habit.
11) working rotating shifts or night shifts.
12) whose lifestyle may undergo significant changes during the examination period, such as extended business trips or travel.
13) who have donated blood exceeding 200 mL within the past month or 400 mL within the past 3 months.
14) who are pregnant, breastfeeding, or may become pregnant during the examination period
15) currently participating in other human clinical trials, or individuals who have participated in other human clinical trials within the past 3 months.
16) Other individuals deemed ineligible for this trial by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Abe |
Organization
Taiyo Kagaku Co., Ltd
Division name
NUTRITION DIVISION
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichi, Mie, JAPAN
TEL
059-347-5411
aabe@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2026 | Year | 01 | Month | 25 | 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 | 12 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 22 | 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 | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068922
