UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057433 |
|---|---|
| Receipt number | R000065468 |
| Scientific Title | Evaluation of the effects of test food consumption on capillaries |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2026/03/13 16:34:26 |
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Basic information
Public title
Evaluation of the effects of test food consumption on capillaries
Acronym
Evaluation of the effects of test food consumption on capillaries
Scientific Title
Evaluation of the effects of test food consumption on capillaries
Scientific Title:Acronym
Evaluation of the effects of test food consumption on capillaries
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of continuous consumption of the test foods on vascular function, antioxidant and quality of life related indices.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capillary index
(Week 0, Week 6, Week 12)
Key secondary outcomes
* Secondary endpoint
1) Autonomic Balance, Accelerated Pulse Wave (1)
2) LOX-index (1)
3) Antioxidant-related index test (1)
4) POMS2 Japanese (abridged version) (1)
5) Lifestyle and Experience Questionnaire (1)
* Safety endpoints
1) physical examination ( Blood pressure/beat, weight/body fat percentage/BMI ) (1)
2) Clinical laboratory tests (hematology, blood biochemistry, general urinalysis) (1)
3) Doctor's questions (1)
4) Side effects/ Adverse events (2)
5) Subject's diary ( Adverse event investigation ) (3)
(1): Week 0, Week 6, Week 12
(2): Week 6, Week 12
(3): From the first day of ingestion of a test material to the last day of the test.
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 (2 bottles a day ; 12 weeks)
Interventions/Control_2
Oral intake of the placebo food (2 bottles 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 59 years of age at the time of obtaining consent to participate in the study.
2) Individuals who feel stressed or fatigued in their daily lives.
3) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
4) Individuals who can come to the designated venue for this study and be inspected.
Key exclusion criteria
Individuals
1) with chronic diseases and individuals undergoing treatment for any disease.
2) Individuals with a history or current history of chronic fatigue syndrome, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness.
3) with a history of serious or current illness in the liver, kidney, heart, lungs, blood, or gastrointestinal tract.
4) with serious anemia.
5) who used a drug to treat a disease in the past 1 month.
6) whose BMI is over 30 kg/m2.
7) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
8) who are currently, or have been within the past 3 months, habitual consumers of food for specified health uses, functional foods, health foods, supplements, etc., or who plan to consume such foods during the study period.
9) with a habit of consuming foods that may affect the study.
10) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent.
11) who are at risk of developing hay fever or other seasonal allergic symptoms and may use pharmaceutical medication or nasal drops.
12) who are a smoker.
13) with irregular lifestyles, such as shift work, night work, etc.
14) with possible changes of life style during the test period.
15) with inflammation or wounds on the fingers.
16) who have had more than 200 mL of blood drawn (e.g., blood donation) within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study.
17) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
18) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period.
19) judged inappropriate for the study by the principal.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
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
Ezaki Glico 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
| 2025 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 16 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065468
