UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060890 |
|---|---|
| Receipt number | R000065385 |
| Scientific Title | A post-hoc analytical study on the effects of test food intake on fundus and nail bed blood flow |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/10 11:05:05 |
* 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
A post-hoc analytical study on the effects of test food intake on fundus and nail bed blood flow
Acronym
A post-hoc analytical study on the effects of test food intake on fundus and nail bed blood flow
Scientific Title
A post-hoc analytical study on the effects of test food intake on fundus and nail bed blood flow
Scientific Title:Acronym
A post-hoc analytical study on the effects of test food intake on fundus and nail bed blood flow
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 perform various statistical analyses, such as correlation analysis and stratified analysis, of the ''Study title: Study on the effects of test food intake on fundus and nail bed blood flow (UMINID: UMIN000050401)'' conducted from February to April 2023, using pseudonymized information for more detailed analysis, characterization of Flammer normal subjects, and clarification of the mechanism of action. The purpose of this study is to perform various statistical analyses, such as correlation analysis and stratification analysis, from the viewpoint of characterizing Flammer's healthy subjects and clarifying the mechanism of action.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Postmortem analysis items
[1] Stratified analysis
[2] Correlation analysis
[3] Other additional analysis
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Healthy Japanese males and females aged 30-59 years.
[2] Individuals who are healthy and have no chronic physical disease.
[3] Individuals whose constitution corresponds to the Flammer syndrome.
[4] Individuals whose written informed consent has been obtained after explanation of this study.
[5] Individuals who can have an examination on a designated check day
[6] Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals using medical products.
[2] Individuals who have or have a medical history that could affect the outcome of the study.
[3] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[4] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[5] Individuals who are a patient or have a history of or endocrine disease.
[6] Individuals who have or have a history of eye diseases that may affect the results of the study.
[7] Individuals whose spherical equivalent power is outside the range of -6.0 to +1.0 diopters.
[8] Individuals whose intraocular pressure is over 21 mmHg.
[9] Individuals who have a history of ophthalmic laser surgery or incision surgery.
[10] Individuals whose BMI is over 30 kg/m2.
[11] Individuals with drug and food allergies.
[12] Individuals who use a drug to treat a disease in the past 1 month.
[13] Individuals who currently or within the past 3 months have a habit of taking foods for specified health uses, foods with function claims, health foods, and supplements which affect affect blood pressure and blood flow, or plan to take them during the test period.
[14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day).
[15] Individuals with possible changes of life style during the test period.
[16] Individuals who are likely to develop seasonal or perennial allergic symptoms during the study period and who may use pharmaceuticals (eye drops and nasal drops are acceptable).
[17] Individuals who are a smoker.
[18] Individuals who engage in a night work.
[19] Individuals who are or are possibly pregnant, or are lactating.
[20] Individuals who participated in other clinical studies in the past 3 months.
[21] Individuals who are or whose family is engaged in healthy or functional foods.
[22] Individuals judged inappropriate for the study by the principal.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Yamada |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo
TEL
03-6832-6013
aoyagi@rohto.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
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University
TES Holdings Co., Ltd.
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 | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ex-post analysis study
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065385
