UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062279 |
|---|---|
| Receipt number | R000071274 |
| Scientific Title | Evaluation of the effects of vegetable juice consumption on skin, visual, and vascular functions in young adults |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/07/20 15:36:10 |
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Basic information
Public title
Evaluation of the effects of vegetable juice consumption on skin, visual, and vascular functions in young adults
Acronym
Evaluation of the effects of vegetable juice consumption on skin, visual, and vascular functions in young adults
Scientific Title
Evaluation of the effects of vegetable juice consumption on skin, visual, and vascular functions in young adults
Scientific Title:Acronym
Evaluation of the effects of vegetable juice consumption on skin, visual, and vascular functions in young adults
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of vegetable juice consumption on skin, visual, and vascular functions in young adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin carotenoid score
Key secondary outcomes
Skin sebum level and stratum corneum hydration
Macular pigment optical density (MPOD) score
Salivary secretory IgA (sIgA) concentration
Nailfold capillaroscopy findings
Blood pressure and vascular indices (API, AVI, vascular age)
Urinary sodium-to-potassium ratio
Urinary biopyrrin concentration
Body composition (height, weight, body fat percentage)
Subjective assessment of eye and skin condition (Visual Analog Scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants intake vegetable juice (160 g) daily for four weeks.
Interventions/Control_2
Participants intake water (160 g) daily for four 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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy male and female between 18 and 35 years old
2)Voluntarily agrees to participate after understanding the purpose and content of the research, and provides written consent
Key exclusion criteria
1)Individuals who regularly consume vegetable juice
2)Individuals who are currently taking, or plan to take during the study period, any medications, quasi-drugs, supplements, health-functional foods (nutrient function foods, Foods for Specified Health Uses, Foods with Function Claims), or carotenoid-fortified foods that may influence the study outcomes
3)Individuals with a potential allergy to the test beverage or who have an aversion to its taste
4)Individuals who are expected to have days during the study period when they cannot consume the test beverage
5)Current smokers
6)Individuals for whom fingertip-based measurements are difficult
7)Individuals who have difficulty completing the questionnaires
8)Individuals who are pregnant or breastfeeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
yoshimi.kishimoto@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
Homepage URL
yoshimi.kishimoto@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
ITOEN 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
Setsunan University Ethical Review Committee for Medical and Health Research Involving Human Subjects
Address
17-8, Ikedanaka-machi, Neyagawa, Osaka
Tel
0728001160
setsunan.kenkyu.shakai@josho.ac.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 | 07 | Month | 20 | 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 | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | 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 | 07 | Month | 20 | Day |
Last modified on
| 2026 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071274
