UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054266 |
|---|---|
| Receipt number | R000061968 |
| Scientific Title | Investigation of approaches to increase vegetable and fruit intake using skin carotenoid score |
| Date of disclosure of the study information | 2024/04/27 |
| Last modified on | 2025/10/31 12:44:27 |
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Basic information
Public title
Investigation of approaches to increase vegetable and fruit intake using skin carotenoid score
Acronym
Investigation of approaches to increase vegetable and fruit intake using skin carotenoid score
Scientific Title
Investigation of approaches to increase vegetable and fruit intake using skin carotenoid score
Scientific Title:Acronym
Investigation of approaches to increase vegetable and fruit intake using skin carotenoid score
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the intervention effects of providing brief nutrition education or vegetable/fruit beverages by measuring skin carotenoid scores.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin carotenoid score
Key secondary outcomes
Blood pressure and arterial stiffness indices
Visual Analog Scale scores for skin and bowel conditions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Providing brief nutrition education
Interventions/Control_2
Providing vegetable and fruit beverages
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
University student
Key exclusion criteria
Those with allergies to vegetables or fruits
Those who have difficulty eating carrots, mangoes, or mandarins
Those who cannot stop consuming vegetable or fruit drinks or supplements containing carotenoids during the study period
Smokers
Those who have difficulty taking measurements with their fingertips
Those who have difficulty completing the survey form
Those undergoing treatment or medication
Pregnant or breastfeeding
Target sample size
44
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
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2024 | Year | 04 | 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
| Delay expected |
Results Delay Reason
Currently preparing to submit a paper
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 | 02 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 04 | Month | 26 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061968
