UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055709 |
|---|---|
| Receipt number | R000050081 |
| Scientific Title | Encouragement for university students to increase vegetable intake using an equipment to measure skin carotenoid levels |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2025/10/03 18:11:30 |
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Basic information
Public title
Encouragement for university students to increase vegetable intake using an equipment to measure skin carotenoid levels
Acronym
Evaluation of vegetable intake in university students
Scientific Title
Encouragement for university students to increase vegetable intake using an equipment to measure skin carotenoid levels
Scientific Title:Acronym
Evaluation of vegetable intake in university students
Region
| Japan |
Condition
Condition
Healthy university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of food education in university students using Veggie Meter which measures skin carotenoid levels
Basic objectives2
Others
Basic objectives -Others
To verify the effectiveness of food education
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in skin carotenoid levels at six months after
Key secondary outcomes
The change in skin advanced end products (AGEs) levels at six months after
Improvement of vegetable intake evaluated by food intake questionnaire at six months after
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Measurements of skin carotenoid and AGEs levels
Quick dietary guidance
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
| 18 | years-old | <= |
Age-upper limit
| 28 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students who study nutrition or students who do not study nutrition
with consent
Key exclusion criteria
without consent
Target sample size
334
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Ophthalmology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka, Japan
TEL
0534742222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Mitsuo |
| Middle name | Obana |
| Last name | Kimata |
Organization
Seirei Hamamatsu General Hospital
Division name
Clinical research center
Zip code
4308558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka, Japan
TEL
0534742222
Homepage URL
http://www.seirei.or.jp/hamamatsu/
m-kimata@sis.seirei.or.jp
Sponsor or person
Institute
Departement of Ophthalmology, Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Departement of Ophthalmology, Seirei Hamamatsu General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Faculty of Health Promotional Sciences, Tokoha University, Hamamatsu City
Name of secondary funder(s)
Faculty of Health Promotional Sciences, Tokoha University, Hamamatsu City
IRB Contact (For public release)
Organization
Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka, Japan
Tel
0534742222
m-kimata@sis.seirei.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-001H
Org. issuing International ID_1
Tokoha University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
常葉大学浜松キャンパス
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
https://drive.google.com/file/d/1Z4Xd1S-BokWSdM0MhXDndIzyPQdmFZjK/view?usp=sharing
Publication of results
Published
Result
URL related to results and publications
https://drive.google.com/file/d/1Z4Xd1S-BokWSdM0MhXDndIzyPQdmFZjK/view?usp=sharing
Number of participants that the trial has enrolled
323
Results
Primary outcomes: Veggie score rose from 319 at baseline to 331 at 1 month (p<0.05), then fell to 313 at 6 months (p<0.01). Secondary outcomes: AGEs score increased from 0.43 to 0.45 at 1 month (p<0.05) and 0.46 at 6 months (p<0.01 vs baseline). Daily intake frequency of total and green/yellow vegetables showed no significant change at 6 months (p=0.063, p=0.849).
Results date posted
| 2025 | Year | 10 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male: 53%; Living with family: 59%; Third- or fourth-year university students: 57%; Members of athletic clubs: 51%
Participant flow
Of the 323 participants who provided consent, 322 underwent the baseline measurement (1 not measured), 301 underwent the 1-month measurement (22 not measured), 206 underwent the 6-month measurement (117 not measured).
Adverse events
None
Outcome measures
Veggie score, AGEs score, and dietary intake frequency survey (frequency of vegetable intake)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050081
