UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057803 |
|---|---|
| Receipt number | R000066051 |
| Scientific Title | Examination of the effects of the meal design system app on dietary habits and physical condition, including skin condition. |
| Date of disclosure of the study information | 2025/05/08 |
| Last modified on | 2026/01/16 17:18:46 |
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Basic information
Public title
Study of daily logging to improve dietary habits
Acronym
Examination of the effects of the meal design system app on dietary habits and physical condition, including skin condition.
Scientific Title
Examination of the effects of the meal design system app on dietary habits and physical condition, including skin condition.
Scientific Title:Acronym
Examination of the effects of the meal design system app on dietary habits and physical condition, including skin condition.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of using the meal design system app for 4 weeks on dietary habits and physical condition, including skin condition, in a randomized, double-blind, parallel-group comparison study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on Attitudes Toward Food and Eating Behavior
Key secondary outcomes
BDHQ, Questionnaire on physical condition, Questionnaire on skin condition, Skin test, Intestinal environment test, Questionnaire on stool
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
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sham App and Skin Care Program A
Interventions/Control_2
Meal Design System App and Skin Care Program A
Interventions/Control_3
Meal Design System App and Skin Care Program B
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Those who fully understand the significance, content, and purpose of this study and have given written or electromagnetic consent to participate in this study.
2. Japanese men and women who are between 18 and 40 years of age.
3. Those who are willing to improve their dietary habits.
4. Those who are suitable for this study based on their skin condition.
5. Those who have a daily skin care habit.
Key exclusion criteria
1. Those who are receiving medical treatment, medication, or lifestyle guidance due to schizophrenia, depression, mania, neurological disorders, sleep disorders, or chronic fatigue syndrome.
2. Those who are receiving nutritional guidance at a medical institution.
3. Those who are visiting a hospital or taking medication for treatment of liver disease, kidney disease, digestive disease, or lifestyle-related diseases (hypertension, hyperglycemia, hyperuricemia, cardiac disease, high cholesterol, etc.).
4. Those with skin disease symptoms such as atopic dermatitis, contact dermatitis, etc.
5. Those who have experienced allergic symptoms (including itchiness and rash) or are at risk of developing allergic symptoms when applying cosmetics.
6. Those with serious food allergies.
7. Women who are pregnant or may become pregnant, and women who are breastfeeding.
8. Women with irregular menstrual cycles
9. Those who have received specialized training in nutrition.
10. Those who live with a nutritionist.
11. Those who plan to undergo a major lifestyle change between the time of consent and the completion of the study.
12. Those who will participate in other clinical trials, observational studies, clinical trials, or home-use testing between the date of consent and the completion of the study.
13. Those who have undergone or will undergo cosmetic medical treatment or special skin care procedures (e.g., peels, hair removal treatments) on the face within 4 weeks prior to the date of consent or before the end of the study.
14. Those who are currently using any medicines (including over-the-counter products) or supplements that have a female hormone effect.
15. Those who are otherwise determined to be ineligible by the investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nishihira |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nishihira |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization, bio-oriented technology Research Advancement Institution
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Agriculture and Food Research Organization
KOSE Corporation
National Institute of Advanced Industrial Science and Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
| 2025 | Year | 05 | Month | 08 | 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 | 04 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2025 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066051
