UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059966 |
|---|---|
| Receipt number | R000068588 |
| Scientific Title | Evaluation program for dietary support |
| Date of disclosure of the study information | 2025/12/04 |
| Last modified on | 2025/12/04 11:12:17 |
* 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
Evaluation program for dietary support
Acronym
Evaluation program for dietary support
Scientific Title
Evaluation program for dietary support
Scientific Title:Acronym
Evaluation program for dietary support
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how health awareness and health behaviors are changed in adults aged 35 years or older by the consumption of frozen meals twice a week), in combination with a habit-formation program and guidance by a registered dietitian for seven weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related awareness and behavior questionnaire before and 7 weeks after the intervention.
Key secondary outcomes
Quality of life questionnaire, BMI, weight, and waist circumference before and 7 weeks after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
Intake of frozen meals twice a week for 7 weeks.
To record daily meals in the specified app.
Advice from a registered dietitian.
Interventions/Control_2
Intake of frozen meals twice a week for 7 weeks.
To record daily meals in the specified app.
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate by providing electronic consent.
2.Persons who are 35 years old or more and work at the TOPPAN Koishikawa Headquarters Building.
3.Including persons who subject to specific health guidance with /without currently taking medication.
Key exclusion criteria
1.Persons who have a serious disease history.
2.Persons who have food allergies.
3.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam.
4.Persons who were judged as inappropriate for study participants by the principal investigator.
5.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding.
6.Persons who cannot agree to the provision of personal information required for the study, or who cannot agree to the collection and use of data in this project (such as app usage logs, chat logs, and dietary records).
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
TOPPAN Inc.
Division name
Information & Communication Division
Zip code
112-8531
Address
1-3-3, Suido, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3835-5111
kaoru.yamashita@toppan.co.jp
Public contact
Name of contact person
| 1st name | Hisao |
| Middle name | |
| Last name | Morikawa |
Organization
TOPPAN Inc.
Division name
Information & Communication Division
Zip code
112-8531
Address
1-3-3, Suido, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3835-5111
Homepage URL
hisao.morikawa@toppan.co.jp
Sponsor or person
Institute
TOPPAN Inc.
Institute
Department
Personal name
Funding Source
Organization
TOPPAN Inc.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 12 | Month | 04 | 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
| 2025 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068588
