UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057092 |
|---|---|
| Receipt number | R000065107 |
| Scientific Title | A demonstration experiment regarding the development of a "Food Support Solution" |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/02/20 14:06:44 |
* 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
A demonstration experiment regarding the development of a "Food Support Solution"
Acronym
A demonstration experiment regarding the development of a "Food Support Solution"
Scientific Title
A demonstration experiment regarding the development of a "Food Support Solution"
Scientific Title:Acronym
A demonstration experiment regarding the development of a "Food Support Solution"
Region
| Japan |
Condition
Condition
Astronauts and travelers staying in outer space
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a solution that supports dietary life, enabling the crew to maintain eating habits as close to those on Earth as possible, even in the limited resource environment of outer space (such as limited ingredients, cooking utensils, and personnel). In this study, 4 to 8 adults from different organizations will live together as a crew, utilizing the prototype of the currently developing food support solution. The goals are to evaluate its usefulness, assess menu plans combining existing space foods, and identify conflicts related to food in a group living environment. The insights gained will serve as reference information for the further development of the food support solution.The specific functions of the food support solution include five types: menu proposal, role assignment proposal, cooking process assistance, rule making, and inventory management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Taste, quantity, variety, and ease of preparation of the menu
2. Effectiveness, ease of use, and additional functions needed for the food support solution
3. Friction and its resolution methods when performing a series of meal-related activities (from menu planning to cooking to cleaning up) with others
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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 |
Interventions/Control_1
1. Menu proposals by the menu proposal function (it is possible to select options other than the proposed menu)
Propose three meals per day (breakfast, lunch, and dinner) for a period of 3 to 14 days.
2. Role assignment proposals by the role assignment proposal function (it is possible to select individuals other than those proposed for the roles through discussion)
Propose one person each for the roles of dinner cooking and cleaning for a period of 3 to 14 days.
3. Rule-making support by the rule-making support function
For a period of 3 to 14 days, initiate and facilitate discussions on group hygiene and living rules according to the preferences of the participants (discussions are conducted anonymously).
4. Cooking process support by the cooking process support function
For a period of 3 to 14 days, provide the participants who are cooking with various media that show the cooking process (such as paper, tablets, or AR goggles).
5. Food
For a period of 3 to 14 days, participants can consume only the provided foods for three meals a day (breakfast, lunch, and dinner), including Japanese space food, prepared dishes, fresh vegetables, and snacks (nutritional value verified for the three major nutrients).
Interventions/Control_2
1. Menu proposals by the menu proposal function (it is possible to choose options other than the proposed menus)
Propose three meals per day (breakfast, lunch, and dinner) for a period of 3 to 14 days.
2. Exclusion from role assignments by the role assignment proposal function
Be excluded from the roles of dinner cooking and cleaning for a period of 3 to 14 days (the individual can take on these roles if they wish and other participants agree).
3. Rule-making support by the rule-making support function
For a period of 3 to 14 days, initiate and facilitate discussions on group hygiene and living rules according to the preferences of the participants (discussions are conducted anonymously).
4. Cooking process support by the cooking process support function
For a period of 3 to 14 days, provide the participants who are cooking with various media that show the cooking process (such as paper, tablets, or AR goggles) for three meals a day (breakfast, lunch, and dinner).
5. Food
For a period of 3 to 14 days, participants can consume only the provided foods for three meals a day (breakfast, lunch, and dinner), including Japanese space food, prepared dishes, fresh vegetables, and snacks (nutritional value verified for the three major nutrients).
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 20 years old and above, under 60 years old
2. No gender preference
3. Over the past year, the individual must have had all items in their health examination categorized as either "No abnormalities," "Noted health," or "Requires follow-up" (No items requiring re-examination, detailed examination, treatment, or currently undergoing treatment).
4. The individual must be able to participate in the study both professionally (able to work remotely for several days) and personally (the participation should be voluntary, and they should not be compelled by suggestions or mandates from their superiors).
Key exclusion criteria
None
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Mitake |
| Middle name | |
| Last name | Mizuho |
Organization
NTT DATA Japan Corporation
Division name
CPG Division, Second Industry Business Sector
Zip code
1356033
Address
Toyosu Center Building, 3-3-3 Toyosu, Koto-ku, Tokyo
TEL
080-1124-0937
Mizuho.Mitake@nttdata.com
Public contact
Name of contact person
| 1st name | Fujii |
| Middle name | |
| Last name | Sayaka |
Organization
NTT DATA Japan Corporation
Division name
CPG Division, Second Industry Business Sector
Zip code
1356033
Address
Toyosu Center Building, 3-3-3 Toyosu, Koto-ku, Tokyo
TEL
080-1011-3564
Homepage URL
Sayaka.Fujii@nttdata.com
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
General Incorporated Association SPACE FOODSPHERE, National Institutes of Biomedical Innovation, Health and Nutrition, Kewpie Corporation
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Leave a Nest Co., Ltd.
Address
1-4 Shimomiyabicho, Shinjuku-ku, Tokyo, Iidabashi Miyuki Building
Tel
03-5227-4198
rd@lnest.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 | 02 | 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
4
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065107
