UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056442 |
|---|---|
| Receipt number | R000064113 |
| Scientific Title | A single-center prospective study on the clinical significance of post-gastrectomy diet using an AI menu/nutrition management app |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/12/16 10:33:56 |
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Basic information
Public title
A single-center prospective study on the clinical significance of post-gastrectomy diet using an AI menu/nutrition management app
Acronym
A study on the clinical significance of post-gastrectomy diet using an AI menu/nutrition management app
Scientific Title
A single-center prospective study on the clinical significance of post-gastrectomy diet using an AI menu/nutrition management app
Scientific Title:Acronym
AI app Post-gastrectomy Dietary Intervention Study
Region
| Japan |
Condition
Condition
Gastric Cancer, Esophagogastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to improve dietary intake, suppress weight and skeletal muscle loss, and improve blood glucose trends by using an AI menu/nutrition management app for patients after gastric cancer surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of controlling weight and skeletal muscle loss after gastrectomy by intervention of AI menu/nutrition management app
Key secondary outcomes
Effect of improving dietary intake and blood glucose trends after gastrectomy by intervention of AI menu/nutrition management app
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
AI menu/nutrition management app
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who visited our hospital between the date of approval and March 31, 2027
2. Patients aged 20 years or older and younger than 80 years at the time of consent for surgery
3. Patients who have been diagnosed with gastric cancer and have undergone radical gastric surgery (distal gastrectomy, total gastrectomy, or proximal gastrectomy)
4. Patients who have a smartphone or computer and can use the app
Key exclusion criteria
1. Women who are pregnant or may become pregnant
2. Patients participating in clinical research with other invasions (including minor invasions) that are considered to be related to this study
3. Patients judged to be inappropriate by the physician or co-investigator
4. Patients requiring enteral nutrition after discharge
5. Patients who could not consent to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kubota |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Department of Digestive Surgery
Zip code
602-8566
Address
465,Kajii-cho, Kawaramachi-hirokoji,Kamigyo-ku, Kyoto
TEL
075-251-5527
tkubot@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kubota |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Department of Digestive Surgery
Zip code
602-8566
Address
465,Kajii-cho, Kawaramachi-hirokoji,Kamigyo-ku, Kyoto
TEL
075-251-5527
Homepage URL
tkubot@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oishi kenko Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kyoto Prefectural University of Medicine
Address
465,Kajii-cho, Kawaramachi-hirokoji,Kamigyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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 | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 09 | Month | 30 | Day |
Other
Other related information
Post-gastrectomy symptoms, QOL, and glycemic variability will be examined one year after usage of an AI menu/nutrition management app.
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064113
