UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054137 |
|---|---|
| Receipt number | R000061695 |
| Scientific Title | Validation of meal coaching based on chrono-nutrition |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/12 17:56:01 |
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Basic information
Public title
Validation of meal coaching based on chrono-nutrition
Acronym
Validation of meal coaching based on chrono-nutrition
Scientific Title
Validation of meal coaching based on chrono-nutrition
Scientific Title:Acronym
Validation of meal coaching based on chrono-nutrition
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Problems surrounding the health of modern people, such as unbalanced nutritional intake, disordered eating habits (e.g., missing breakfast), obesity, slimness, and lifestyle-related diseases, are becoming more and more serious. Although it is very difficult to change a habitual diet, it is very important to improve eating habits to prevent future diseases. Current nutritional guidance such as specific health guidance defines daily dietary intake and nutritional balance, but lacks the perspective of temporal nutrition, such as intake at each mealtime of breakfast, lunch, and dinner. Therefore, this study will implement a nutritional guidance program based on the evidence of temporal nutritional science and verify whether the prevention and improvement of lifestyle-related diseases can be achieved.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in body weight
Key secondary outcomes
Instruction completion rate, abdominal circumference, blood pressure, laboratory values, psychological level, pre- and post-instruction evaluation of own health status, NPS values,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Conduct a total of 4 ICT interviews (30 minutes per interview) over a 3-month period
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who have been fully informed of the purpose and content of this study, have the capacity to consent, and fully understand and agree to participate in this study in writing.
2 Japanese adult between the ages of 40 and 65 at the time of consent
3 Subjects of specific health guidance
Key exclusion criteria
1. Those with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc.
2. Pregnant or planning to become pregnant, and those who are breastfeeding.
3. Those who have an extremely irregular diet.
4. Persons who are allergic to food
5. Who are currently participating in a clinical study of another drug or health food, and who plan to participate in another clinical study within one month of the study's completion or after consent to participate in such a study.
6. Do not have a smartphone.
7. Any other person who is deemed by the principal investigator or physician in charge of testing doctor to be inappropriate to participate in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
133-0057
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
furutani@aikoku-jc.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
133-0057
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
Homepage URL
furutani@aikoku-jc.ac.jp
Sponsor or person
Institute
Aikoku Gakuen Junior College
Institute
Department
Personal name
Funding Source
Organization
Calbee, Inc
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Co., Ltd. and Calbee, Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aikoku Gakuen Junior College
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
Tel
03-5668-7260
aioffice@aikoku-jc.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
タウンドクター株式会社
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 15 | 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
| 2024 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2027 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061695
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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