UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054178 |
|---|---|
| Receipt number | R000061859 |
| Scientific Title | Exploratory Research Aims to Develop a Digital Diet Improvement Program for the Elderly |
| Date of disclosure of the study information | 2024/04/18 |
| Last modified on | 2024/04/17 15:23:03 |
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Basic information
Public title
Exploratory Research Aims to Develop a Digital Diet Improvement Program for the Elderly
Acronym
Exploratory Research Aims to Develop a Digital Diet Improvement Program for the Elderly
Scientific Title
Exploratory Research Aims to Develop a Digital Diet Improvement Program for the Elderly
Scientific Title:Acronym
Exploratory Research Aims to Develop a Digital Diet Improvement Program for the Elderly
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of a dietary improvement program, which includes online self-reported dietary records, online dietary advice, and offering balanced meals, on dietary habits and both physiological and psychological health in elderly participants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usage and retention of online self-reported dietary record and dietary advice during the intervention period.
Key secondary outcomes
- Body measurement
- Self-checked brain health
- Physical ability assessment
- Revised Japanese version of the Cardiovascular Health Study criteria (revised J-CHS criteria)
- Lifestyle questionnaire
- Post-intervention questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
- online self-reported simple dietary records
- offering online dietary advice
- offering balanced meals (optional)
- participating in nutrition counseling workshops (optional)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Those who reside in the municipalities where the research is conducted
- Those who are more than 65 years old as of June 1st 2024
- All genders
Key exclusion criteria
- Those with food allergies
- Those receiving regular nutritional counseling
- Those with dysphagia
- Those certified as requiring care
- Those aware of blood pressure above 160/100 mmHg within past one month
- Those who cannnot use online tools with electric devices
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Takada |
Organization
AJINOMOTO CO., INC.
Division name
Research Institute for Bioscience Products and Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa Prefecture
TEL
070-1002-5063
michihiro.takada.c5v@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Kitamura |
Organization
AJINOMOTO CO., INC.
Division name
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa Prefecture
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa Prefecture
TEL
070-1002-6488
Homepage URL
hitomi.kitamura01.mx9@asv.ajinomoto.com
Sponsor or person
Institute
AJINOMOTO CO., INC.
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO., 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
Ethics Committee of Ajinomoto Co., Inc.
Address
1-15-1,Kyobashi, Chuo-ku, Tokyo
Tel
03-5250-8111
ajinomoto_irb@asv.ajinomoto.com
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
| 2024 | Year | 04 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | 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
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061859
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
