UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053911 |
|---|---|
| Receipt number | R000061537 |
| Scientific Title | Once-daily consumption of nutritionally balanced home-delivered meals for weight management in people with type 2 diabetes |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/08 11:32:49 |
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Basic information
Public title
Once-daily consumption of nutritionally balanced home-delivered meals for weight management in people with type 2 diabetes
Acronym
Once-daily consumption of nutritionally balanced home-delivered meals for weight management in people with type 2 diabetes
Scientific Title
Once-daily consumption of nutritionally balanced home-delivered meals for weight management in people with type 2 diabetes
Scientific Title:Acronym
Once-daily consumption of nutritionally balanced home-delivered meals for weight management in people with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal whether a once-daily consumption of nutritionally balanced home-delivered meals will reduce body weight in people with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in body weight at 12 weeks
Key secondary outcomes
- Percent change in body weight at 6 weeks
- Change in waist circumference at 6 and 12 weeks
- Change in hemoglobin A1c levels at 6 and 12 weeks
- Change in diet-related quality of life at 6 and 12 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
To replace everyday meals with nutritionally balanced home-delivered ones (test meals) once daily
Interventions/Control_2
To have everyday meals
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
Outpatients with type 2 diabetes mellitus who have increased body mass index (>= 25 kg/m2) or increased waist circumference (>= 85 cm in males and >= 90 cm in females) and require weight reduction
Key exclusion criteria
- People for whom test meals are not medically appropriate (e.g., people with renal failure, those with hepatic failure, those with food allergy, and those with intense activity and greater nutritional needs)
- People who are unable to prepare test meals as directed
- People who are scheduled to have a long trip or in-hospital treatment during the study period
- People in whom anti-diabetic or anti-obesity medications will be started, changed, or stopped during the study period
- People with a pacemaker
- People participating in another clinical trial
- People whose participation in this clinical trial is considered inappropriate by their attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Iichiro |
| Middle name | |
| Last name | Shimomura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamada-oka, Suita City, Osaka
TEL
81.6.6879.3732
shimomura@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Shiraiwa |
Organization
Shiraiwa Medical Clinic
Division name
Shiraiwa Medical Clinic
Zip code
582-0005
Address
4-10-24, Hozenji, Kasiwara City, Osaka
TEL
81.72.971.1221
Homepage URL
shiraiwa@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOOD PRODUCTS CO.,LTD.
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
Institutional Review Board of Osaka University Hospital
Address
2-2 Yamada-oka, Suita City, Osaka
Tel
81.6.6210.8296
rin-sokatu@dmi.med.osaka-u.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
| 2024 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | 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 | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061537
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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