UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057718 |
|---|---|
| Receipt number | R000065950 |
| Scientific Title | Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study) |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/04/25 15:29:37 |
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Basic information
Public title
Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study)
Acronym
Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study)
Scientific Title
Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study)
Scientific Title:Acronym
Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study)
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 evaluate the benefit of a diet incorporating a balanced diet (Optimized Nutri-Dense Meals) compared to a conventional diet and nutritional support alone for patients with type 2 diabetes.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CGM profile just before the end of the intervention
Key secondary outcomes
CGM profile at intake of designated meals after the end of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The study group will receive normal dietary and nutritional support and will consume the designated meals every meal (6 meals) for 2 consecutive days on the first day of the study. Thereafter, they will consume one meal per day of the study food (Optimized Nutri-Dense Meals) for 12 weeks. After the intervention, participants will continue to consume the designated meals for 2 consecutive days (6 meals). Continuous glucose monitoring (CGM) will be performed during the intake period of the designated meals (twice before and after the intervention) and for two days before the end of the intervention to compare the effect of improvement in blood glucose variability patterns.
Interventions/Control_2
The control group will receive regular dietary and nutritional support and will be asked to consume the designated meals every 2 consecutive days (6 meals) on the first day of the study, for 12 weeks, they are required to consume a diet based on dietary and nutritional support. 12 weeks later, they will continue to consume the designated meals every 2 consecutive days (6 meals). Continuous glucose monitoring (CGM) will be performed during the specified meal intake period (twice before and after the intervention) and on two days before the end of the intervention to compare the effect of improvement in blood glucose variability patterns.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and female over 30 years of age with type 2 diabetes and HbA1c 6.5-8.0% with no change in drug therapy for at least the past 3 months
Key exclusion criteria
1. Those who have been diagnosed with type 2 diabetes for less than 6 months
2. Who are on insulin therapy
3. Who, at the time of pre-screening, are scheduled to undergo a change in diabetes treatment or to add or discontinue a new medication during the study period.
4. Whose BMI is less than 18.5 kg/m2
5. Who have food allergies
6. Who are shift workers
7. Those with contraindications to CGM or body composition monitoring (* pacemakers, etc.)
8. Who are unable to use the smartphone application of the CGM (those who own a non-compatible smartphone or are unable to operate the application)
9. Who are or may be pregnant or lactating
10. Who are unable to continuously consume the research food due to long business trips or travel during the intervention period
11. Who are unable to properly store or consume the research foods (*unable to set up a freezer to be distributed, do not have a microwave oven, etc.)
12. Who are participating in other clinical studies at the time this study is initiated
13. Who are judged by the investigator to be unsuitable to participate in the study
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Masuzaki |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatology
Zip code
901-2720
Address
1076 Kiyuna, Ginowan, Okinawa
TEL
098-894-1468
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Uema |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatology
Zip code
901-2720
Address
1076 Kiyuna, Ginowan, Okinawa
TEL
098-894-1468
Homepage URL
ma2.ky8.26@gmail.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
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 the University of the Ryukyus for Medical and Health Research Involving Human Participants
Address
1076 Kiyuna, Ginowan, Okinawa
Tel
098-894-1364
krinken@acs.u-ryukyu.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
琉球大学病院（沖縄県）他、沖縄県本島内の医療機関
Other administrative information
Date of disclosure of the study information
| 2026 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | 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 | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065950
