Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057718) titled 'Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study)' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - University of the Ryukyus

Condition: Condition - Type 2 Diabetes Mellitus Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 170

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 04 Month 25 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2027 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065950

Disclaimer: Curated by HT Syndication.