Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study)

Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study) - Effectiveness of an Optimized Nutri-Dense Meals for Patients with Type 2 Diabetes Mellitus (Intervention Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057718

Enrollment

170

Registered

2026-01-01

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

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 wi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
CGM profile just before the end of the intervention	—

Secondary

Measure	Time frame
CGM profile at intake of designated meals after the end of the intervention	—

Countries

Japan

Contacts

Public ContactTsugumi Uema

Graduate School of Medicine, University of the Ryukyus Division of Endocrinology, Diabetes and Metabolism, Hematology, Rheumatology

ma2.ky8.26@gmail.com098-894-1468

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026