An open-label, randomized, controlled, parallel-group comparative study on the effectiveness of 111-lunchbox dietary method as a dietary management in type 2 diabetic patients

An open-label, randomized, controlled, parallel-group comparative study on the effectiveness of 111-lunchbox dietary method as a dietary management in type 2 diabetic patients - Study on the effectiveness of 111-lunchbox dietary method as a new dietary regimen for calorie-restricted diets in diabetes treatment. (111-lunchbox study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003494

Enrollment

Registered

2010-04-28

Start date

2010-06-01

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

111-lunchbox group: In addition to the conventional dietary treatment, 111-lunchbox dietary method is guided by nationally registered dietitian. Periodic guidance is repeated during the 6-month stud

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with type 2 diabetes mellitus. 2.Age 40 to less than 80 years. 3.Undergoing dietary treatment 4.Patients with HbA1c of 6.0-9.0% at entry. 5.No initiation or changes in hypoglycemic drugs or antidyslipidemic drugs within the 2-month period preceding initiation of the study.

Exclusion criteria

Exclusion criteria: 1.Complication by stage 3B or more severe diabetic nephropathy, or stage 3 or more severe chronic kidney disease (CKD) not associated with diabetes. 2.Malignant or acute disease. 3.Severe liver disease. 4.Decreased pancreatic function due to chronic pancreatitis, etc. 5.Past history of surgery of the gastrointestinal tract or complication by gastrointestinal disease requiring dietary restriction. 6.Heart failure. 7.Pregnant or lactating women 8.Under steroid treatment 9.Patient judged to have difficulty in performing dietetics on his/her own due to dementia, etc. 10.Other patients judged unsuitable by the attending physician.

Design outcomes

Primary

Measure	Time frame
Glycemic control status (HbA1C)	—

Secondary

Measure	Time frame
1.Body weight, BMI 2.Other measures of glycemic status (FPG, 1,5-AG, IRI, rate of achievement of glycemic goal (HbA1c < 7.0 or < 6.5%)) 3.Lipid profile 4.Proteinuria/Albuminuria 5.Intake survey 6.Level of satisfaction with therapy, QOL (questionnaire survey) 7.Adherence	—

Countries

Japan

Contacts

Public ContactShinya Fukumoto

Osaka City University Graduate School of Medicine Department of Metabolism, Endocrinology and Molecular Medicine

06-6645-3806

Outcome results

None listed

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