A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease

Celio Technology

Status: Completed

Conditions: Type II Diabetes Mellitus

Treatments: Dietary Supplement: Musashino T2DM diet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02446054

2013CMP-V2

Details and patient eligibility

About

Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control

Full description

In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Enrollment: 30 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A baseline of glycosylated hemoglobin(HbA1c) is, 10%≥HbA1c≥7%, during past 1 month
• The subject is able to understand and comply with protocol requirements, instrument
• The subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess
• Signed and dated written informed consent

Exclusion criteria

• Pregnancy, breastfeeding or planning to become pregnant during the study
• Acute illness or infection requiring treatment within 14 days of study entry
• Other serious disease (e.g. Heart, lung, brain, liver) within 3 months
• Presence of malignancies
• Participate in other clinical trial within 30 days prior to this study
• Alcohol or drug abuse that would interfere with the ability to meet study requirements (opinion of investigator)
• Concurrent significant medical condition that would limit ability to participate in the study
• Consider by the investigator to be unsuitable for study participation, for any reason

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

One Arm Study

Experimental group

Description:

provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Treatment:

Dietary Supplement: Musashino T2DM diet