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

Not Applicable

Completed

• Conditions: Type II Diabetes Mellitus
• Interventions: Dietary Supplement: Musashino T2DM diet

• Registration Number: NCT02446054
• Lead Sponsor: Celio Technology Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-02
• Status Verified: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the change of glycosylated hemoglobin (HbA1c)	12 weeks	12 weeks diet control

Secondary Outcome Measures

Name	Time	Method
the change of patients' fasting blood Glucose	12 weeks
the change of patients' fasting serum C-peptide	12 weeks
the change of EuroQol EQ-5D questionnaire	12 weeks
the change of patients' fasting serum Insulin	12 weeks
the change of WHO-QoL questionnaire	12 weeks
the patients' compliance questionnaire	12 weeks

Trial Locations

Locations (1)

NTUH; 🇨🇳 Taipei, Taiwan