Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes

Not Applicable

Completed

Interventions: Dietary Supplement: Premeal protein enriched bar
Behavioral: Dietary modification

Brief Summary: The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.

Detailed Description: Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.

Recruitment & Eligibility

Inclusion Criteria

BMI 18.5~35 kg/m2
Type 2 diabetes patients
Fasting blood glucose ≥ 126 mg/dl or
HbA1c ≥ 6.5% or
Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin.

Exclusion Criteria

HbA1c < 6.5% or > 10%
Subjects using insulin other than basal insulin
Subjects who have newly started or have changed anti diabetic drugs within 3 months
Subjects who are allergic to grains, nuts, legumes and milk
Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery)
Subjects with chronic unstable disease
Subjects with cognitive impairments who are not able to follow the study protocol
Females who are pregnant or doing breast feeding
Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges
Subjects with hemoglobin level of less than 10.0 g/dL
Subjects with alcohol addiction or drug abuse

Arm && Interventions

Group	Intervention	Description
Premeal protein group	Premeal protein enriched bar	Premeal protein enriched bar with dietary modification
Premeal protein group	Dietary modification	Premeal protein enriched bar with dietary modification
Dietary modofication only group	Dietary modification	Dietary modification only

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline	0 week, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Blood High-density Lipoprotein Level From Baseline	0 week, 12 weeks
Change in Fasting Blood Glucose Level From Baseline	0 week, 12 weeks
Change in Body Weight From Baseline	0 week, 12 weeks
Change in Waist Circumference From Baseline	0 week, 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline	0 week, 12 weeks	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.
Change in Blood Low-density Lipoprotein Level From Baseline	0 week, 12 weeks
Change in Blood Triglyceride Level From Baseline	0 week, 12 weeks
Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline	0 week, 12 weeks	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.