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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes

Conditions
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Patients With Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Premeal protein enriched bar
* Behavioral: Dietary modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premeal protein group<br>Premeal protein enriched bar with dietary modification | Dietary Supplement: Premeal protein enriched bar<br>* Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).<br>Behavioral: Dietary modification<br>* Subjects in this group will follow diabetes diet education.<br>|
| Other: Dietary modofication only group<br>Dietary modification only | Behavioral: Dietary modification<br>* Subjects in this group will follow diabetes diet education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline |  | 0 week, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Blood Triglyceride Level From Baseline |  | 0 week, 12 weeks | 
| Change in Blood High-density Lipoprotein Level From Baseline |  | 0 week, 12 weeks | 
| Change in Blood Low-density Lipoprotein Level From Baseline |  | 0 week, 12 weeks | 
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline | 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. | 0 week, 12 weeks | 
| Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline | 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. | 0 week, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein-enriched bar, glycemic control, type 2 diabetes, long term