The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones

Study Overview
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Brief Summary
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The aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with type 2 diabetes.

Detailed Description
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Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate days in random order with 1-2 week intervals. These participants will consume protein enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180 min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to 180 min will be calculated.

Official Title
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The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones in Healthy Adults and Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: premeal protein-enriched bar intake
* Other: breakfast follows by protein bar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18.5 35 kg/m2 Healthy volunteer: never diagnosed by diabetes and fasting plasma glucose <=100mg/dl and HbA1c <6.0% participants with diabetes diagnosed by diabetes if treated by diet, HbA1c 6.0 9.0% if treated by metformin or SU, HbA1c 6.0 10.0% if treated by DPP4 inhibitor HbA1c 6.0 9.0% Exclusion Criteria: Those who diagnosed by Type 1 diabetes History of DKA History of insulin therapy Allergy to wheat, flour, nuts, milk Pregnancy/lactation AST or ALT >2.5 times of upper normal reference range eGFR <30 mL/min/1.73m2 Hb <10g/dl History of GI surgery (except hemorrhoidectomy, appendectomy)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: premeal protein bar first<br>intervention: premeal protein-enriched bar intake protein enriched bar(total serving: 30g, 43.28% carbohydrate; 1.29% fat; 40.39% protein; 42.63% fiber) will be given 30 minutes before breakfast protein enriched bar is provided with 150 ml of water amount of protein bar : 30g breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml | Dietary Supplement: premeal protein-enriched bar intake<br>* Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.<br>* Other names: premeal protein bar;|
| Other: breakfast first<br>intervention: breakfast follows by protein bar protein enriched bar is provided with 150 ml of water shortly after breakfast amount of protein bar : 30g breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml | Other: breakfast follows by protein bar<br>* Participants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| Area under the curve (AUC) of plasma glucose level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma total/active GLP-1 level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| Area under the curve of plasma total/active GLP-1 level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| plasma GIP level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| Area under the curve of plasma GIP level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| plasma insulin level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| Area under the curve of plasma insulin level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| plasma C-peptide level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| Area under the curve of plasma C-peptide level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| plasma glucagon level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 
| Area under the curve of plasma glucagon level after breakfast |  | -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, incretin hormone, glucose level, GLP-1, GIP, premeal protein