Post Prandial Glucose Control Proof-of-Principle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.

Official Title
-----------------
Post Prandial Glucose Control Proof-of-Principle

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: Carbohydrate placebo
* Other: Nutritional ingredient
* Other: #1 Nutritional ingredient +Fiber
* Other: #2 Nutritional ingredient + Fiber
* Other: #3 Nutritional ingredient + Fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes between 21 and 75 years of age male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile BMI is > 18.5 kg/m2 and <35 kg/m2 HbA1c < 9.0% Exclusion Criteria: Subject uses exogenous insulin, exenatide, or sitagliptin phosphate type 1 diabetes. history of diabetic ketoacidosis. current infection active malignancy has had a significant cardiovascular event or history of congestive heart failure. end-stage organ failure or post organ transplant. history of renal disease. hepatic disease. history of gastrointestinal disorders chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications clotting or bleeding disorders. allergic or intolerant to any ingredient found in the study products.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional ingredient<br>Dissolve in water and consume with meal | Other: Nutritional ingredient<br>* Dissolve in water and consume with meals<br>|
| Placebo Comparator: Carbohydrate<br>dissolve in water and consume with meal | Other: Carbohydrate placebo<br>* dissolve in water and consume with meal<br>|
| Experimental: #1 Nutrtitional ingredient + Fiber<br>Dissolve in water and consume with meal | Other: #1 Nutritional ingredient +Fiber<br>* Dissolve in water and consume with meal<br>|
| Experimental: #2 Nutritional ingredient + Fiber<br>Dissolve in water and consume with meal | Other: #2 Nutritional ingredient + Fiber<br>* Dissolve in water and consume with meal<br>|
| Experimental: #3 Nutritional ingredient + Fiber<br>Dissolve in water and consume with meal | Other: #3 Nutritional ingredient + Fiber<br>* Dissolve in water and consume with meal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive AUC from 0 to 240 minutes for plasma glucose. |  | 0 to 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose concentrations |  | 0 to 240 minutes |